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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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This study will be the first evaluation of exenatide in adolescent subjects with type 2 diabetes mellitus and is designed to evaluate the blood levels of the drug (pharmacokinetics), the drug's biochemical and physiological effects (pharmacodynamics), and tolerability of exenatide in these subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 | Experimental | Exenatide 2.5 mcg - Exenatide 5 mcg - Placebo 0.02 mL |
|
| Sequence 2 | Experimental | Exenatide 2.5 mcg - Placebo 0.02 mL - Exenatide 5 mcg |
|
| Sequence 3 | Experimental | Placebo 0.02 mL - Exenatide 2.5 mcg - Exenatide 5 mcg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exenatide - Exenatide - Placebo | Drug | Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose, followed by placebo 0.02 mL, single dose. All are subcutaneous injections. |
| Measure | Description | Time Frame |
|---|---|---|
| To assess the pharmacokinetics of exenatide | To assess pharmacokinetics of exenatide by measuring peak plasma time, time to peak concentration, terminal elimination half-life, apparent elimination time constant, apparent clearance, apparent volume of distribution, and area under concentration curve. | Three day-long (8 hour) assessments over a 5-week period |
| To assess the pharmacodynamics of exenatide | To assess the pharmacodynamics of exenatide by measuring plasma glucose, serum insulin, and plasma glucagon: absolute and incremental area under the curve 0-3 hours), absolute and incremental area under the curve (0-6 hours), areas under the concentration-time curve (0-6 h), peak plasma contration, and time to peak concentration. | Three day-long (8 hour) assessments over a 5-week period |
| Number of adverse events | Adverse events will be assessed at all visits after the Screening Visit [Visit 2 (first time subject is dosed) through Visit 4 (study termination)]. All events assessed with special attention to changes in vital signs, ECGs, and laboratory values | Visit 2 through Visit 4 |
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Inclusion Criteria:
Exclusion Criteria:
Received any investigational drug or has participated in any type of clinical trial within 3 months prior to screening.
Currently participates in any other interventional study.
Is currently treated with any of the following excluded medications:
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| Name | Affiliation | Role |
|---|---|---|
| Lisa Porter, MD | Amylin Pharmaceuticals, LLC. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Little Rock | Arkansas | United States | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19446153 | Derived | Malloy J, Capparelli E, Gottschalk M, Guan X, Kothare P, Fineman M. Pharmacology and tolerability of a single dose of exenatide in adolescent patients with type 2 diabetes mellitus being treated with metformin: a randomized, placebo-controlled, single-blind, dose-escalation, crossover study. Clin Ther. 2009 Apr;31(4):806-15. doi: 10.1016/j.clinthera.2009.04.005. |
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|
| Exenatide - Placebo - Exenatide | Drug | Exenatide 2.5 mcg, single dose, followed by placebo 0.02 mL, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections. |
|
|
| Placebo - Exenatide - Exenatide | Drug | Placebo 0.02 mL, single dose, followed by Exenatide 2.5 mcg, single dose, followed by Exenatide 5 mcg, single dose. All are subcutaneous injections. |
|
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| San Diego |
| California |
| United States |
| Research Site | Denver | Colorado | United States |
| Research Site | Louisville | Kentucky | United States |
| Research Site | San Antonio | Texas | United States |
| 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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