Clinical Trial Details
| Trial ID: | L3282 |
| Source ID: | NCT01181986 |
| Associated Drug: | Exenatide Sc |
| Title: | The Study of Exenatide Action on Vessel Function in Type 2 Diabetes and Prediabetes |
| Acronym: | |
| Status: | COMPLETED |
| Study Results: | YES |
| Results: | https://ClinicalTrials.gov/show/NCT01181986/results |
| Conditions: | Type 2 Diabetes Mellitus |
| Interventions: | DRUG: Exenatide SC|DRUG: Exenatide IV|DRUG: Placebo SC|DRUG: Exendin-9|DRUG: Placebo IV |
| Outcome Measures: | Primary: Reactive Hyperemia Index (RHI), Greater RHI reflects greater endothelial function. It is calculated as average post-ischemia pulse magnitude divided by average pre-ischemia pulse magnitude. Results are expressed as least-square means of ANCOVA models., 0, 2, 4, 6 and 8 hours on Day 11 (Sub-study 1); 0 and 120 minutes on test Days 1, 2 & 3 (Sub-study 2) | Secondary: Plasma Triglycerides, Triglycerides concentrations were measured before and 2, 4, 6 and 8 hours following study drug. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence., 0, 2, 4, 6 and 8 hours post-study drug on day 11|Plasma Glucose, Plasma glucose was measured before and 2, 4, 6 and 8 hours following study drug administration. Results are expressed as least-square means of ANCOVA models adjusted for sampling time and intervention sequence., 0, 2, 4, 6, and 8 hours post-study drug on day 11 |
| Sponsor/Collaborators: | Sponsor: Carl T. Hayden VA Medical Center | Collaborators: American Diabetes Association|Amylin Pharmaceuticals, LLC. |
| Gender: | ALL |
| Age: | ADULT, OLDER_ADULT |
| Phases: | PHASE4 |
| Enrollment: | 76 |
| Study Type: | INTERVENTIONAL |
| Study Designs: | Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: BASIC_SCIENCE |
| Start Date: | 2010-08 |
| Completion Date: | 2012-12 |
| Results First Posted: | 2014-04-28 |
| Last Update Posted: | 2014-05-20 |
| Locations: | Phoenix VA Medical Center, Phoenix, Arizona, 85012, United States |
| URL: | https://clinicaltrials.gov/show/NCT01181986 |
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