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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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The purpose of this study is to test the hypothesis that in patients with type 2 diabetes, the addition of exenatide will result in lower time-averaged serum glucose during a 24-hour period, compared with placebo.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exenatide | Experimental | Exenatide and the subject's current oral antidiabetic agent regimen |
|
| Placebo | Placebo Comparator | Placebo and the subject's current oral antidiabetic agent regimen |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exenatide | Drug | subcutaneous injection, 5mcg twice a day for one week; then 10 mcg twice a day for one week |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time-averaged serum glucose during a 24-hour period | Time-averaged serum glucose during a 24-hour period | Every half-hour to hour for 24 hours |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the effects of exenatide and placebo on serum glucose | To compare the effects of exenatide and placebo on serum glucose measured as averaged daytime glucose, averaged nighttime glucose, time-averaged postprandial glucose 2 hours after each meal, time-averaged postprandial glucose 4 hours after each meal, 2-hour postprandial glucose averaged across morning and evening meals, and averaged across the three meals, and fluctuation evaluations |
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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 | Washington D.C. | District of Columbia | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 18394265 | Derived | Brodows RG, Qu Y, Johns D, Kim D, Holcombe JH. Quantifying the effect of exenatide and insulin glargine on postprandial glucose excursions in patients with type 2 diabetes. Curr Med Res Opin. 2008 May;24(5):1395-7. doi: 10.1185/030079908x297268. Epub 2008 Apr 3. |
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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 |
| ID | Term |
|---|---|
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D014688 | Venoms |
| D045424 | Complex Mixtures |
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| Placebo | Drug | subcutaneous injection, equivalent volume to 5 mcg exenatide twice a day for one week; then equivalent volume to 10 mcg exenatide twice a day for one week |
|
| Each half-hour to 2 hours for 24 hours |
| San Antonio |
| Texas |
| United States |
| D014118 |
| Toxins, Biological |
| D001685 | Biological Factors |