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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo 0.01 mL | Placebo Comparator | 2 week placebo lead-in followed by Placebo 0.01 mL |
|
| Placebo 0.02 mL | Placebo Comparator | 2 week placebo lead-in followed by Placebo 0.02 mL |
|
| Placebo 0.03 mL | Placebo Comparator | 2 week placebo lead-in followed by Placebo 0.03 mL |
|
| Placebo 0.04 mL | Placebo Comparator | 2 week placebo lead-in followed by Placebo 0.04 mL |
|
| AC2993 2.5 mcg | Experimental | 2 week placebo lead-in (0.01 mL) followed by AC2993 2.5 mcg; 0.01 mL |
|
| AC2993 5.0 mcg | Experimental | 2 week placebo lead-in followed by AC2993 5.0 mcg; 0.01 mL |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo 0.01 mL | Drug | 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.01 mL subcutaneously injected twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 | Change in HbA1c from Baseline (Day 1) to study termination (Day 28) | Baseline (Day 1) to Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c from Baseline to Day 14 | Change in HbA1c from Baseline (Day 1) to Day 14 | Baseline, Day 14 |
| Change in fasting plasma glucose from Baseline to Day 14 and to Day 28 | Change in fasting plasma glucose from Baseline (Day 1) to Day 14 and to study termination (Day 28) |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Innovative Clinical Trials | Birmingham | Alabama | 35209 | United States | ||
| Healthsouth Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17705687 | Derived | 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. |
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|
| AC2993 7.5 mcg | Experimental | 2 week placebo lead-in followed by AC2993 7.5 mcg; 0.03 mL |
|
| AC2993 10.0 mcg | Experimental | 2 week placebo lead-in period followed by AC2993 10.0 mcg; 0.04 mL |
|
| Placebo 0.02 mL | Drug | 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.02 mL subcutaneously injected twice daily |
|
| Placebo 0.03 mL | Drug | 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.03 mL subcutaneously injected twice daily |
|
| Placebo 0.04 mL | Drug | 2-week placebo lead-in period (0.01 mL) followed by 4 weeks of Placebo 0.04 mL subcutaneously injected twice daily |
|
| AC2993 2.5 mcg | Drug | 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 |
|
|
| AC2993 5.0 mcg | Drug | 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 |
|
|
| AC2993 7.5 mcg | Drug | 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 |
|
|
| AC2993 10.0 mcg | Drug | 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 |
|
|
| Baseline, Day 14, Day28 |
| Change in serum fructosamine from Baseline (Day 1) to Day 14 and to Day 28 | Change in serum fructosamine from baseline (Day 1) to Visit 4 (Day 14) and to study termination (Day 28) | Baseline, Day 14, Day 28 |
| Birmingham |
| Alabama |
| 35243 |
| United States |
| Endocrinology Clinic of O.C. | Anaheim | California | 92801 | United States |
| Pioneer Medical Group | Bellflower | California | 90706 | United States |
| International Clinical Research Network | Chula Vista | California | 91910 | United States |
| Bautista Research and Medical Clinic | Fresno | California | 93721 | United States |
| Whittier Institute for Diabetes | La Jolla | California | 92037 | United States |
| Richard Cherlin, M.D. | Los Gatos | California | 95032 | United States |
| Dr. Martinez Medical Clinic | Moreno Valley | California | 92553 | United States |
| Anshutz Outpatient Pavilion | Aurora | Colorado | 80010 | United States |
| Diagnostic Clinic | Clearwater | Florida | 33760 | United States |
| Radiant Research-Gainsville | Gainsville | Florida | 32605 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Radiant Research-Pinellas Park | Pinellas Park | Florida | 33781 | United States |
| Clinical Research Group of North Georgia | Blairsville | Georgia | 30512 | United States |
| East-West Medical Research Institute | Honolulu | Hawaii | 96813 | United States |
| Radiant Research-Honolulu | Honolulu | Hawaii | 96814 | United States |
| Radiant Research-Boise | Boise | Idaho | 83704 | United States |
| Cedar-Crosse Research Center | Chicago | Illinois | 60607 | United States |
| Northshore Medical Research, LLC | Covington | Louisiana | 70433 | United States |
| Medical Research Institute | Slidell | Louisiana | 70458 | United States |
| Melvin Kramer, MD | Concord | Massachusetts | 01742 | United States |
| Radiant Research-Edina | Edina | Minnesota | 55435 | United States |
| Mississippi Medical Research, LLC | Gulfport | Mississippi | 39501 | United States |
| The Center for Pharmaceutical Research | Kansas City | Missouri | 64114 | United States |
| Innovative Health Research | Las Vegas | Nevada | 89119 | United States |
| Carolina Advanced Research | Cary | North Carolina | 27511 | United States |
| Fallen Timbers Internal Medicine, LLC | Maumee | Ohio | 43537 | United States |
| Millenium Research | Benbrook | Texas | 76126 | United States |
| Healthsouth Clinical Research | DeSoto | Texas | 75115 | United States |
| Baylor College of Medicine/Clinical Studies Unit | Houston | Texas | 77030 | United States |
| Diabetes Center of the Southwest | Midland | Texas | 79705 | United States |
| Utah Diabetes Center at the University of Utah | Salt Lake City | Utah | 84108 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| ID | Term |
|---|---|
| D000077270 | Exenatide |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
| D014118 | Toxins, Biological |
| D001685 | Biological Factors |
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