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Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake

This study is currently recruiting participants. (see Contacts and Locations)
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

November 1, 2010
April 17, 2013
January 2012
December 2015   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01232946 on ClinicalTrials.gov Archive Site
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Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake
Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake

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).

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Interventional
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Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Open Label
Type 2 Diabetes
  • Drug: liraglutide
    1.8mg subcutaneous qd for 3 months
    Other Name: Vyctoza
  • Drug: insulin detemir
    5units subcutaneous bid titrated to fasting glucose of <130mg/dL for 3 months
    Other Name: Levemir
  • 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
  • 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.
    Intervention: Drug: liraglutide
  • 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.
    Intervention: Drug: insulin detemir
  • 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.
    Intervention: Drug: liraglutide plus insulin detemir
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
27
December 2015
December 2015   (final data collection date for primary outcome measure)

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).
Both
18 Years to 50 Years
No
United States
 
NCT01232946
1105005578
Yes
Indiana University
Indiana University
Novo Nordisk A/S
Principal Investigator: Kieren J Mather, MD Indiana University
Indiana University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP