Ignite Creation Date:
2025-12-24 @ 6:42 PM
Ignite Modification Date:
2026-01-17 @ 11:51 AM
Study NCT ID:
NCT02606357
Status:
COMPLETED
Last Update Posted:
2018-10-12
First Post:
2015-11-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069036', 'term': 'Insulin Glargine'}], 'ancestors': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 242}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-11-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-10', 'completionDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-10-11', 'studyFirstSubmitDate': '2015-11-13', 'studyFirstSubmitQcDate': '2015-11-13', 'lastUpdatePostDateStruct': {'date': '2018-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-11-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in HbA1c', 'timeFrame': 'Baseline, 6 months'}], 'secondaryOutcomes': [{'measure': '- Percentage of patients achieving target of HbA1c <7%', 'timeFrame': '6 months'}, {'measure': '- Change from baseline in fasting plasma glucose values', 'timeFrame': 'Baseline, 3 months, and 6 months'}, {'measure': '- Percentage of patients with hypoglycemic events', 'timeFrame': 'Baseline, 6 months'}, {'measure': '- Change from baseline in body weight', 'timeFrame': 'Baseline, 3 months and 6 months'}, {'measure': '- Number of patients with adverse events', 'timeFrame': 'Baseline, 6 months'}, {'measure': '- Change in dose of insulin glargine', 'timeFrame': '3 months and 6 months'}, {'measure': '- Change in the titration doses used (if any)', 'timeFrame': '6 months'}, {'measure': '- Time to reach control', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n-To assess the change in glycosylated hemoglobin (HbA1c) in uncontrolled Type 2 diabetes patients on OAD agent in Jordan after 6 months of treatment with basal insulin (Insulin glargine).\n\nSecondary Objectives:\n\n* To evaluate the percentage of patients achieving target of HbA1c ˂7%.\n* To evaluate the change in fasting plasma glucose (FPG).\n* To assess the following safety criteria: hypoglycemic events, body weight changes, and overall safety.\n* Describe the titration process: changes in glargine insulin dose at 3 months and 6 months, changes in the titration doses used (if any), and time to reach control.', 'detailedDescription': 'The total duration of study period per patient is up to 6 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria :\n\n* Patient ≥ 18 years old.\n* Male or Female.\n* Type 2 diabetes patients.\n* Uncontrolled with previous therapy (HbA1c \\>7%), evident in HbA1c test within the last 1 month before study entry.\n* Insulin naïve patients: any patient uncontrolled after one or a maximum of two lines of therapy including: monotherapy (Metformin alone or any other Oral Anti-Diabetic agent (OAD) if contraindicated or intolerance) and/or dual therapy (any OAD combination), at maximum tolerated dose in the last 3 months.\n* Signed informed consent.\n* Signed informed consent.\n\nExclusion criteria:\n\n* Patient not willing or not able to perform self-monitoring blood glucose.\n* Patient not willing or not able to self-titrate insulin glargine under physician's guidance.\n* Patient not suitable for participation according to what is specified in the approved Summary of Product's Characteristics or according to medical or clinical conditions, as judged by the Investigator.\n* History of impaired hepatic function defined as alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) greater than three times the upper limit of normal, evident in testing done in the last 3 months.\n* History of impaired renal function defined as serum creatinine \\>135 μmol/L (\\>1.525 mg/dL)in men and \\>110 μmol/L (\\>1.243 mg/dL) in women, evident in testing done in the last 3 months.\n* Pregnant or lactating women (women of childbearing potential must have a negative pregnancy test at study entry and a medically approved contraception method at physician's discretion).\n* Treatment with systemic corticosteroid within 3 months prior to study entry.\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT02606357', 'acronym': 'NEWLAN', 'briefTitle': 'Treatment of Type 2 Diabetes With Long Acting Basal Insulin in Jordan', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Treatment Initiation With Basal Insulin in Uncontrolled Type 2 Diabetes Patients on Oral Anti-Diabetic Agent (OAD) in Jordan', 'orgStudyIdInfo': {'id': 'LANTUL07225'}, 'secondaryIdInfos': [{'id': 'U1111-1172-1002', 'type': 'OTHER', 'domain': 'UTN'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HOE901', 'description': 'HOE901 administered subcutaneously once a day in the evening, at dinner, or at bedtime with titration based on FPG levels', 'interventionNames': ['Drug: INSULIN GLARGINE']}], 'interventions': [{'name': 'INSULIN GLARGINE', 'type': 'DRUG', 'otherNames': ['HOE901'], 'description': 'Pharmaceutical form:Solution\n\nRoute of administration: Subcutaneous', 'armGroupLabels': ['HOE901']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Jordan', 'country': 'Jordan', 'facility': 'JORDAN'}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}