N/A
Completed N=30
Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake
Source: ClinicalTrials.gov NCT01232946 ↗Enrolled (actual)
30
Serious AEs
0.0%
Results posted
Aug 2019
Primary outcomePrimary: Myocardial Glucose Uptake — 0.055; 0.0399; 0.0373 umol/g/min — p=0.65
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).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Myocardial Glucose Uptake |
0.055; 0.0399; 0.0373 | 0.65 |
| PRIMARY Myocardial Fatty Acid Oxidation Rate |
0.1019; 0.1234; 0.0992 | 0.065 |
| PRIMARY Myocardial Fatty Acid Esterification Rate |
0.00274; 0.00358; 0.00146 | 0.80 |
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT01232946). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.