Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake
Part of paid clinical trials in Indianapolis, Indiana.
- Sponsor
- Indiana University
- Study ID
- NCT01232946
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 50 Years
- Healthy Volunteers
- Not accepted
Interventions
- liraglutide — DRUG1.8mg subcutaneous qd for 3 months
- insulin detemir — DRUG5units subcutaneous bid titrated to fasting glucose of \<130mg/dL for 3 months
- liraglutide plus insulin detemir — DRUGliraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \<130mg/dL for 3 months.
Study Details
27 Type 2 diabetic subjects (HbA1c 7.5 - 9.5%) currently treated with diet and exercise alone or with oral antidiabetic agents will be randomly assigned to one of three treatment groups: insulin detemir, liraglutide, or liraglutide plus detemir (9 subjects per group), on a background of metformin 2000 mg per day. After 3 months' treatment, PET measurements of myocardial fuel selection will take place, under fasting conditions in the morning following that day's treatment injection(s).
Key Dates
- Start date
- Jan 31, 2012
- Status verified
- Aug 2019
- Primary completion
- Sep 8, 2017
- Completion
- Sep 8, 2017
Study Design
- Enrollment
- 30 participants (actual)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- OTHER
Arms
- Experimental: IiraglutideType 2 diabetic subjects will be assigned to 3 months of treatment with 1.8mg liraglutide administered once daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
- Experimental: insulin detemirType 2 diabetic subjects will be assigned to 3 months of treatment with insulin detemir administered twice daily in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
- Experimental: Liraglutide plus insulin detemirType 2 diabetic subjects will be assigned to 3 months of treatment with a combination of liraglutide and insulin detemir in addition to background metformin 2000mg/day. PET measurements of myocardial glucose uptake will take place at the end of treatment.
Primary Outcome Measure
Myocardial Glucose Uptake [ Time Frame: 3 months ]
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Indiana Clinical Research Center | Indianapolis | Indiana | 46202 | - |
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