Ignite Creation Date:
2025-12-24 @ 10:10 PM
Ignite Modification Date:
2025-12-29 @ 9:21 AM
Study NCT ID:
NCT00103935
Status:
COMPLETED
Last Update Posted:
2015-02-24
First Post:
2005-02-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], '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'}]}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-23', 'studyFirstSubmitDate': '2005-02-17', 'studyFirstSubmitQcDate': '2005-02-17', 'lastUpdatePostDateStruct': {'date': '2015-02-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-02-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assess the safety, tolerability, and pharmacokinetics of exenatide long-acting release (LAR) administered weekly by subcutaneous (SC) injection in subjects with type 2 diabetes (T2DM)', 'timeFrame': 'Time intervals: 0 min to 12 hours on Day 1 for a duration of 12 hours, from Day 1; 0 mininutes to Week 1 for a duration of 168 hours, and from Week 14 to Week 15 for a duration of 168 hours'}], 'secondaryOutcomes': [{'measure': 'Examine the effect on various pharmacodynamic parameters of exenatide LAR administered weekly by subcutaneous injection in subjects with Type 2 Diabetes Mellitus', 'timeFrame': 'Various time intervals from Day 1 to Week 15'}, {'measure': 'Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27).', 'timeFrame': 'Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27', 'description': 'Change in HbA1c from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination.'}, {'measure': 'Change in fasting glucose concentrations from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)', 'timeFrame': 'Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27', 'description': 'Change in fasting glucose concentrations from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination'}, {'measure': 'Change in body weight from Baseline to Week 15 and to each intermediate visit where applicable, and to study termination (Week 27)', 'timeFrame': 'Day -3, Day 1, Weeks 1, 2, 4, 5, 7, 8, 10, 11, 13, 14, 15, 16, 17, 18, 19, 27', 'description': 'Change in body weight (kg) from baseline Visit 3 (Day -3) to Visit 25 (Week 15) and to each intermediate visit where applicable, and to study termination'}, {'measure': 'Change in seven-point glucose concentrations from Baseline to Week 14 and Week 15', 'timeFrame': 'Baseline, 3 days between Day -7 and Day -3, and 3 days between Week 14 and Week 15', 'description': 'Change in seven-point glucose concentrations from baseline (collected on 3 days between Visit 2 \\[Day -7\\] and Visit 3 \\[Day -3\\]) to Visit 25 (collected on 3 days between Visit 20 \\[Week 14\\] and Visit 25 \\[Week 15\\])'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'exenatide', 'long acting release', 'Amylin', 'Lilly'], 'conditions': ['Type 2 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '21142268', 'type': 'DERIVED', 'citation': 'Fineman M, Flanagan S, Taylor K, Aisporna M, Shen LZ, Mace KF, Walsh B, Diamant M, Cirincione B, Kothare P, Li WI, MacConell L. Pharmacokinetics and pharmacodynamics of exenatide extended-release after single and multiple dosing. Clin Pharmacokinet. 2011 Jan;50(1):65-74. doi: 10.2165/11585880-000000000-00000.'}]}, 'descriptionModule': {'briefSummary': 'Exenatide LAR is a long-acting release formulation of exenatide, which is a twice-daily dosage form currently under investigation as a potential treatment for people with type 2 diabetes mellitus. This study will assess the safety, tolerability, and pharmacokinetics of Exenatide LAR administered weekly by subcutaneous injection in people with type 2 diabetes mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Has type 2 diabetes treated with either: \\*A stable regimen of metformin for a minimum of 3 months, and/or \\*Diet modification and exercise for a minimum of 3 months.\n* Has HbA1c of 7.1% to 11.0%, inclusive.\n* Has a body mass index (BMI) of 25 kg/m2 to 45 kg/m2, inclusive.\n\nExclusion Criteria:\n\n* Received any investigational drug within 3 months prior to screening.\n* Is currently treated with any of the following excluded medications: \\*Thiazolidinediones within 3 months of screening; \\* Sulfonylureas within 3 months of screening; \\* Insulin within 1 year of screening.\n* Participated previously in an exenatide clinical study.'}, 'identificationModule': {'nctId': 'NCT00103935', 'briefTitle': 'Study Examining Exenatide Long-Acting Release in Subjects With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Examine Safety and Pharmacokinetics of Exenatide Long-Acting Release Administered Weekly in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '2993LAR-104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Group A1', 'description': 'Placebo lead-in followed by placebo equivalent volume to 0.8 mg exenatide LAR', 'interventionNames': ['Drug: placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Group A2', 'description': 'Placebo lead-in followed by placebo equivalent volume to 2.0 mg exenatide LAR', 'interventionNames': ['Drug: placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Group B', 'description': 'Exenatide lead-in followed by exenatide LAR 0.8 mg weekly', 'interventionNames': ['Drug: Exenatide LAR']}, {'type': 'EXPERIMENTAL', 'label': 'Group C', 'description': 'Exenatide lead-in followed by exenatide LAR 2.0 mg weekly', 'interventionNames': ['Drug: Exenatide LAR']}], 'interventions': [{'name': 'placebo', 'type': 'DRUG', 'description': 'Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 0.8 mcg', 'armGroupLabels': ['Group A1']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Subcutaneously injected placebo 0.02 mL twice daily as lead-in followed by once weekly injected amount equivalent to exenatide LAR 2.0 mcg', 'armGroupLabels': ['Group A2']}, {'name': 'Exenatide LAR', 'type': 'DRUG', 'otherNames': ['Bydureon'], 'description': 'Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 0.8 mcg.', 'armGroupLabels': ['Group B']}, {'name': 'Exenatide LAR', 'type': 'DRUG', 'otherNames': ['Bydureon'], 'description': 'Subcutaneously injected exenatide 5 mcg (0.02 mL) twice daily as lead-in followed by once weekly injected exenatide LAR 2.0 mcg.', 'armGroupLabels': ['Group C']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'city': 'Olympia', 'state': 'Washington', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 47.04491, 'lon': -122.90169}}], 'overallOfficials': [{'name': 'Lisa Porter, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Amylin Pharmaceuticals, LLC.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}