Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2026-01-01 @ 8:24 PM
Study NCT ID:
NCT00085969
Status:
COMPLETED
Last Update Posted:
2015-02-23
First Post:
2004-06-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus
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': 99}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-19', 'studyFirstSubmitDate': '2004-06-18', 'studyFirstSubmitQcDate': '2004-06-21', 'lastUpdatePostDateStruct': {'date': '2015-02-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28', 'timeFrame': 'Baseline, Day 28', 'description': 'Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28)'}], 'secondaryOutcomes': [{'measure': 'Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28', 'timeFrame': 'Baseline, Day 14, Day 28', 'description': 'Change in serum fructosamine concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)'}, {'measure': 'Change in body weight from Baseline to Day 14 and to Day 28', 'timeFrame': 'Baseline, Day 14, Day28', 'description': 'Change in body weight from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)'}, {'measure': 'Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28', 'timeFrame': 'Baseline, Day 14, Day 28', 'description': 'Change in fasting plasma glucose concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)'}, {'measure': 'Change in postprandial blood glucose concentrations from Baseline to Day 28', 'timeFrame': 'Baseline, Week 28', 'description': 'Change in postprandial blood glucose concentrations from Baseline Visit 3 (Day 1) to study termination (Day 28)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'exenatide', 'Amylin', 'Lilly'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'referencesModule': {'references': [{'pmid': '17705687', 'type': 'DERIVED', 'citation': 'Nelson P, Poon T, Guan X, Schnabel C, Wintle M, Fineman M. The incretin mimetic exenatide as a monotherapy in patients with type 2 diabetes. Diabetes Technol Ther. 2007 Aug;9(4):317-26. doi: 10.1089/dia.2006.0024.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety and efficacy of a 28-day regimen of exenatide (AC2993), given as a monotherapy to subjects 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* Subject has type 2 diabetes mellitus treated with diet and exercise modification alone or in combination with one oral antidiabetic agent for no longer than 4 years.\n\nExclusion Criteria:\n\n* Subject has a clinically significant history or presence of any of the following conditions: (a) Hepatic disease, (b) Renal disease, (c) Central nervous system disease, (d) Gastrointestinal disease (e) Pulmonary disease (f) Hematologic disease.\n* Subject is currently treated with any of the following excluded medications: (a) Metformin/sulfonylurea combination therapy (b) Thiazolidinediones (c) Insulin as outpatient therapy (d) Regular use of drugs that directly affect gastrointestinal motility (e) Regular use of systemic corticosteroids by oral, intravenous (IV), or intramuscular (IM) route, or potent, inhaled, intrapulmonary, or intranasal steroids known to have a high rate of systemic absorption (f) Regular use of medications with addictive potential such as opiates, narcotics and tranquilizers (g) Antineoplastic agents (h) Transplantation medications (i) Prescription weight-loss medications.'}, 'identificationModule': {'nctId': 'NCT00085969', 'briefTitle': 'Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Multicenter Study to Examine the Effect of Exenatide Monotherapy on Glucose Control in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '2993-120'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'A1 - Placebo 0.04 mL twice daily', 'interventionNames': ['Drug: Placebo 0.04 mL twice daily']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'A2 - Placebo 0.04 mL once daily', 'interventionNames': ['Drug: Placebo 0.04 mL once daily']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'A3 - Placebo 0.08 mL once daily', 'interventionNames': ['Drug: Placebo 0.08 mL once daily']}, {'type': 'EXPERIMENTAL', 'label': 'B - Exenatide 10 mcg twice daily', 'interventionNames': ['Drug: B - Exenatide 10 mcg twice daily']}, {'type': 'EXPERIMENTAL', 'label': 'C - Exenatide 10 mcg once daily', 'interventionNames': ['Drug: C - Exenatide 10 mcg once daily']}, {'type': 'EXPERIMENTAL', 'label': 'D - Exenatide 20 mcg once daily', 'interventionNames': ['Drug: Exenatide 20 mcg once daily']}], 'interventions': [{'name': 'Placebo 0.04 mL twice daily', 'type': 'DRUG', 'description': 'Subcutaneously injected, 0.04 mL, twice daily', 'armGroupLabels': ['A1 - Placebo 0.04 mL twice daily']}, {'name': 'Placebo 0.04 mL once daily', 'type': 'DRUG', 'description': 'Subcutaneously injected, 0.04 mL, once daily', 'armGroupLabels': ['A2 - Placebo 0.04 mL once daily']}, {'name': 'Placebo 0.08 mL once daily', 'type': 'DRUG', 'description': 'Subcutaneously injected, 0.08 mL, once daily', 'armGroupLabels': ['A3 - Placebo 0.08 mL once daily']}, {'name': 'B - Exenatide 10 mcg twice daily', 'type': 'DRUG', 'otherNames': ['ACC2993', 'synthetic exendin-4'], 'description': 'Subcutaneously injected, 10 mcg (0.04 mL), twice daily', 'armGroupLabels': ['B - Exenatide 10 mcg twice daily']}, {'name': 'C - Exenatide 10 mcg once daily', 'type': 'DRUG', 'otherNames': ['ACC2993', 'synthetic exendin-4'], 'description': 'Subcutaneously injected, 10 mcg (0.04 mL), once daily', 'armGroupLabels': ['C - Exenatide 10 mcg once daily']}, {'name': 'Exenatide 20 mcg once daily', 'type': 'DRUG', 'otherNames': ['ACC2993', 'synthetic exendin-4'], 'description': 'Subcutaneously injected, 20 mcg (0.08 mL), once daily', 'armGroupLabels': ['D - Exenatide 20 mcg once daily']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'The Whittier Institute for Diabetes', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '92161', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'VA Medical Center', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '20003', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'MedStar Research Institute', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Internal Medicine Associates, Department of Research', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33770', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Innovative Research of West Florida', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '48202', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Henry Ford Health System', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '49506', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Grand Rapids Associated Internists', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Radiant Research, Inc.', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '59715', 'city': 'Bozeman', 'state': 'Montana', 'country': 'United States', 'facility': 'Internal Medicine Associates', 'geoPoint': {'lat': 45.67965, 'lon': -111.03856}}, {'zip': '59701', 'city': 'Butte', 'state': 'Montana', 'country': 'United States', 'facility': 'Mercury Street Medical Group', 'geoPoint': {'lat': 46.00382, 'lon': -112.53474}}, {'zip': '89128', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Lovelace Scientific Resources', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '14609', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Rochester Clinical Research, Inc.', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '28209', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Metrolina Medical Research', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27103', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Piedmont Medical Research Associates', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43212', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '43302', 'city': 'Marion', 'state': 'Ohio', 'country': 'United States', 'facility': 'Smith Clinic Research', 'geoPoint': {'lat': 40.58867, 'lon': -83.12852}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Radiant Research', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '19146', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Philadelphia Health Associates - Adult Medicine', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78229-4801', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Diabetes and Glandular Disease Research Associates', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'S.A.M. Clinical Research Center', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '23249', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'McGuire VA Medical Center', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '99202', 'city': 'Spokane', 'state': 'Washington', 'country': 'United States', 'facility': 'Rockwood Clinic', 'geoPoint': {'lat': 47.65966, 'lon': -117.42908}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Eli Lilly and Company', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}