Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake

• Status: Completed
• Trial end date: 2017-09-08
• Target enrollment: 0
• Participant gender: All

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 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).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Indiana University
• Collaborator: Novo Nordisk A/S
• Treatments: Insulin; Insulin Detemir; Insulin, Globin Zinc; Liraglutide

Criteria

Inclusion Criteria:

• Type 2 diabetic

• 18-50 years

• BMI > 25kg/m2

• HbA1c 7.0-10.0%

• Treated with up to 2 oral agents

Exclusion Criteria:

• 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).