Ignite Creation Date:
2025-12-24 @ 3:33 PM
Ignite Modification Date:
2026-02-01 @ 11:34 PM
Study NCT ID:
NCT00635492
Status:
COMPLETED
Last Update Posted:
2015-04-09
First Post:
2008-02-20
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077270', 'term': 'Exenatide'}], 'ancestors': [{'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrialTransparency@astrazeneca.com', 'title': 'Peter Ohman, Medical Science Director', 'organization': 'AstraZeneca'}, 'certainAgreement': {'otherDetails': "Bristol-Myers Squibb Co. agreements with investigators vary; constant is our right to embargo communications regarding trial results prior to public release for a period ≤60 days from submittal for review. We will not prohibit investigators from publishing, but will prohibit the disclosure of previously undisclosed confidential information other than study results, and request postponement of single-center publications until after disclosure of the clinical trial's primary publication.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': '1. Serious adverse events (SAEs) and adverse events (AEs) were not collected as part of this observational study\n2. Factors associated with treatment choice : this analysis was done on baseline lock( april 2009) where all others are from final lock.'}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20 ug', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Insulin', 'description': 'Insulin at a dose selected by the HCP and patient', 'otherNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1113', 'groupId': 'OG000'}, {'value': '1273', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'daily dose ranging from 5-20mcg/day'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'title': 'Estimate at 24 months', 'categories': [{'measurements': [{'value': '53.9', 'spread': '123', 'groupId': 'OG000', 'lowerLimit': '50.8', 'upperLimit': '57.0'}, {'value': '60.6', 'spread': '123', 'groupId': 'OG001', 'lowerLimit': '57.7', 'upperLimit': '63.5'}]}]}, {'title': 'Estimate at 12 months', 'categories': [{'measurements': [{'value': '67.8', 'groupId': 'OG000', 'lowerLimit': '65.0', 'upperLimit': '70.6'}, {'value': '70.6', 'groupId': 'OG001', 'lowerLimit': '68.0', 'upperLimit': '73.1'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 24', 'description': 'The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time.\n\nInitial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study.\n\nSignificant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following:\n\nInsulin:\n\n* Addition of a new medication for the treatment of type 2 diabetes\n* A change in the number of times insulin is administered per day\n* Discontinuation of any insulin initiated at baseline\n* Substitution of a human insulin for an analogue insulin or vice-versa.\n* Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change.\n\nExenatide:\n\n* Addition of a new medication for the treatment of type 2 diabetes\n* Discontinuation of exenatide.', 'unitOfMeasure': 'probability (%)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'All patients who provided consent to release information and who fulfil the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes.'}, {'type': 'SECONDARY', 'title': 'Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1177', 'groupId': 'OG000'}, {'value': '1315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20mcg/day'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'Insulin at a dose selected by the HCP and patient'}], 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '6.5', 'groupId': 'OG000', 'lowerLimit': '1.13', 'upperLimit': '1.19'}, {'value': '29.7', 'spread': '5.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.16', 'ciLowerLimit': '1.13', 'ciUpperLimit': '1.19', 'groupDescription': 'Body Mass Index (BMI) - 1kg/m² higher', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Higher BMI was one of the Factors evaluated for association with treatment choice at baseline. BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m\\^2). The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m\\^2 higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.'}, {'type': 'SECONDARY', 'title': 'Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1177', 'groupId': 'OG000'}, {'value': '1315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'daily dose ranging from 5-20mcg/day'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '1.4', 'groupId': 'OG000'}, {'value': '9.2', 'spread': '1.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.77', 'ciLowerLimit': '0.69', 'ciUpperLimit': '0.86', 'groupDescription': 'Most recent HbA1c at baseline - 1% higher.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin. The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher.', 'unitOfMeasure': 'percent of hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.'}, {'type': 'SECONDARY', 'title': 'Older Age Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1114', 'groupId': 'OG000'}, {'value': '1274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'daily dose ranging from 5-20mcg/day'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '63.7', 'spread': '10.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.96', 'ciLowerLimit': '0.95', 'ciUpperLimit': '0.97', 'groupDescription': 'Age - 1 year older', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline. The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).', 'unitOfMeasure': 'years', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.'}, {'type': 'SECONDARY', 'title': 'Disinhibited Eating Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '386', 'groupId': 'OG000'}, {'value': '446', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'daily dose ranging from 5-20mcg/day'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'categories': [{'measurements': [{'value': '43.52', 'spread': '20.99', 'groupId': 'OG000'}, {'value': '34.38', 'spread': '20.33', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0083', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.05', 'ciLowerLimit': '1.01', 'ciUpperLimit': '1.10', 'groupDescription': 'Diabetes Health Profile - 18 (DHP-18) subscale disinhibited eating - Yes vs. No', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction. The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline. The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who provided consent to release information, fulfilled the study entry criteria, provided the specific data (DHP-18 subscale on disinhibited eating) and had a start date provided were included in the analyses.'}, {'type': 'SECONDARY', 'title': 'Higher Random Glucose Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1177', 'groupId': 'OG000'}, {'value': '1315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'daily dose ranging from 5-20mcg/day'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'categories': [{'measurements': [{'value': '10.37', 'spread': '3.13', 'groupId': 'OG000'}, {'value': '12.13', 'spread': '4.36', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0141', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.94', 'ciLowerLimit': '0.90', 'ciUpperLimit': '0.99', 'groupDescription': 'Random blood glucose - 1 mmol/L higher', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '6 months prior to Baseline', 'description': 'Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline. Random glucose is a glucose within the last 6 months prior to baseline. The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '928', 'groupId': 'OG000'}, {'value': '1050', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'daily dose ranging from 5-20mcg/day'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'categories': [{'measurements': [{'value': '9.28', 'spread': '7.98', 'groupId': 'OG000'}, {'value': '9.91', 'spread': '8.58', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0107', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.98', 'ciLowerLimit': '0.96', 'ciUpperLimit': '0.99', 'groupDescription': 'Blood glucose self-monitoring - 1 test/week more', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '4 weeks prior to Baseline', 'description': 'Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline. The mean number of self monitoring blood glucose tests per week over the last 4 weeks prior to baseline was determined at baseline and is provided below. The statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).', 'unitOfMeasure': 'tests/week', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.'}, {'type': 'SECONDARY', 'title': 'Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1177', 'groupId': 'OG000'}, {'value': '1315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'daily dose ranging from 5-20mcg/day'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'title': 'Missing', 'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'No', 'categories': [{'measurements': [{'value': '131', 'groupId': 'OG000'}, {'value': '237', 'groupId': 'OG001'}]}]}, {'title': 'Yes', 'categories': [{'measurements': [{'value': '910', 'groupId': 'OG000'}, {'value': '905', 'groupId': 'OG001'}]}]}, {'title': 'Unknown', 'categories': [{'measurements': [{'value': '124', 'groupId': 'OG000'}, {'value': '172', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0193', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.67', 'ciLowerLimit': '1.13', 'ciUpperLimit': '2.46', 'groupDescription': 'Receipt of diet/exercise advice - Yes vs. No', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline', 'description': 'Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline. The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).', 'unitOfMeasure': 'participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.'}, {'type': 'SECONDARY', 'title': 'Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1177', 'groupId': 'OG000'}, {'value': '1315', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'daily dose ranging from 5-20mcg/day'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'categories': [{'measurements': [{'value': '2.82', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '3.00', 'spread': '1.01', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0138', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Odds Ratio (OR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.83', 'ciLowerLimit': '0.72', 'ciUpperLimit': '0.96', 'groupDescription': 'LDL cholesterol - 1 mmol/L higher at baseline', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline. The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All participants who provided consent to release information, fulfilled the study entry criteria, and had a start date provided were included in the analyses.'}, {'type': 'SECONDARY', 'title': 'Changes in HbA1c From Baseline to Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '795', 'groupId': 'OG000'}, {'value': '924', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20 mcg'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.03', 'spread': '1.48', 'groupId': 'OG000'}, {'value': '-1.71', 'spread': '1.82', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 24', 'description': 'Changes in HbA1c From Baseline to Month 24', 'unitOfMeasure': 'percentage of total hemoglobin', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.\n\nAll patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '959', 'groupId': 'OG000'}, {'value': '1170', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20 mcg'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'categories': [{'measurements': [{'value': '26.9', 'groupId': 'OG000'}, {'value': '28.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 24', 'description': 'Percentage of Patients Achieving HbA1c Concentration \\<7.0% at Month 24. Only patients with baseline HbA1c \\>= 7.0 % were included in this analysis', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.\n\nAll patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1019', 'groupId': 'OG000'}, {'value': '1208', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20 mcg'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'categories': [{'measurements': [{'value': '12.5', 'groupId': 'OG000'}, {'value': '10.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 24', 'description': 'Percentage of Patients Achieving HbA1c Concentration \\<6.5% at Month 24. Note: Only patients with baseline HbA1c \\>=6.5% were included in this analysis.', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.\n\nAll patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.'}, {'type': 'SECONDARY', 'title': 'Changes in Weight From Baseline to Month 24', 'denoms': [{'units': 'Participants', 'counts': [{'value': '810', 'groupId': 'OG000'}, {'value': '945', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20 mcg'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'categories': [{'measurements': [{'value': '-3.22', 'spread': '7.93', 'groupId': 'OG000'}, {'value': '2.16', 'spread': '6.24', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 24', 'description': 'Changes in Weight From Baseline to Month 24', 'unitOfMeasure': 'kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.\n\nAll patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.'}, {'type': 'SECONDARY', 'title': 'Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1114', 'groupId': 'OG000'}, {'value': '1274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20 mcg'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'categories': [{'measurements': [{'value': '29.4', 'groupId': 'OG000'}, {'value': '5.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 24', 'description': 'Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.\n\nAll patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.'}, {'type': 'SECONDARY', 'title': 'Incidence of Hypoglycemia Between Baseline and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1114', 'groupId': 'OG000'}, {'value': '1274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20 mcg'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'categories': [{'measurements': [{'value': '17.5', 'groupId': 'OG000'}, {'value': '35.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 24', 'description': 'Incidence of Hypoglycemia between Baseline and 24 Months', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.\n\nAll patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.'}, {'type': 'SECONDARY', 'title': 'Reasons for Discontinuation of Baseline Regimen', 'denoms': [{'units': 'Participants', 'counts': [{'value': '393', 'groupId': 'OG000'}, {'value': '155', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20 mcg'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'title': 'Inadequate response', 'categories': [{'measurements': [{'value': '170', 'groupId': 'OG000'}, {'value': '87', 'groupId': 'OG001'}]}]}, {'title': 'Adverse event', 'categories': [{'measurements': [{'value': '91', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}, {'title': 'Patient decision', 'categories': [{'measurements': [{'value': '69', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}]}, {'title': 'Non compliance', 'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': 'Cannot afford medication', 'categories': [{'measurements': [{'value': '4', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '50', 'groupId': 'OG000'}, {'value': '38', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 24', 'description': 'Reasons for Discontinuation of Baseline Regimen', 'unitOfMeasure': 'number of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.\n\nAll patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.'}, {'type': 'SECONDARY', 'title': 'Factors Associated With Treatment Change in Insulin Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1180', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Insulin Cohort', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'title': 'HbA1c (%) at baseline', 'categories': [{'measurements': [{'value': '1.118', 'groupId': 'OG000', 'lowerLimit': '1.062', 'upperLimit': '1.177'}]}]}, {'title': 'DHP barriers to activity subscale at baseline', 'categories': [{'measurements': [{'value': '0.960', 'groupId': 'OG000', 'lowerLimit': '0.937', 'upperLimit': '0.985'}]}]}, {'title': 'Gastrointestinal symptoms: yes vs. no at baseline', 'categories': [{'measurements': [{'value': '2.532', 'groupId': 'OG000', 'lowerLimit': '1.698', 'upperLimit': '3.777'}]}]}, {'title': 'Insulin regimen: basal/bolus vs. long-acting only', 'categories': [{'measurements': [{'value': '0.437', 'groupId': 'OG000', 'lowerLimit': '0.303', 'upperLimit': '0.630'}]}]}, {'title': 'Insulin regimen: mixtures vs. long-acting only', 'categories': [{'measurements': [{'value': '0.676', 'groupId': 'OG000', 'lowerLimit': '0.523', 'upperLimit': '0.874'}]}]}, {'title': 'Insulin regimen: other vs. long-acting only', 'categories': [{'measurements': [{'value': '0.549', 'groupId': 'OG000', 'lowerLimit': '0.175', 'upperLimit': '1.718'}]}]}, {'title': 'Insulin regimen: short-acting only vs. long-actin', 'categories': [{'measurements': [{'value': '2.164', 'groupId': 'OG000', 'lowerLimit': '1.681', 'upperLimit': '2.785'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.118', 'ciLowerLimit': '1.062', 'ciUpperLimit': '1.177', 'groupDescription': 'HbA1c (%) at baseline', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.001', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.960', 'ciLowerLimit': '0.937', 'ciUpperLimit': '0.985', 'groupDescription': 'DHP barriers to activity subscale at baseline', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.532', 'ciLowerLimit': '1.698', 'ciUpperLimit': '3.777', 'groupDescription': 'Gastrointestinal symptoms: yes vs. no at baseline', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.437', 'ciLowerLimit': '0.303', 'ciUpperLimit': '0.630', 'groupDescription': 'Insulin regimen: basal/bolus vs. long-acting only', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.003', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.676', 'ciLowerLimit': '0.523', 'ciUpperLimit': '0.874', 'groupDescription': 'Insulin regimen: mixtures vs. long-acting only', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.303', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.549', 'ciLowerLimit': '0.175', 'ciUpperLimit': '1.718', 'groupDescription': 'Insulin regimen: other vs. long-acting only', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '<0.001', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '2.164', 'ciLowerLimit': '1.681', 'ciUpperLimit': '2.785', 'groupDescription': 'Insulin regimen: short-acting only vs. long-acting only', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 24', 'description': 'Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort', 'unitOfMeasure': 'hazard ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.\n\nAll patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.'}, {'type': 'SECONDARY', 'title': 'Factors Associated With Treatment Change in Exenatide BID Cohort', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1019', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20 mcg'}], 'classes': [{'title': 'Gastro intestinal symptoms: yes vs no at baseline', 'categories': [{'measurements': [{'value': '1.463', 'groupId': 'OG000', 'lowerLimit': '1.043', 'upperLimit': '2.053'}]}]}, {'title': 'EQ-5D index value at baseline', 'categories': [{'measurements': [{'value': '0.601', 'groupId': 'OG000', 'lowerLimit': '0.432', 'upperLimit': '0.834'}]}]}], 'analyses': [{'pValue': '0.028', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '1.463', 'ciLowerLimit': '1.043', 'ciUpperLimit': '2.053', 'groupDescription': 'GI symptoms: yes vs. no at baseline', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}, {'pValue': '0.002', 'groupIds': ['OG000'], 'paramType': 'Hazard Ratio (HR)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '0.601', 'ciLowerLimit': '0.432', 'ciUpperLimit': '0.834', 'groupDescription': 'EQ-5D index value at baseline', 'statisticalMethod': 'Regression, Cox', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 24', 'description': 'Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort. EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998).', 'unitOfMeasure': 'hazard ratio', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.\n\nAll patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1114', 'groupId': 'OG000'}, {'value': '1274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20 mcg'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'title': 'Last 6 months prior to baseline', 'categories': [{'measurements': [{'value': '94.4', 'groupId': 'OG000'}, {'value': '94.1', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 24 months', 'categories': [{'measurements': [{'value': '90.4', 'groupId': 'OG000'}, {'value': '92.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 24', 'description': 'Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.\n\nAll patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.'}, {'type': 'SECONDARY', 'title': 'Number of Contacts With Health Care Providers Between Baseline and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1114', 'groupId': 'OG000'}, {'value': '1274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20 mcg'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'title': 'Last 6 months prior to baseline', 'categories': [{'measurements': [{'value': '7.17', 'spread': '6.92', 'groupId': 'OG000'}, {'value': '7.64', 'spread': '8.51', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 24 months', 'categories': [{'measurements': [{'value': '19.00', 'spread': '18.20', 'groupId': 'OG000'}, {'value': '24.58', 'spread': '32.75', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to Month 24', 'description': 'Number of contacts with Health Care Providers Between Baseline and 24 Months', 'unitOfMeasure': 'number of contacts', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.\n\nAll patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.'}, {'type': 'SECONDARY', 'title': 'Percentage of Patients Hospitalized Between Baseline and 24 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '1114', 'groupId': 'OG000'}, {'value': '1274', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20 mcg'}, {'id': 'OG001', 'title': 'Insulin', 'description': 'insulin at a dose selected by the HCP and patient'}], 'classes': [{'title': 'Last 6 months prior to baseline', 'categories': [{'measurements': [{'value': '4.7', 'groupId': 'OG000'}, {'value': '6.4', 'groupId': 'OG001'}]}]}, {'title': 'Baseline to 24 months', 'categories': [{'measurements': [{'value': '4.3', 'groupId': 'OG000'}, {'value': '7.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to Month 24', 'description': 'Percentage of Patients Hospitalized Between Baseline and 24 Months', 'unitOfMeasure': 'percentage of patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline, and analyses were conducted irrespective of later treatment changes.\n\nAll patients who provided consent to release information and who fulfilled study entry criteria were included in this analysis population.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20 mcg'}, {'id': 'FG001', 'title': 'Insulin', 'description': 'Insulin at a dose selected by the health care provided (HCP) and patient'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'This population consists of the analysis population.', 'groupId': 'FG000', 'numSubjects': '1114'}, {'comment': 'This population consists of the analysis population.', 'groupId': 'FG001', 'numSubjects': '1274'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'This population consists of patients that completed the 24 month study.', 'groupId': 'FG000', 'numSubjects': '835'}, {'comment': 'This population consists of patients that completed the 24 month study.', 'groupId': 'FG001', 'numSubjects': '992'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '279'}, {'groupId': 'FG001', 'numSubjects': '282'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '12'}, {'groupId': 'FG001', 'numSubjects': '40'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '151'}, {'groupId': 'FG001', 'numSubjects': '172'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'Sponsor decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '82'}, {'groupId': 'FG001', 'numSubjects': '45'}]}]}], 'recruitmentDetails': 'This observational study was conducted at 322 study centers in 6 countries (Belgium, Denmark, France, Germany, Greece, Sweden).\n\nDate of first patient enrolled: 25 January 2008 Date of last patient completed: 01 December 2011', 'preAssignmentDetails': '2515 patients enrolled. 2388 patients in final analysis (22 not in either cohort), excluded: 92 had no investigator signature on summary page, 11 had no treatment start date, 2 had issues with their informed consent to release their data.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '1114', 'groupId': 'BG000'}, {'value': '1274', 'groupId': 'BG001'}, {'value': '2388', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exenatide BID', 'description': 'Daily dose ranging from 5-20 ug'}, {'id': 'BG001', 'title': 'Insulin', 'description': 'Insulin at a dose selected by the HCP and patient'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '58.1', 'spread': '10.1', 'groupId': 'BG000'}, {'value': '63.7', 'spread': '10.9', 'groupId': 'BG001'}, {'value': '61.1', 'spread': '10.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '516', 'groupId': 'BG000'}, {'value': '541', 'groupId': 'BG001'}, {'value': '1057', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '598', 'groupId': 'BG000'}, {'value': '733', 'groupId': 'BG001'}, {'value': '1331', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'France', 'categories': [{'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '84', 'groupId': 'BG001'}, {'value': '252', 'groupId': 'BG002'}]}]}, {'title': 'Greece', 'categories': [{'measurements': [{'value': '319', 'groupId': 'BG000'}, {'value': '488', 'groupId': 'BG001'}, {'value': '807', 'groupId': 'BG002'}]}]}, {'title': 'Denmark', 'categories': [{'measurements': [{'value': '43', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '59', 'groupId': 'BG002'}]}]}, {'title': 'Germany', 'categories': [{'measurements': [{'value': '384', 'groupId': 'BG000'}, {'value': '438', 'groupId': 'BG001'}, {'value': '822', 'groupId': 'BG002'}]}]}, {'title': 'Sweden', 'categories': [{'measurements': [{'value': '84', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '169', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'categories': [{'measurements': [{'value': '116', 'groupId': 'BG000'}, {'value': '163', 'groupId': 'BG001'}, {'value': '279', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Glycosylated hemoglobin (HbA1c)', 'classes': [{'categories': [{'measurements': [{'value': '8.4', 'spread': '1.4', 'groupId': 'BG000'}, {'value': '9.2', 'spread': '1.9', 'groupId': 'BG001'}, {'value': '8.8', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'percentage of total hemoglobin', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Weight', 'classes': [{'categories': [{'measurements': [{'value': '101.2', 'spread': '21.8', 'groupId': 'BG000'}, {'value': '84.2', 'spread': '17.6', 'groupId': 'BG001'}, {'value': '92.1', 'spread': '21.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Body Mass Index (BMI)', 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '6.6', 'groupId': 'BG000'}, {'value': '29.7', 'spread': '5.4', 'groupId': 'BG001'}, {'value': '32.3', 'spread': '6.6', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m2', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Duration of Diabetes', 'classes': [{'categories': [{'measurements': [{'value': '8.2', 'spread': '5.7', 'groupId': 'BG000'}, {'value': '9.8', 'spread': '7.3', 'groupId': 'BG001'}, {'value': '9.1', 'spread': '6.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Concomitant Oral Anti-Diabetic Medication', 'classes': [{'title': 'No OAD', 'categories': [{'measurements': [{'value': '50', 'groupId': 'BG000'}, {'value': '154', 'groupId': 'BG001'}, {'value': '204', 'groupId': 'BG002'}]}]}, {'title': 'Single OAD', 'categories': [{'measurements': [{'value': '383', 'groupId': 'BG000'}, {'value': '476', 'groupId': 'BG001'}, {'value': '859', 'groupId': 'BG002'}]}]}, {'title': 'Combination of 2 OADs', 'categories': [{'measurements': [{'value': '552', 'groupId': 'BG000'}, {'value': '523', 'groupId': 'BG001'}, {'value': '1075', 'groupId': 'BG002'}]}]}, {'title': 'Combination of 3 OADs', 'categories': [{'measurements': [{'value': '118', 'groupId': 'BG000'}, {'value': '112', 'groupId': 'BG001'}, {'value': '230', 'groupId': 'BG002'}]}]}, {'title': 'Combination of 4 OADs', 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'description': 'Number of patients on oral antidiabetic (OAD) medication at baseline. No differentiation possible if patients who did not report OADs actually took no OADs or just did not report them.', 'unitOfMeasure': 'Number of Patients'}], 'populationDescription': 'Analysis population description: all patients who provided consent to release information and who fulfill the study entry criteria were included in the analyses. Patients were assigned to the exenatide BID or insulin cohort based on their initial injectable treatment started at baseline.'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2515}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-03-20', 'studyFirstSubmitDate': '2008-02-20', 'resultsFirstSubmitDate': '2013-07-31', 'studyFirstSubmitQcDate': '2008-03-12', 'lastUpdatePostDateStruct': {'date': '2015-04-09', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2014-06-06', 'studyFirstPostDateStruct': {'date': '2008-03-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2014-07-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Estimates of Probability to Remain on Initial Injectable Treatment at 12 and 24 Months.', 'timeFrame': 'Month 24', 'description': 'The primary objective of this study is to estimate the time spent on initial treatment regime before significant treatment change for patients with type 2 diabetes initiating therapy with either insulin or exenatide for the first time.\n\nInitial treatment regime is defined as the treatment regime prescribed when the patient is enrolled in the study.\n\nSignificant treatment change for patients initiated on insulin or exenatide is defined as at least one of the following:\n\nInsulin:\n\n* Addition of a new medication for the treatment of type 2 diabetes\n* A change in the number of times insulin is administered per day\n* Discontinuation of any insulin initiated at baseline\n* Substitution of a human insulin for an analogue insulin or vice-versa.\n* Switching between brands of the same class/type of insulin is not included in the definition of significant treatment change.\n\nExenatide:\n\n* Addition of a new medication for the treatment of type 2 diabetes\n* Discontinuation of exenatide.'}], 'secondaryOutcomes': [{'measure': 'Higher Body Mass Index (BMI) Associated With Treatment Choice at Baseline', 'timeFrame': 'Baseline', 'description': 'Higher BMI was one of the Factors evaluated for association with treatment choice at baseline. BMI was calculated as body weight in kilograms (kg) divided by height in meters (m) squared (kg/m\\^2). The mean BMI at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for BMI=1 kg/m\\^2 higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).'}, {'measure': 'Higher Hemoglobin A1c (HbA1) Associated With Treatment Choice at Baseline', 'timeFrame': 'Baseline', 'description': 'Higher HbA1c was one of the Factors evaluated for association with treatment choice at baseline.HbA1c was reported in percent of hemoglobin. The mean HbA1c at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for HbA1c=1% higher.'}, {'measure': 'Older Age Associated With Treatment Choice at Baseline', 'timeFrame': 'Baseline', 'description': 'Older age (1 year older) was one of the Factors evaluated for association with treatment choice at baseline. The mean age at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for age 1 year older. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).'}, {'measure': 'Disinhibited Eating Associated With Treatment Choice at Baseline', 'timeFrame': 'Baseline', 'description': 'Diabetes Health Profile (DHP-18) - consists of 18 items across 3 domains (psychological distress, barriers to activity, and disinhibited eating), with each item standardized score rated from 0-100; 0=no dysfunction, higher numbers=greater dysfunction. The subscale of disinhibited eating was one of the Factors evaluated for association with treatment choice at baseline. The number of participants with disinhibited eating at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for disinhibited eating. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).'}, {'measure': 'Higher Random Glucose Associated With Treatment Choice at Baseline', 'timeFrame': '6 months prior to Baseline', 'description': 'Random Glucose 1 millimole per liter (mmol/L) higher was one of the Factors evaluated for association with treatment choice at baseline. Random glucose is a glucose within the last 6 months prior to baseline. The mean is provided below and the statistical analysis provides the 2 arms odds ratio for the glucose 1 mmol/L higher. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).'}, {'measure': 'Frequent Blood Glucose Self Monitoring Associated With Treatment Choice at Baseline', 'timeFrame': '4 weeks prior to Baseline', 'description': 'Frequent glucose self-testing (1 test/week more) was one of the Factors evaluated for association with treatment choice at baseline. The mean number of self monitoring blood glucose tests per week over the last 4 weeks prior to baseline was determined at baseline and is provided below. The statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).'}, {'measure': 'Diet and Exercise Advice in Diabetes Management Associated With Treatment Choice at Baseline', 'timeFrame': 'Baseline', 'description': 'Receipt of diet and exercise advice was one of the Factors evaluated for association with treatment choice at baseline. The number of participants who checked yes or no during the baseline visit for prior receipt of diet/exercise advice in his/her Diabetes management is provided below and the statistical analysis provides the 2 arms odds ratio. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).'}, {'measure': 'Higher Value of Low Density Lipoprotein Cholesterol Associated With Treatment Choice at Baseline', 'timeFrame': 'Baseline', 'description': 'Higher (1 mmol/L higher) LDL cholesterol was one of the Factors evaluated for association with treatment choice at baseline. The mean LDL cholesterol at baseline is provided below and the statistical analysis provides the 2 arms odds ratio for 1 mmol/L higher at baseline. Participants were assigned to the exenatide BID or insulin cohort based the injectable treatment started at baseline; analyses were conducted irrespective of later treatment changes. Baseline was Visit T1 (prior to start of treatment).'}, {'measure': 'Changes in HbA1c From Baseline to Month 24', 'timeFrame': 'Baseline, Month 24', 'description': 'Changes in HbA1c From Baseline to Month 24'}, {'measure': 'Percentage of Patients Achieving HbA1c Concentration <7.0% at Month 24', 'timeFrame': 'Month 24', 'description': 'Percentage of Patients Achieving HbA1c Concentration \\<7.0% at Month 24. Only patients with baseline HbA1c \\>= 7.0 % were included in this analysis'}, {'measure': 'Percentage of Patients Achieving HbA1c Concentration <6.5% at Month 24', 'timeFrame': 'Month 24', 'description': 'Percentage of Patients Achieving HbA1c Concentration \\<6.5% at Month 24. Note: Only patients with baseline HbA1c \\>=6.5% were included in this analysis.'}, {'measure': 'Changes in Weight From Baseline to Month 24', 'timeFrame': 'Baseline, Month 24', 'description': 'Changes in Weight From Baseline to Month 24'}, {'measure': 'Incidence of Gastro Intestinal Symptoms Between Baseline and 24 Months', 'timeFrame': 'Baseline to Month 24', 'description': 'Incidence of Gastro Intestinal Symptoms between Baseline and 24 Months'}, {'measure': 'Incidence of Hypoglycemia Between Baseline and 24 Months', 'timeFrame': 'Baseline to Month 24', 'description': 'Incidence of Hypoglycemia between Baseline and 24 Months'}, {'measure': 'Reasons for Discontinuation of Baseline Regimen', 'timeFrame': 'Baseline to Month 24', 'description': 'Reasons for Discontinuation of Baseline Regimen'}, {'measure': 'Factors Associated With Treatment Change in Insulin Cohort', 'timeFrame': 'Baseline to Month 24', 'description': 'Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Insulin cohort'}, {'measure': 'Factors Associated With Treatment Change in Exenatide BID Cohort', 'timeFrame': 'Baseline to Month 24', 'description': 'Hazards ratios from Backward Cox Regression Model for time to significant treatment change in Exenatide BID cohort. EQ-5D (Health Questionnaire Copyright @ Euro QoL Group 1998).'}, {'measure': 'Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months', 'timeFrame': 'Baseline to Month 24', 'description': 'Percentage of Patients Contacting Health Care Providers Between Baseline and 24 Months'}, {'measure': 'Number of Contacts With Health Care Providers Between Baseline and 24 Months', 'timeFrame': 'Baseline to Month 24', 'description': 'Number of contacts with Health Care Providers Between Baseline and 24 Months'}, {'measure': 'Percentage of Patients Hospitalized Between Baseline and 24 Months', 'timeFrame': 'Baseline to Month 24', 'description': 'Percentage of Patients Hospitalized Between Baseline and 24 Months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'insulin', 'exenatide', 'Byetta', 'Amylin', 'Lilly'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '33049248', 'type': 'DERIVED', 'citation': 'Schultheis P, Montoya MN, Zhao Q, Archer J, Madden T, Peipert JF. Contraception and ectopic pregnancy risk: a prospective observational analysis. Am J Obstet Gynecol. 2021 Feb;224(2):228-229. doi: 10.1016/j.ajog.2020.10.013. Epub 2020 Oct 10. No abstract available.'}, {'pmid': '24369764', 'type': 'DERIVED', 'citation': 'Reaney M, Mathieu C, Ostenson CG, Matthaei S, Krarup T, Kiljanski J, Salaun-Martin C, Sapin H, Theodorakis M, Guerci B. Patient-reported outcomes among patients using exenatide twice daily or insulin in clinical practice in six European countries: the CHOICE prospective observational study. Health Qual Life Outcomes. 2013 Dec 26;11:217. doi: 10.1186/1477-7525-11-217.'}], 'seeAlsoLinks': [{'url': 'http://www.lillytrials.com/', 'label': 'Lilly Clinical Trial Registry'}]}, 'descriptionModule': {'briefSummary': 'Patients initiating injectable therapy for type 2 diabetes (insulin or exenatide) in usual clinical practice will be enrolled and followed up for two years in order to describe actual practice with regards to the time on initial treatment regime, whether treatment regimens are being modified, what treatment modifications are made, and clinical and patient-reported outcomes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'The study population consisted of patients aged 18 or above, with type 2 diabetes starting any of the available initial injectable treatment options (any insulin, or exenatide BID) for the treatment of type 2 diabetes as part of routine clinical care.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* are aged 18 or above\n* diagnosed with type 2 diabetes\n* have had a treatment decision made within the normal course of care to initiate either insulin or exenatide for the treatment of type 2 diabetes\n* have not previously been treated with either insulin or exenatide\n* are not simultaneously participating in another study which includes an investigational drug or procedure at study entry\n* have been fully informed and given their written consent for use of their data\n* have sufficient understanding of the primary language of their country such that they will be able to complete the questionnaires.'}, 'identificationModule': {'nctId': 'NCT00635492', 'briefTitle': 'CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'CHOICE: CHanges to Treatment and Outcomes in Patients With Type 2 Diabetes Initiating InjeCtablE Therapy - A European Observational Study of Patients With Type 2 Diabetes Initiating Injectable Therapy to Determine Time to Treatment Change, Factors Associated With Treatment Changes and Outcomes Over 24 Months', 'orgStudyIdInfo': {'id': 'H8O-EW-B005'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'exenatide', 'interventionNames': ['Drug: exenatide']}, {'label': '2', 'description': 'insulin', 'interventionNames': ['Drug: any human insulin or analog insulin(s) given in any regimen by subcutaneous injection']}], 'interventions': [{'name': 'exenatide', 'type': 'DRUG', 'otherNames': ['Byetta'], 'description': 'subcutaneous injection, 5mcg or 10mcg, twice a day', 'armGroupLabels': ['1']}, {'name': 'any human insulin or analog insulin(s) given in any regimen by subcutaneous injection', 'type': 'DRUG', 'armGroupLabels': ['2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Amager', 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