Status:
COMPLETED
Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Novo Nordisk A/S
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
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 detem...
Detailed Description
The investigators will test the hypothesis that effects of liraglutide plus insulin detemir on myocardial fuel selection will be greater than the effects of either agent alone. 27 Type 2 diabetic subj...
Eligibility Criteria
Inclusion
- Type 2 diabetic
- 18-50 years
- BMI \> 25kg/m2
- HbA1c 7.0-10.0%
- Treated with up to 2 oral agents
Exclusion
- Chronic illness or infection (other than diabetes mellitus)
- Known coronary artery disease, structural heart disease or abnormal ECG on screen.
- Treatment with \>2 antihypertensive agents or blood pressure \>140/95 on two occasions during screening
- History of claustrophobia, musculoskeletal or other factors which would result in an inability to comfortably remain within the PET scanner gantry for the duration of the imaging protocol.
- Occupational, investigational or other known radiation exposure which together with the planned radiologic studies, will result in greater than 500 mrem total exposure in a 12 month period.
- Current pregnancy
- Treatment with GLP-1 agonist or DPP4 inhibitor within the past 6 months
- Known intolerance to GLP-1 agonist
- Personal history of pancreatitis, personal or family history of medullary thyroid carcinoma, or other contraindications to liraglutide treatment.
- Recognized microvascular complications (neuropathy, nephropathy, retinopathy).
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 8 2017
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT01232946
Start Date
January 1 2012
End Date
September 8 2017
Last Update
August 7 2019
Active Locations (1)
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1
Indiana Clinical Research Center
Indianapolis, Indiana, United States, 46202