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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This study will look at the safety of substituting exenatide for insulin in patients with type 2 diabetes who are currently taking insulin and oral antidiabetic agent(s).
This is an exploratory, multicenter, open-label, 2-arm, parallel trial. Approximately 30 patients with type 2 diabetes, currently on a sulfonylurea, or meglitinide and/or metformin and insulin therapy, will be randomized to discontinue insulin and substitute it with exenatide or remain on their current diabetes therapy regimen. All patients will continue their current diet and exercise regimen during the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide | Experimental | The subjects will discontinue their insulin and substitute it with exenatide. Subjects will remain on their existing oral diabetic therapy. |
|
| Insulin | Active Comparator | The subjects will remain on their current insulin therapy. Subjects will also remain on their existing oral diabetic therapy. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | Exenatide 5 mcg subcutaneously injected twice daily for 4 weeks; then 10 mcg subcutaneously injected twice daily for 12 weeks. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in HbA1c (glycosylated hemoglobin) from Baseline to Week 16 | Change in HbA1c from Baseline study termination (Week 16) | Baseline, 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 | Chula Vista | California | 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. | |
| 17595353 | Derived |
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| 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 |
| D007328 | Insulin |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Insulin | Drug | Insulin will be taken according to the subject's current regimen |
|
| Butte |
| Montana |
| United States |
| Research Site | Portland | Oregon | United States |
| Research Site | Nashville | Tennessee | United States |
| Research Site | San Antonio | Texas | United States |
| Davis SN, Johns D, Maggs D, Xu H, Northrup JH, Brodows RG. Exploring the substitution of exenatide for insulin in patients with type 2 diabetes treated with insulin in combination with oral antidiabetes agents. Diabetes Care. 2007 Nov;30(11):2767-72. doi: 10.2337/dc06-2532. Epub 2007 Jun 26. |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |