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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A1 - Placebo 0.04 mL twice daily | Placebo Comparator |
| |
| A2 - Placebo 0.04 mL once daily | Placebo Comparator |
| |
| A3 - Placebo 0.08 mL once daily | Placebo Comparator |
| |
| B - Exenatide 10 mcg twice daily | Experimental |
| |
| C - Exenatide 10 mcg once daily | Experimental |
| |
| D - Exenatide 20 mcg once daily | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo 0.04 mL twice daily | Drug | Subcutaneously injected, 0.04 mL, twice daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Day 28 | Change in HbA1c from Baseline Visit 3 (Day 1) to study termination (Day 28) | Baseline, Day 28 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum fructosamine concentration from Baseline to Day 14 and to Day 28 | Change in serum fructosamine concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28) | Baseline, Day 14, Day 28 |
| Change in body weight from Baseline to Day 14 and to Day 28 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Whittier Institute for Diabetes | La Jolla | California | 92037 | United States | ||
| VA Medical Center |
| 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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| Placebo 0.04 mL once daily | Drug | Subcutaneously injected, 0.04 mL, once daily |
|
| Placebo 0.08 mL once daily | Drug | Subcutaneously injected, 0.08 mL, once daily |
|
| B - Exenatide 10 mcg twice daily | Drug | Subcutaneously injected, 10 mcg (0.04 mL), twice daily |
|
|
| C - Exenatide 10 mcg once daily | Drug | Subcutaneously injected, 10 mcg (0.04 mL), once daily |
|
|
| Exenatide 20 mcg once daily | Drug | Subcutaneously injected, 20 mcg (0.08 mL), once daily |
|
|
Change in body weight from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28) |
| Baseline, Day 14, Day28 |
| Change in fasting plasma glucose concentration from Baseline to Day 14 and to Day 28 | Change in fasting plasma glucose concentration from Baseline Visit 3 (Day 1) to Visit 4 (Day 14) and to study termination (Day 28) | Baseline, Day 14, Day 28 |
| Change in postprandial blood glucose concentrations from Baseline to Day 28 | Change in postprandial blood glucose concentrations from Baseline Visit 3 (Day 1) to study termination (Day 28) | Baseline, Week 28 |
| San Diego |
| California |
| 92161 |
| United States |
| MedStar Research Institute | Washington D.C. | District of Columbia | 20003 | United States |
| Internal Medicine Associates, Department of Research | Fort Myers | Florida | 33901 | United States |
| Jacksonville Center for Clinical Research | Jacksonville | Florida | 32216 | United States |
| Innovative Research of West Florida | Largo | Florida | 33770 | United States |
| Henry Ford Health System | Detroit | Michigan | 48202 | United States |
| Grand Rapids Associated Internists | Grand Rapids | Michigan | 49506 | United States |
| Radiant Research, Inc. | St Louis | Missouri | 63141 | United States |
| Internal Medicine Associates | Bozeman | Montana | 59715 | United States |
| Mercury Street Medical Group | Butte | Montana | 59701 | United States |
| Lovelace Scientific Resources | Las Vegas | Nevada | 89128 | United States |
| Rochester Clinical Research, Inc. | Rochester | New York | 14609 | United States |
| Metrolina Medical Research | Charlotte | North Carolina | 28209 | United States |
| Piedmont Medical Research Associates | Winston-Salem | North Carolina | 27103 | United States |
| Radiant Research | Columbus | Ohio | 43212 | United States |
| Smith Clinic Research | Marion | Ohio | 43302 | United States |
| Radiant Research | Portland | Oregon | 97239 | United States |
| Philadelphia Health Associates - Adult Medicine | Philadelphia | Pennsylvania | 19146 | United States |
| Diabetes and Glandular Disease Research Associates | San Antonio | Texas | 78229-4801 | United States |
| S.A.M. Clinical Research Center | San Antonio | Texas | 78229 | United States |
| McGuire VA Medical Center | Richmond | Virginia | 23249 | United States |
| Rockwood Clinic | Spokane | Washington | 99202 | United States |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| ID | Term |
|---|---|
| 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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