Evaluation of the Effect on Glucose Control and the Safety and Tolerability of AC2993 in Patients With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Amylin Pharmaceuticals, LLC.
Information provided by (Responsible Party):
Amylin Pharmaceuticals, LLC.
ClinicalTrials.gov Identifier:
NCT00044694
First received: September 3, 2002
Last updated: February 5, 2013
Last verified: February 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Diabetes Mellitus, Non-Insulin-Dependent |
Drug: Placebo 0.01 mL Drug: Placebo 0.02 mL Drug: Placebo 0.03 mL Drug: Placebo 0.04 mL Drug: AC2993 2.5 mcg Drug: AC2993 5.0 mcg Drug: AC2993 7.5 mcg Drug: AC2993 10.0 mcg |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by Amylin Pharmaceuticals, LLC.:
Primary Outcome Measures:
- Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 [ Time Frame: Baseline (Day 1) to Day 28 ] [ Designated as safety issue: No ]Change in HbA1c from Baseline (Day 1) to study termination (Day 28)
Secondary Outcome Measures:
- Change in HbA1c from Baseline to Day 14 [ Time Frame: Baseline, Day 14 ] [ Designated as safety issue: No ]Change in HbA1c from Baseline (Day 1) to Day 14
- Change in fasting plasma glucose from Baseline to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day28 ] [ Designated as safety issue: No ]Change in fasting plasma glucose from Baseline (Day 1) to Day 14 and to study termination (Day 28)
- Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28 [ Time Frame: Baseline, Day 14, Day 28 ] [ Designated as safety issue: No ]Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and to study termination (Day 28)
| Enrollment: | 156 |
| Study Start Date: | August 2002 |
| Study Completion Date: | May 2003 |
| Primary Completion Date: | May 2003 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Placebo 0.01 mL
2 week placebo lead-in followed by Placebo 0.01 mL
|
Drug: Placebo 0.01 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily
|
|
Placebo Comparator: Placebo 0.02 mL
2 week placebo lead-in followed by Placebo 0.02 mL
|
Drug: Placebo 0.02 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily
|
|
Placebo Comparator: Placebo 0.03 mL
2 week placebo lead-in followed by Placebo 0.03 mL
|
Drug: Placebo 0.03 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily
|
|
Placebo Comparator: Placebo 0.04 mL
2 week placebo lead-in followed by Placebo 0.04 mL
|
Drug: Placebo 0.04 mL
2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily
|
|
Experimental: AC2993 2.5 mcg
2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL
|
Drug: AC2993 2.5 mcg
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
Other Name: synthetic exendin-4
|
|
Experimental: AC2993 5.0 mcg
2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL
|
Drug: AC2993 5.0 mcg
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
Other Name: synthetic exendin-4
|
|
Experimental: AC2993 7.5 mcg
2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL
|
Drug: AC2993 7.5 mcg
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
Other Name: synthetic exendin-4
|
|
Experimental: AC2993 10.0 mcg
2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL
|
Drug: AC2993 10.0 mcg
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
Other Name: synthetic exendin-4
|
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Subjects with type 2 diabetes
- Treated with diet and exercise alone or with metformin for at least 3 months prior to screening
- BMI 27-45 kg/m^2
- HbA1c between 7.0 % and 8.0 %
Exclusion Criteria:
- Treated with other oral anti-diabetic agents other than metformin within 3 months of screening
- Patients previously treated with AC2993
- Patients presently treated with insulin
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00044694
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Hide Study LocationsLocations
| United States, Alabama | |
| Innovative Clinical Trials | |
| Birmingham, Alabama, United States, 35209 | |
| Healthsouth Clinical Research | |
| Birmingham, Alabama, United States, 35243 | |
| United States, California | |
| Endocrinology Clinic of O.C. | |
| Anaheim, California, United States, 92801 | |
| Pioneer Medical Group | |
| Bellflower, California, United States, 90706 | |
| International Clinical Research Network | |
| Chula Vista, California, United States, 91910 | |
| Bautista Research and Medical Clinic | |
| Fresno, California, United States, 93721 | |
| Whittier Institute for Diabetes | |
| La Jolla, California, United States, 92037 | |
| Richard Cherlin, M.D. | |
| Los Gatos, California, United States, 95032 | |
| Dr. Martinez Medical Clinic | |
| Moreno Valley, California, United States, 92553 | |
| United States, Colorado | |
| Anshutz Outpatient Pavilion | |
| Aurora, Colorado, United States, 80010 | |
| United States, Florida | |
| Diagnostic Clinic | |
| Clearwater, Florida, United States, 33760 | |
| Radiant Research-Gainsville | |
| Gainsville, Florida, United States, 32605 | |
| Jacksonville Center for Clinical Research | |
| Jacksonville, Florida, United States, 32216 | |
| Radiant Research-Pinellas Park | |
| Pinellas Park, Florida, United States, 33781 | |
| United States, Georgia | |
| Clinical Research Group of North Georgia | |
| Blairsville, Georgia, United States, 30512 | |
| United States, Hawaii | |
| Radiant Research-Honolulu | |
| Honolulu, Hawaii, United States, 96814 | |
| East-West Medical Research Institute | |
| Honolulu, Hawaii, United States, 96813 | |
| United States, Idaho | |
| Radiant Research-Boise | |
| Boise, Idaho, United States, 83704 | |
| United States, Illinois | |
| Cedar-Crosse Research Center | |
| Chicago, Illinois, United States, 60607 | |
| United States, Louisiana | |
| Northshore Medical Research, LLC | |
| Covington, Louisiana, United States, 70433 | |
| Medical Research Institute | |
| Slidell, Louisiana, United States, 70458 | |
| United States, Massachusetts | |
| Melvin Kramer, MD | |
| Concord, Massachusetts, United States, 01742 | |
| United States, Minnesota | |
| Radiant Research-Edina | |
| Edina, Minnesota, United States, 55435 | |
| United States, Mississippi | |
| Mississippi Medical Research, LLC | |
| Gulfport, Mississippi, United States, 39501 | |
| United States, Missouri | |
| The Center for Pharmaceutical Research | |
| Kansas City, Missouri, United States, 64114 | |
| United States, Nevada | |
| Innovative Health Research | |
| Las Vegas, Nevada, United States, 89119 | |
| United States, North Carolina | |
| Carolina Advanced Research | |
| Cary, North Carolina, United States, 27511 | |
| United States, Ohio | |
| Fallen Timbers Internal Medicine, LLC | |
| Maumee, Ohio, United States, 43537 | |
| United States, Texas | |
| Millenium Research | |
| Benbrook, Texas, United States, 76126 | |
| Healthsouth Clinical Research | |
| Desoto, Texas, United States, 75115 | |
| Baylor College of Medicine/Clinical Studies Unit | |
| Houston, Texas, United States, 77030 | |
| Diabetes Center of the Southwest | |
| Midland, Texas, United States, 79705 | |
| United States, Utah | |
| Utah Diabetes Center at the University of Utah | |
| Salt Lake City, Utah, United States, 84108 | |
Sponsors and Collaborators
Amylin Pharmaceuticals, LLC.
More Information
No publications provided by Amylin Pharmaceuticals, LLC.
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Amylin Pharmaceuticals, LLC. |
| ClinicalTrials.gov Identifier: | NCT00044694 History of Changes |
| Other Study ID Numbers: | 2993-116 |
| Study First Received: | September 3, 2002 |
| Last Updated: | February 5, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Amylin Pharmaceuticals, LLC.:
|
Diabetes Mellitus, Type 2 |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Exenatide Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013