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Clinical Trial Details

Trial ID: L6925
Source ID: NCT04307797
Associated Drug: 0.9% Sodium-Chloride
Title: Effect of Glucagon and Glucagon-like Peptide-1 Co-agonism on Cardiac Function and Metabolism in Overweight Participants with Type 2 Diabetes
Acronym: COCONUT
Status: COMPLETED
Study Results: NO
Results:
Conditions: Type 2 Diabetes|Obesity
Interventions: DRUG: 0.9% Sodium-chloride|DRUG: Exenatide (50ng/min for 30 minutes loading followed by 25ng/min maintenance) and glucagon 12.5ng/kg/min|DRUG: Glucagon 12.5ng/kg/min and 0.9% saline|DRUG: 0.9% Sodium-chloride|DRUG: Exenatide (50ng/min for 30 minutes loading followed by 25ng/min maintenance) and glucagon 12.5ng/kg/min|DRUG: Glucagon 12.5ng/kg/min
Outcome Measures: Primary: Part A - Myocardial glucose uptake, Difference in myocardial glucose uptake between 0.9% saline, glucagon:exenatide and glucagon scan as measured by 18F-FDG, Comparison between scans over a maximum period of 16 weeks|Part A - Global longitudinal strain / global circumferential strain / global radial strain, Difference in global longitudinal strain / global circumferential strain / global radial strain between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR, Comparison between scans over a maximum period of 16 weeks|Part A - Ejection fraction, Difference in ejection fraction between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR, Comparison between scans over a maximum period of 16 weeks|Part A - Stroke volume, Difference in stroke volume between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR, Comparison between scans over a maximum period of 16 weeks|Part A - Cardiac output, Difference in cardiac output between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR, Comparison between scans over a maximum period of 16 weeks|Part B - Changes in phosphocreatine/adenosine (PCr/ATP) radio, Changes in PCr/ATP radio between 0.9% saline, glucagon:exenatide and glucagon (optional) in the mid-interventricular septum as a measure of cardiac energy status as measured by 7T phosphorus (P) 31 magnetic resonance spectroscopy (MRS), Comparison between scans over a maximum period of 16 weeks|Part B - Changes in absolute concentrations of PCr and ATP defined by AHA 17- segment territory as a measure of cardiac energy status (determined by 31P-MRS), Changes in absolute concentrations of PCr and ATP between 0.9% saline, glucagon:exenatide and glucagon (optional) as defined by AHA 17-segment territory as a measure of cardiac energy status (determined by 7T 31P-MRS), Comparison between scans over a maximum period of 16 weeks | Secondary: Part A - End systolic/diastolic ventricular/atrial volumes, Difference in end systolic/diastolic ventricular/atrial volumes between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR, Comparison between scans over a maximum period of 16 weeks|Part A - Radial strain, Difference in radial strain between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR, Comparison between scans over a maximum period of 16 weeks|Part A - Global systolic/diastolic longitudinal/circumferential/radial strain rate, Difference in global systolic/diastolic longitudinal/circumferential/radial strain rate between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR, Comparison between scans over a maximum period of 16 weeks|Part A - Relationship between early and late filling (from mitral flow), Difference in early and late filling (from mitral flow) between 0.9% saline, glucagon:exenatide and glucagon scan as measured by CMR, Comparison between scans over a maximum period of 16 weeks|Part A/B - Heart rate, Difference in heart rate between 0.9% saline, glucagon:exenatide and glucagon, Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks|Part A/B - Blood pressure, Difference in blood pressure between 0.9% saline, glucagon:exenatide and glucagon, Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks|Part A/B - Glucose, Difference in glucose between 0.9% saline, glucagon:exenatide and glucagon, Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks|Part A/B - Glucagon, Difference in glucagon between 0.9% saline, glucagon:exenatide and glucagon, Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks|Part A/B - Insulin, Difference in insulin between 0.9% saline, glucagon:exenatide and glucagon, Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks|Part A/B - C-peptide, Difference in C-peptide between 0.9% saline, glucagon:exenatide and glucagon, Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks|Part A/B - fatty acids, Difference in fatty acids between 0.9% saline, glucagon:exenatide and glucagon, Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks|Part A/B - exenatide, Difference in exenatide between 0.9% saline, glucagon:exenatide and glucagon, Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks|Part A/B - Total GLP-1 and total active GLP-1, Difference in GLP-1 between 0.9% saline, glucagon:exenatide and glucagon, Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks|Part A/B - gastric inhibitory polypeptide, Difference in gastric inhibitory polypeptide between 0.9% saline, glucagon:exenatide and glucagon, Comparison between infusions (placebo vs drug) over a maximum period of 16 weeks
Sponsor/Collaborators: Sponsor: Cambridge University Hospitals NHS Foundation Trust | Collaborators: Antaros Medical
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE4
Enrollment: 10
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: SINGLE (PARTICIPANT)|Primary Purpose: BASIC_SCIENCE
Start Date: 2022-01-18
Completion Date: 2022-10-07
Results First Posted:
Last Update Posted: 2024-09-19
Locations: Cambridge University Hospitals NHS Foundation Trust and The University of Cambridge, Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
URL: https://clinicaltrials.gov/show/NCT04307797