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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide | Experimental | Placebo lead-in; exenatide 5 mcg for 4 weeks; exenatide 10 mcg for 12 weeks |
|
| Placebo | Placebo Comparator | Placebo in volume equal to exenatide |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | subcutaneous injection, 5mcg or 10mcg, twice a day for 16 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| To test the hypothesis that exenatide (before morning and evening meals) produces a greater decrease in HbA1c than placebo in patients with type 2 diabetes and inadequate glycemic control taking metformin alone or metformin and sulfonylureas. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| To compare exenatide and placebo groups with respect to: *safety and tolerability; *proportion of patients achieving HbA1c<=7%; *body weight; *incidence and rate of hypoglycemic events; *glucose measurements | 16 weeks |
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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 | Beijing | China | ||||
| 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. | |
| 19019476 | Derived |
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| Placebo | Drug | subcutaneous injection twice daily in volumes equal to exenatide |
|
| Guangzhou |
| China |
| Research Site | Nanjing | China |
| Research Site | Shanghai | China |
| Research Site | Sichuan | China |
| Research Site | Chennai | India |
| Research Site | Mumbai | India |
| Research Site | Pune | India |
| Research Site | Seoul | South Korea |
| Research Site | Sungnam City | South Korea |
| Research Site | Chiayi City | Taiwan |
| Research Site | Taichung | Taiwan |
| Research Site | Tainan | Taiwan |
| Research Site | Taipei | Taiwan |
| Gao Y, Yoon KH, Chuang LM, Mohan V, Ning G, Shah S, Jang HC, Wu TJ, Johns D, Northrup J, Brodows R. Efficacy and safety of exenatide in patients of Asian descent with type 2 diabetes inadequately controlled with metformin or metformin and a sulphonylurea. Diabetes Res Clin Pract. 2009 Jan;83(1):69-76. doi: 10.1016/j.diabres.2008.09.037. Epub 2008 Nov 18. |
| 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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