Cooperation of Insulin and GLP-1 on Myocardial Glucose Uptake

What Was Tested

The trial (not phased) is built around Insulin Detemir and Liraglutide.

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).

It had three arms (groups): Iiraglutide (experimental), insulin detemir (experimental) and Liraglutide plus insulin detemir (experimental).

The registry classes the interventions as drug.

More on the Plan

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).

Who Took Part

Enrollment: 30 actual participants took part.

It was open to people of any sex aged from 18 years up to 50 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Type 2 diabetic. BMI \> 25kg/m2. Treated with up to 2 oral agents.

The full record lists 5 inclusion and 10 exclusion criteria; among the exclusions: 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.

How the Study Was Run

The set-up was randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin Detemir and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Everyone knew when Insulin Detemir was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

It started in 2012-01 with completion listed for 2017-09-08.

It ran at 1 site in United States.

Its stated primary purpose is other.

What Was Measured

Researchers chose this as the main measure: Myocardial Glucose Uptake (time frame: 3 months). Myocardial Fatty Acid Oxidation Rate (time frame: 3 months). Myocardial Fatty Acid Esterification Rate (time frame: 3 months).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin Detemir and Liraglutide in 30 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin Detemir compound page and the Liraglutide compound page, all human trials.