Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2026-03-17 @ 3:50 AM
Study NCT ID:
NCT00044694
Status:
COMPLETED
Last Update Posted:
2015-02-20
First Post:
2002-09-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients 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'}], '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': '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': 156}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2002-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-02-19', 'studyFirstSubmitDate': '2002-09-03', 'studyFirstSubmitQcDate': '2002-09-04', 'lastUpdatePostDateStruct': {'date': '2015-02-20', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-09-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28', 'timeFrame': 'Baseline (Day 1) to Day 28', 'description': 'Change in HbA1c from Baseline (Day 1) to study termination (Day 28)'}], 'secondaryOutcomes': [{'measure': 'Change in HbA1c from Baseline to Day 14', 'timeFrame': 'Baseline, Day 14', 'description': 'Change in HbA1c from Baseline (Day 1) to Day 14'}, {'measure': 'Change in fasting plasma glucose from Baseline to Day 14 and to Day 28', 'timeFrame': 'Baseline, Day 14, Day28', 'description': 'Change in fasting plasma glucose from Baseline (Day 1) to Day 14 and to study termination (Day 28)'}, {'measure': 'Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28', 'timeFrame': 'Baseline, Day 14, Day 28', 'description': 'Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus, Type 2'], 'conditions': ['Diabetes Mellitus, Non-Insulin-Dependent']}, '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': 'This is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of AC2993 as compared to placebo in patients with type 2 diabetes. Patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. Patients whose diabetes management consists of diet and exercise will also be eligible for this study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects with type 2 diabetes\n* Treated with diet and exercise alone or with metformin for at least 3 months prior to screening\n* BMI 27-45 kg/m\\^2\n* HbA1c between 7.0 % and 8.0 %\n\nExclusion Criteria:\n\n* Treated with other oral anti-diabetic agents other than metformin within 3 months of screening\n* Patients previously treated with AC2993\n* Patients presently treated with insulin'}, 'identificationModule': {'nctId': 'NCT00044694', 'briefTitle': 'Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 2, Randomized, Triple-Blind, Placebo-Controlled, Short-Term, Dose-Response Study to Examine the Effect on Glucose Control and Safety and Tolerability of AC2993 Given Two Times a Day in Subjects With Type 2 Diabetes Mellitus', 'orgStudyIdInfo': {'id': '2993-116'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 0.01 mL', 'description': '2 week placebo lead-in followed by Placebo 0.01 mL', 'interventionNames': ['Drug: Placebo 0.01 mL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 0.02 mL', 'description': '2 week placebo lead-in followed by Placebo 0.02 mL', 'interventionNames': ['Drug: Placebo 0.02 mL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 0.03 mL', 'description': '2 week placebo lead-in followed by Placebo 0.03 mL', 'interventionNames': ['Drug: Placebo 0.03 mL']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo 0.04 mL', 'description': '2 week placebo lead-in followed by Placebo 0.04 mL', 'interventionNames': ['Drug: Placebo 0.04 mL']}, {'type': 'EXPERIMENTAL', 'label': 'AC2993 2.5 mcg', 'description': '2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL', 'interventionNames': ['Drug: AC2993 2.5 mcg']}, {'type': 'EXPERIMENTAL', 'label': 'AC2993 5.0 mcg', 'description': '2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL', 'interventionNames': ['Drug: AC2993 5.0 mcg']}, {'type': 'EXPERIMENTAL', 'label': 'AC2993 7.5 mcg', 'description': '2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL', 'interventionNames': ['Drug: AC2993 7.5 mcg']}, {'type': 'EXPERIMENTAL', 'label': 'AC2993 10.0 mcg', 'description': '2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL', 'interventionNames': ['Drug: AC2993 10.0 mcg']}], 'interventions': [{'name': 'Placebo 0.01 mL', 'type': 'DRUG', 'description': '2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily', 'armGroupLabels': ['Placebo 0.01 mL']}, {'name': 'Placebo 0.02 mL', 'type': 'DRUG', 'description': '2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily', 'armGroupLabels': ['Placebo 0.02 mL']}, {'name': 'Placebo 0.03 mL', 'type': 'DRUG', 'description': '2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily', 'armGroupLabels': ['Placebo 0.03 mL']}, {'name': 'Placebo 0.04 mL', 'type': 'DRUG', 'description': '2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily', 'armGroupLabels': ['Placebo 0.04 mL']}, {'name': 'AC2993 2.5 mcg', 'type': 'DRUG', 'otherNames': ['synthetic exendin-4'], 'description': '2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 2.5 mcg (0.01 mL) subcutaneously injected twice daily', 'armGroupLabels': ['AC2993 2.5 mcg']}, {'name': 'AC2993 5.0 mcg', 'type': 'DRUG', 'otherNames': ['synthetic exendin-4'], 'description': '2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 5.0 mcg (0.02 mL) subcutaneously injected twice daily', 'armGroupLabels': ['AC2993 5.0 mcg']}, {'name': 'AC2993 7.5 mcg', 'type': 'DRUG', 'otherNames': ['synthetic exendin-4'], 'description': '2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 7.5 mcg (0.03 mL) subcutaneously injected twice daily', 'armGroupLabels': ['AC2993 7.5 mcg']}, {'name': 'AC2993 10.0 mcg', 'type': 'DRUG', 'otherNames': ['synthetic exendin-4'], 'description': '2-week placebo lead-in period (0.01 mL) followed by 4 weeks of AC2993 10.0 mcg (0.04 mL) subcutaneously injected twice daily', 'armGroupLabels': ['AC2993 10.0 mcg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Innovative Clinical Trials', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '35243', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Healthsouth Clinical Research', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '92801', 'city': 'Anaheim', 'state': 'California', 'country': 'United States', 'facility': 'Endocrinology Clinic of O.C.', 'geoPoint': {'lat': 33.83529, 'lon': -117.9145}}, {'zip': '90706', 'city': 'Bellflower', 'state': 'California', 'country': 'United States', 'facility': 'Pioneer Medical Group', 'geoPoint': {'lat': 33.88168, 'lon': -118.11701}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'International Clinical Research Network', 'geoPoint': {'lat': 32.64005, 'lon': -117.0842}}, {'zip': '93721', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Bautista Research and Medical Clinic', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'Whittier Institute for Diabetes', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '95032', 'city': 'Los Gatos', 'state': 'California', 'country': 'United States', 'facility': 'Richard Cherlin, M.D.', 'geoPoint': {'lat': 37.22661, 'lon': -121.97468}}, {'zip': '92553', 'city': 'Moreno Valley', 'state': 'California', 'country': 'United States', 'facility': 'Dr. Martinez Medical Clinic', 'geoPoint': {'lat': 33.93752, 'lon': -117.23059}}, {'zip': '80010', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Anshutz Outpatient Pavilion', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '33760', 'city': 'Clearwater', 'state': 'Florida', 'country': 'United States', 'facility': 'Diagnostic Clinic', 'geoPoint': {'lat': 27.96585, 'lon': -82.8001}}, {'zip': '32605', 'city': 'Gainsville', 'state': 'Florida', 'country': 'United States', 'facility': 'Radiant Research-Gainsville'}, {'zip': '32216', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'facility': 'Jacksonville Center for Clinical Research', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}, {'zip': '33781', 'city': 'Pinellas Park', 'state': 'Florida', 'country': 'United States', 'facility': 'Radiant Research-Pinellas Park', 'geoPoint': {'lat': 27.8428, 'lon': -82.69954}}, {'zip': '30512', 'city': 'Blairsville', 'state': 'Georgia', 'country': 'United States', 'facility': 'Clinical Research Group of North Georgia', 'geoPoint': {'lat': 34.8762, 'lon': -83.95824}}, {'zip': '96813', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'East-West Medical Research Institute', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '96814', 'city': 'Honolulu', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Radiant Research-Honolulu', 'geoPoint': {'lat': 21.30694, 'lon': -157.85833}}, {'zip': '83704', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'Radiant Research-Boise', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '60607', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Cedar-Crosse Research Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '70433', 'city': 'Covington', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Northshore Medical Research, LLC', 'geoPoint': {'lat': 30.47549, 'lon': -90.10042}}, {'zip': '70458', 'city': 'Slidell', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Medical Research Institute', 'geoPoint': {'lat': 30.27519, 'lon': -89.78117}}, {'zip': '01742', 'city': 'Concord', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Melvin Kramer, MD', 'geoPoint': {'lat': 42.46037, 'lon': -71.34895}}, {'zip': '55435', 'city': 'Edina', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Radiant Research-Edina', 'geoPoint': {'lat': 44.88969, 'lon': -93.34995}}, {'zip': '39501', 'city': 'Gulfport', 'state': 'Mississippi', 'country': 'United States', 'facility': 'Mississippi Medical Research, LLC', 'geoPoint': {'lat': 30.36742, 'lon': -89.09282}}, {'zip': '64114', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'The Center for Pharmaceutical Research', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '89119', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Innovative Health Research', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '27511', 'city': 'Cary', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Advanced Research', 'geoPoint': {'lat': 35.79154, 'lon': -78.78112}}, {'zip': '43537', 'city': 'Maumee', 'state': 'Ohio', 'country': 'United States', 'facility': 'Fallen Timbers Internal Medicine, LLC', 'geoPoint': {'lat': 41.56283, 'lon': -83.65382}}, {'zip': '76126', 'city': 'Benbrook', 'state': 'Texas', 'country': 'United States', 'facility': 'Millenium Research', 'geoPoint': {'lat': 32.67319, 'lon': -97.46058}}, {'zip': '75115', 'city': 'DeSoto', 'state': 'Texas', 'country': 'United States', 'facility': 'Healthsouth Clinical Research', 'geoPoint': {'lat': 32.58986, 'lon': -96.85695}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Baylor College of Medicine/Clinical Studies Unit', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '79705', 'city': 'Midland', 'state': 'Texas', 'country': 'United States', 'facility': 'Diabetes Center of the Southwest', 'geoPoint': {'lat': 31.99735, 'lon': -102.07791}}, {'zip': '84108', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'Utah Diabetes Center at the University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}