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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This study will examine the response of several doses of LY2148568 (exenatide) and assess the effect on glucose control and safety and tolerability in Japanese patients with type 2 diabetes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide 5 mcg/exenatide 10 mcg | Experimental |
| |
| Exenatide 5 mcg/exenatide 5 mcg | Experimental |
| |
| Exenatide 2.5 mcg/exenatide 2.5 mcg | Experimental |
| |
| Placebo/placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide (LY2148568) | Drug | subcutaneous injection twice daily, 5 mcg for 4 weeks, then 10 mcg for 8 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 12 | Assess dose response effect on glucose control as measured by HbA1c among four doses (2.5 μg, 5 μg, 10 μg, and placebo) of subcutaneous injection of exenatide, twice daily before meals in the morning and evening, for 12 weeks | Baseline, Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects achieving HbA1c <7% at Week 12 | Total number of subjects achieving HbA1c <7% at Week 12 | 12 weeks |
| Changes in fasting blood glucose from Visits 3 to 7 | Changes in fasting blood glucose from Baseline (Visit 3) to Week 12 (Visit 7) |
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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 | Fukuoka | Japan | ||||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19194050 | Result | Kadowaki T, Namba M, Yamamura A, Sowa H, Wolka AM, Brodows RG. Exenatide exhibits dose-dependent effects on glycemic control over 12 weeks in Japanese patients with suboptimally controlled type 2 diabetes. Endocr J. 2009;56(3):415-24. doi: 10.1507/endocrj.k08e-296. Epub 2009 Feb 4. | |
| 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. |
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| exenatide (LY2148568) | Drug | subcutaneous injection twice daily, 5 mcg for 4 weeks, then 5 mcg for 8 weeks |
|
|
| exenatide (LY2148568) | Drug | subcutaneous injection twice daily, 2.5 mcg for 4 weeks, then 2.5 mcg for 8 weeks |
|
|
| Placebo | Drug | subcutaneous injection twice daily, 0.02 mL to 0.04 mL |
|
| Baseline, Week 12 |
| Change in Serum lipids from Baseline to Week 12 | Changes in serum lipids (total cholesterol, LDL cholesterol, HDL cholesterol and triglycerides) from Baseline (Visit 3) to Week 12 (Visit 7) | Baseline, Week 12 |
| Changes in body weight, waist size and waist/hip ratio from Baseline to Week 12 | Changes in body weight, waist size and waist/hip ratio from Baseline (Visit 3) to Week 12 (Visit 7) | Baseline, Week 12 |
| Fukushima |
| Japan |
| Research Site | Gunma | Japan |
| Research Site | Hiroshima | Japan |
| Research Site | Hyōgo | Japan |
| Research Site | Ibaraki | Japan |
| Research Site | Kanagawa | Japan |
| Research Site | Kumamoto | Japan |
| Research Site | Kyoto | Japan |
| Research Site | Nagano | Japan |
| Research Site | Okayama | Japan |
| Research Site | Osaka | Japan |
| Research Site | Ōita | Japan |
| Research Site | Tokyo | Japan |
| 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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