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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This study is designed to compare the effects of twice-daily exenatide plus oral antidiabetic (OAD) agents and twice-daily placebo plus OAD with respect to glycemic control, as measured by hemoglobin A1c (HbA1c), in patients with type 2 diabetes who experience inadequate glycemic control with OAD alone.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide | Experimental | After a 2-week placebo lead-in period, exenatide will be given in an esclating dose along with the subject's current therapy regimen |
|
| Placebo | Placebo Comparator | After a 2-week placebo lead-in period, subjects will be given placebo (in equivalent amounts to exenatide) in addition to their current therapy regimen. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer 20 mcg of exenatide (2 units [5 μg] ), twice daily by subcutaneous injection, for the first 4 weeks of therapy, and then 40 μL of study drug (4 units [10 μg] of exenatide) twice daily by subcutaneous injection, for the remaining 12 weeks of therapy. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16, and if measured, any visits in between | Change in HbA1c from Baseline (Visit 3) to study termination at Week 16, and at all study visits in between | Baseline, Week 4, Week 8, Week 12, Week 16 |
| Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose | Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime) | Baseline, Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of subjects reaching the target HbA1c (<7%) | The percentage of subjects reaching the target HbA1c (<7%) will be summarized and compared by treatment | Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 |
| Change in body weight from Baseline to Week 16 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| James Malone, MD | Eli Lilly and Company | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Birmingham | Alabama | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22236356 | Derived | Fineman MS, Mace KF, Diamant M, Darsow T, Cirincione BB, Booker Porter TK, Kinninger LA, Trautmann ME. Clinical relevance of anti-exenatide antibodies: safety, efficacy and cross-reactivity with long-term treatment. Diabetes Obes Metab. 2012 Jun;14(6):546-54. doi: 10.1111/j.1463-1326.2012.01561.x. Epub 2012 Feb 10. | |
| 17404349 | Derived |
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|
|
| Placebo | Drug | After a 2-week placebo lead-in period (twice daily, given subcutaneously) in addition to their current therapy regimen, subjects will administer placebo (in equivalent amounts to exenatide) for 16 weeks of therapy. |
|
Change in body weight (kg) from Baseline to Week 16 |
| Baseline, Week 16 |
| Change from Baseline to Week 16 in fasting serum glucose (FSG) and glucose | Change from Baseline to Week 16 in FSG and glucose measured at different times throughout the day derived from 7-point self-monitored glucose (SMG) profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime) | Baseline, Week 16 |
| Changes in beta cell function and insulin sensitivity between Baseline and Week 16 | Changes in beta cell function and insulin sensitivity as assessed by homeostasis model assessment (HOMA) analyses and the proinsulin/insulin ratio Between Baseline and Week 16 | Baseline, Week 16 |
| Changes in lipids between Baseline and Week 16 | Changes from Baseline to Week 16 in serum lipids (total cholesterol [TC], high-density lipoprotein cholesterol [HDL-C], fasting triglycerides, calculated low-density lipoprotein cholesterol [LDL-C] | Baseline, Week 16 |
| La Jolla |
| California |
| United States |
| Research Site | San Mateo | California | United States |
| Research Site | Santa Barbara | California | United States |
| Research Site | Spring Valley | California | United States |
| Research Site | Hialeah | Florida | United States |
| Research Site | Jacksonville | Florida | United States |
| Research Site | Melbourne | Florida | United States |
| Research Site | West Palm Beach | Florida | United States |
| Research Site | Atlanta | Georgia | United States |
| Research Site | Honolulu | Hawaii | United States |
| Research Site | Idaho Falls | Idaho | United States |
| Research Site | Chicago | Illinois | United States |
| Research Site | Baton Rouge | Louisiana | United States |
| Research Site | Kalamazoo | Michigan | United States |
| Research Site | Troy | Michigan | United States |
| Research Site | Butte | Montana | United States |
| Research Site | McCook | Nebraska | United States |
| Research Site | North Platte | Nebraska | United States |
| Research Site | Omaha | Nebraska | United States |
| Research Site | Scottsbluff | Nebraska | United States |
| Research Site | Princeton | New Jersey | United States |
| Research Site | Albuquerque | New Mexico | United States |
| Research Site | Albany | New York | United States |
| Research Site | New York | New York | United States |
| Research Site | Rochester | New York | United States |
| Research Site | Greenville | North Carolina | United States |
| Research Site | Cleveland | Ohio | United States |
| Research Site | Greenville | South Carolina | United States |
| Research Site | Chattanooga | Tennessee | United States |
| Research Site | Knoxville | Tennessee | United States |
| Research Site | Dallas | Texas | United States |
| Research Site | Georgetown | Texas | United States |
| Research Site | San Antonio | Texas | United States |
| Research Site | The Colony | Texas | United States |
| Research Site | Olympia | Washington | United States |
| Research Site | Renton | Washington | United States |
| Research Site | Tacoma | Washington | United States |
| Research Site | Charleston | West Virginia | United States |
| Research Site | Huntington | West Virginia | United States |
| Research Site | Calgary | Alberta | Canada |
| Research Site | Vancouver | British Columbia | Canada |
| Research Site | Dartmouth | Nova Scotia | Canada |
| Research Site | London | Ontario | Canada |
| Research Site | Toronto | Ontario | Canada |
| Research Site | Montreal | Quebec | Canada |
| Research Site | Granada | Spain |
| Research Site | Seville | Spain |
| Research Site | Valencia | Spain |
| Research Site | Valladolid | Spain |
| Research Site | Zaragoza | Spain |
| Zinman B, Hoogwerf BJ, Duran Garcia S, Milton DR, Giaconia JM, Kim DD, Trautmann ME, Brodows RG. The effect of adding exenatide to a thiazolidinedione in suboptimally controlled type 2 diabetes: a randomized trial. Ann Intern Med. 2007 Apr 3;146(7):477-85. doi: 10.7326/0003-4819-146-7-200704030-00003. |
| 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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