Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 10/27/2017 |
| Start Date: | January 2012 |
| End Date: | September 8, 2017 |
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).
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).
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 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). All subjects will
undergo an initial standardization of background treatment to metformin 2000 mg per day,
followed by randomized assignment to 3 months' treatment with liraglutide 1.8 mg/day (once
daily each morning, tapering up according to label instructions) and/or detemir (administered
twice daily, initially at 10 units per day then titrated to achieve fasting morning glucose
readings below 130 mg/dL). PET measurements of myocardial fuel selection will take place at
the end of this treatment period, under fasting conditions in the morning following that
day's treatment injection(s).
on myocardial fuel selection will be greater than the effects of either agent alone. 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). All subjects will
undergo an initial standardization of background treatment to metformin 2000 mg per day,
followed by randomized assignment to 3 months' treatment with liraglutide 1.8 mg/day (once
daily each morning, tapering up according to label instructions) and/or detemir (administered
twice daily, initially at 10 units per day then titrated to achieve fasting morning glucose
readings below 130 mg/dL). PET measurements of myocardial fuel selection will take place at
the end of this treatment period, under fasting conditions in the morning following that
day's treatment injection(s).
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).
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