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 — DRUG
    1.8mg subcutaneous qd for 3 months
  • insulin detemir — DRUG
    5units subcutaneous bid titrated to fasting glucose of \<130mg/dL for 3 months
  • liraglutide plus insulin detemir — DRUG
    liraglutide 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: Iiraglutide
    Type 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 detemir
    Type 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 detemir
    Type 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)

FacilityCityStateZIPSite coordinators
Indiana Clinical Research CenterIndianapolisIndiana46202-

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