Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake

This study is currently recruiting participants.
Verified April 2013 by Indiana University
Sponsor:
Collaborator:
Novo Nordisk A/S
Information provided by (Responsible Party):
Indiana University
ClinicalTrials.gov Identifier:
NCT01232946
First received: November 1, 2010
Last updated: April 17, 2013
Last verified: April 2013
  Purpose

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).


Condition Intervention
Type 2 Diabetes
Drug: liraglutide
Drug: insulin detemir
Drug: liraglutide plus insulin detemir

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Official Title: Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • myocardial glucose uptake [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir


Estimated Enrollment: 27
Study Start Date: January 2012
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Iiraglutide
Type II 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.
Drug: liraglutide
1.8mg subcutaneous qd for 3 months
Other Name: Vyctoza
Experimental: insulin detemir
Type II 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.
Drug: insulin detemir
5units subcutaneous bid titrated to fasting glucose of <130mg/dL for 3 months
Other Name: Levemir
Experimental: Combination treatment
Type II 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.
Drug: liraglutide plus insulin detemir
liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose <130mg/dL for 3 months.
Other Name: Vyctoza plus Levemir

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type II 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).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01232946

Locations
United States, Indiana
Indiana Clinical Research Center Recruiting
Indianapolis, Indiana, United States, 46202
Contact: Robin L Chisholm, RN    317-274-7679    rlchisho@iupui.edu   
Principal Investigator: Kieren J Mather, MD         
Sponsors and Collaborators
Indiana University
Novo Nordisk A/S
Investigators
Principal Investigator: Kieren J Mather, MD Indiana University
  More Information

No publications provided

Responsible Party: Indiana University
ClinicalTrials.gov Identifier: NCT01232946     History of Changes
Other Study ID Numbers: 1105005578
Study First Received: November 1, 2010
Last Updated: April 17, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Indiana University:
Diabetes
Myocardial metabolism

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Insulin, Long-Acting
Glucagon-Like Peptide 1
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Incretins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on April 22, 2014