Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-01-17 @ 11:10 PM
Study NCT ID:
NCT02638805
Status:
COMPLETED
Last Update Posted:
2018-11-05
First Post:
2015-12-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide
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': 'D008687', 'term': 'Metformin'}, {'id': 'D000069450', 'term': 'Liraglutide'}], 'ancestors': [{'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-11', 'dispFirstSubmitDate': '2018-10-30', 'completionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-11-01', 'studyFirstSubmitDate': '2015-12-18', 'dispFirstSubmitQcDate': '2018-11-01', 'studyFirstSubmitQcDate': '2015-12-18', 'dispFirstPostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'lastUpdatePostDateStruct': {'date': '2018-11-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-12-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change from baseline in blood pressure and heart rate', 'timeFrame': 'from baseline to 34 weeks', 'description': 'Change from baseline in blood pressure and heart rate at Week 26'}, {'measure': 'Change from baseline in fasting plasma glucose', 'timeFrame': 'from baseline to Week 26'}, {'measure': 'Change from baseline in cholesterol', 'timeFrame': 'from baseline to Week 26', 'description': 'Change in low-density lipoprotein cholesterol (LDL-C), and high-density lipoprotein cholesterol (HDL-C)'}], 'primaryOutcomes': [{'measure': 'Number (percentage) and severity of treatment-emergent adverse events (TEAEs) of nausea and/or vomiting', 'timeFrame': 'From Randomization to 34 weeks', 'description': 'Number (percentage) and severity of treatment-emergent AEs (TEAEs) of nausea and/or vomiting over the 26-week treatment period; treatment discontinuation for nausea and/or vomiting; and pattern of nausea and/or vomiting over time.'}], 'secondaryOutcomes': [{'measure': 'Number (percentage) and severity of all treatment-emergent adverse events', 'timeFrame': 'From Randomization to 34 weeks', 'description': 'All TEAEs 2 dose regimens of ITCA 650 over 26 weeks in patients with T2D after switching from stable therapy with liraglutide'}, {'measure': 'Incidence of hypoglycemia', 'timeFrame': 'From Randomization to 34 weeks'}, {'measure': 'Change in percentage of glycosylated hemoglobin (HbA1c) in the blood', 'timeFrame': 'From baseline to Week 26'}, {'measure': 'Change in body weight', 'timeFrame': 'from baseline to Week 26', 'description': 'Change from baseline in body weight at Week 26'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'A Phase 3b, open-label, randomized, multicenter, safety and tolerability study of ITCA 650 in subjects with Type 2 diabetes taking liraglutide and metformin.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diagnosis of type 2 diabetes ≥ 3 months.\n* Stable regimen of diet and exercise in combination with a stable treatment of liraglutide ≥1.2 mg/day and metformin ≥1000 mg/day.\n* HbA1c ≤9.5%.\n* Stable body weight ≥ 3 months.\n* Body mass index (BMI) ≥25 to ≤45 kg per meter squared.\n* Calcitonin \\<50 ng/L (50 pg/mL) at the Screening Visit.\n\nExclusion Criteria:\n\n* History of type 1 diabetes.\n* Recent use or of anti-diabetic medications other than liraglutide or metformin.\n* History of significant/severe nausea and/or vomiting due to liraglutide.\n* Significant symptomatic hyperglycemia.\n* History or evidence, within the last 6 months prior to the Screening Visit, of myocardial infarction, coronary revascularization (coronary artery bypass grafting or percutaneous coronary intervention), unstable angina, or cerebrovascular accident or stroke.\n* History or evidence of acute or chronic pancreatitis.\n* History of liver disease.\n* History of medullary thyroid cancer or a family or personal history of multiple endocrine neoplasia type 2.\n* Poor thyroid, liver, or renal function.\n* Serum creatinine levels \\>1.5mg/dL (132 μmol/L) for male patients, or \\>1.4 mg/dL (123 μmol/L) for female patients.\n* Weight loss surgery or requires weight loss medications.\n* History of malignancy (not including basal or squamous cell carcinoma of the skin with past 5 years).\n* History of active alcohol or substance abuse.\n* Treatment with medications that affect GI motility.\n* History of hypersensitivity to exenatide or liraglutide.\n* Women that are pregnant, lactating, or planning to become pregnant.'}, 'identificationModule': {'nctId': 'NCT02638805', 'briefTitle': 'Study of the Safety and Tolerability of Switching to ITCA 650 in Patients With Type 2 Diabetes Receiving Liraglutide', 'organization': {'class': 'INDUSTRY', 'fullName': 'Intarcia Therapeutics'}, 'officialTitle': 'An Open-Label, Multi-Center, Randomized, Phase 3b Study to Evaluate the Safety and Tolerability of Switching to One of Two Dosing Strategies of ITCA 650 in Patients With Type 2 Diabetes Receiving Stable Doses of Liraglutide', 'orgStudyIdInfo': {'id': 'ITCA 650-CLP-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group 1', 'description': 'ITCA 650 20/60 mcg/day', 'interventionNames': ['Drug: ITCA 650 Osmotic Mini Pump 20/60 mcg/day', 'Drug: Metformin', 'Drug: Liraglutide']}, {'type': 'EXPERIMENTAL', 'label': 'Group 2', 'description': 'ITCA 650 60 mcg/day', 'interventionNames': ['Drug: ITCA 650 Osmotic Mini Pump 60 mcg/day', 'Drug: Metformin', 'Drug: Liraglutide']}], 'interventions': [{'name': 'ITCA 650 Osmotic Mini Pump 20/60 mcg/day', 'type': 'DRUG', 'description': 'ITCA 650 osmotic mini pump delivering exenatide 20/60 mcg/day', 'armGroupLabels': ['Group 1']}, {'name': 'ITCA 650 Osmotic Mini Pump 60 mcg/day', 'type': 'DRUG', 'description': 'ITCA 650 osmotic mini pump delivering exenatide 60 mcg/day', 'armGroupLabels': ['Group 2']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Stable dose for at least 3 months (at least 1000 mg/day)', 'armGroupLabels': ['Group 1', 'Group 2']}, {'name': 'Liraglutide', 'type': 'DRUG', 'description': 'Stable dose for at least 3 months (at least 1.2 mg/day)', 'armGroupLabels': ['Group 1', 'Group 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35235', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Alabama Clinical Therapeutics, LLC', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '36542', 'city': 'Gulf Shores', 'state': 'Alabama', 'country': 'United States', 'facility': "Saint Vincent's Medical Center (BRANY)", 'geoPoint': {'lat': 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