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Trial · Interventional

CompletedNot applicableResults postedRegistry data

Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake

NCTNCT01232946 (opens ClinicalTrials.gov in a new tab)Other id1105005578
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Not applicable
Enrollment
30 participants (actual)
Sponsor
Indiana University · Other
Design
Randomized · Open label (no masking)
Countries
1 country

United States

Start
Jan 2012
Primary completion
8 Sept 2017
Completion
8 Sept 2017
First posted
2 Nov 2010 (estimated)
Last update posted
7 Aug 2019
Conditions
Type 2 Diabetes

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015201620172018
  1. N/A

    Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake

    NCT01232946

    Jan 2012 to 8 Sept 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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).

Interventions

  • liraglutideDrug
  • insulin detemirDrug
  • liraglutide plus insulin detemirDrug

Arms3

  • Experimental

    Iiraglutide

    Type 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.

  • Experimental

    insulin detemir

    Type 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.

  • Experimental

    Liraglutide plus insulin detemir

    Type 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.

Primary outcomes3

Outcomes the sponsor listed as primary.

  1. Myocardial Glucose Uptake

    Time frame · 3 months

    Registry description

    PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir

  2. Myocardial Fatty Acid Oxidation Rate

    Time frame · 3 months

    Registry description

    PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir

  3. Myocardial Fatty Acid Esterification Rate

    Time frame · 3 months

    Registry description

    PET measurements of myocardial glucose uptake will be done after 3 months of exposure to liraglutide, insulin detemir, or liraglutide plus insulin detemir

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· 3 months

Myocardial Glucose Uptake

GroupValue (umol/g/min)
Iiraglutide0.055
Insulin Detemir0.0399
Liraglutide Plus Insulin Detemir0.0373
Primary outcomeMedian· 3 months

Myocardial Fatty Acid Oxidation Rate

GroupValue (umol/g/min)
Iiraglutide0.1019
Insulin Detemir0.1234
Liraglutide Plus Insulin Detemir0.0992
Primary outcomeMedian· 3 months

Myocardial Fatty Acid Esterification Rate

GroupValue (umol/g/min)
Iiraglutide0.00274
Insulin Detemir0.00358
Liraglutide Plus Insulin Detemir0.00146

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
IiraglutideType 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. liraglutide: 1.8mg subcutaneous qd for 3 months0 / 90 / 90 / 9
Insulin DetemirType 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. insulin detemir: 5units subcutaneous bid titrated to fasting glucose of \<130mg/dL for 3 months1 / 100 / 100 / 10
Liraglutide Plus Insulin DetemirType 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. liraglutide plus insulin detemir: liraglutide 1.8mg subq qd plus insulin detemir 5units bid titrated to fasting blood glucose \<130mg/dL for 3 months.0 / 110 / 112 / 11

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Randomized controlled trial · 2018

4 results

Combination GLP-1 and Insulin Treatment Fails to Alter Myocardial Fuel Selection vs. Insulin Alone in Type 2 Diabetes.

Mather et al. 2018The Journal of clinical endocrinology and metabolismcited by 5

PMID 30020461PMC6126889DOI 10.1210/jc.2018-00712PUB-30020461

Rights unknown4 results
Source linkSee results (4)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 50 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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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