Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake
1 other identifier
interventional
30
1 country
1
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 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable type-2-diabetes
Started Jan 2012
Longer than P75 for not_applicable type-2-diabetes
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2010
CompletedFirst Posted
Study publicly available on registry
November 2, 2010
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2017
CompletedResults Posted
Study results publicly available
August 7, 2019
CompletedAugust 7, 2019
August 1, 2019
5.7 years
November 1, 2010
February 18, 2019
August 5, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Myocardial Glucose Uptake
PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
3 months
Myocardial Fatty Acid Oxidation Rate
PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
3 months
Myocardial Fatty Acid Esterification Rate
PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir
3 months
Study Arms (3)
Iiraglutide
EXPERIMENTALType 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.
insulin detemir
EXPERIMENTALType 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.
Liraglutide plus insulin detemir
EXPERIMENTALType 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.
Interventions
5units subcutaneous bid titrated to fasting glucose of \<130mg/dL for 3 months
liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \<130mg/dL for 3 months.
Eligibility Criteria
You may qualify if:
- Type 2 diabetic
- years
- BMI \> 25kg/m2
- HbA1c 7.0-10.0%
- Treated with up to 2 oral agents
You may not qualify if:
- 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indiana Universitylead
- Novo Nordisk A/Scollaborator
Study Sites (1)
Indiana Clinical Research Center
Indianapolis, Indiana, 46202, United States
Related Publications (1)
Mather KJ, Considine RV, Hamilton L, Patel NA, Mathias C, Territo W, Goodwill AG, Tune JD, Green MA, Hutchins GD. Combination GLP-1 and Insulin Treatment Fails to Alter Myocardial Fuel Selection vs. Insulin Alone in Type 2 Diabetes. J Clin Endocrinol Metab. 2018 Sep 1;103(9):3456-3465. doi: 10.1210/jc.2018-00712.
PMID: 30020461DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Kieren J. Mather MD
- Organization
- Indiana University
Study Officials
- PRINCIPAL INVESTIGATOR
Kieren J Mather, MD
Indiana University
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor of Medicine
Study Record Dates
First Submitted
November 1, 2010
First Posted
November 2, 2010
Study Start
January 1, 2012
Primary Completion
September 8, 2017
Study Completion
September 8, 2017
Last Updated
August 7, 2019
Results First Posted
August 7, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share