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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This trial is designed to compare the effects of twice-daily (before lunch and before dinner) exenatide plus oral antidiabetic (OAD) agents and twice-daily (before breakfast and before dinner) exenatide plus OAD with respect to glycemic control (HbA1c) in patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 - exenatide before breakfast and dinner | Experimental |
| |
| 2 - exenatide before lunch and dinner | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | subcutaneous injection, 5mcg or 10mcg, twice a day (before lunch and dinner) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12 | Evaluate the change in glycemic control as measured by HbA1c from Baseline to Week 12 | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in body weight from Baseline to Week 12, and if measured, at each visit | Change in body weight (kg) from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8) | Baseline, Weeks 4, 8, 12 |
| Change in fasting serum glucose (FGS) from Baseline to Week 12, and if measured, at each visit |
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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 | Campinas | Brazil | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18662495 | Derived | Forti A, Garcia EG, Yu MB, Jimenez MC, Brodows RG, Oliveira JH. Efficacy and safety of exenatide administered before the two largest daily meals of Latin American patients with type 2 diabetes. Curr Med Res Opin. 2008 Sep;24(9):2437-47. doi: 10.1185/03007990802282398. Epub 2008 Jul 24. |
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| exenatide | Drug | subcutaneous injection, 5mcg or 10mcg, twice a day (before breakfast and dinner) |
|
|
Change in FGS from Baseline to Week 12, and if measured, at each visit in between (Weeks 4 and 8) |
| Baseline, Weeks 4, 8, 12 |
| Changes in self-monitored blood glucose (SMBG) profile from Baseline through Week 12 | Changes in glucose measured at different times throughout the day derived from 7-point SMBG profile (glucose measurements before and 2 hours after the start of the morning, midday, and evening meals, and at bedtime) | Baseline, Weeks 4, 8, 12 |
| Curitiba |
| Brazil |
| Research Site | Fortaleza | Brazil |
| Research Site | Goiânia | Brazil |
| Research Site | Porto Alegre | Brazil |
| Research Site | Rio de Janeiro | Brazil |
| Research Site | Salvador | Brazil |
| Research Site | São José do Rio Preto | Brazil |
| Research Site | São Paulo | Brazil |
| Research Site | Aguascalientes | Aguascalientes | Mexico |
| Research Site | Guadalajara | Jalisco | Mexico |
| Research Site | Monterrey | Nuevo León | Mexico |
| Research Site | San Luis Potosí City | San Luis Potosí | Mexico |
| Research Site | Mérida | Yucatán | Mexico |
| Research Site | Mexico City | Mexico |
| 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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