Effects of Single Doses of Liraglutide and Dapagliflozin on Ketogenesis in Type 1 Diabetes

What Was Tested

The trial (not phased) is built around Liraglutide.

To compare plasma levels of free fatty acid, glucagon, hs-CRP, Ll-6 and IL-1 before and after administration of liraglutide/placebo.

It had three arms (groups): one (active comparator), Placebo (placebo comparator) and Dapagliflozin (active comparator).

The registry classes the interventions as drug.

More on the Plan

Diabetic ketoacidosis is an important cause of mortality and morbidity in type 1 patients.

In patients with type 1 diabetes, the suppressive effect of hyperglycemia and the paracrine inhibitory effect of insulin and GABA from the β cell on α cell are absent.

Thus, both fatty acid oxidation and ketogenesis are enhanced.

It is essential to investigate this area further as there are no prior studies that have investigated the acute effects of liraglutide on FFAs or ketogenesis.

Who Took Part

43 actual participants took part.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Type 1 Diabetes on continuous subcutaneous insulin infusion (CSII, also known as insulin pump). Undetectable c peptide (c-peptide \< 0.1 ng/ml). Age 18-75 inclusive.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: type 1 diabetes for less than 12 months; coronary event/ procedure (mi, unstable angina, cabg, pci) in the last four weeks; hepatic disease (transaminase \> 3 times normal) or cirrhosis.

How the Study Was Run

The set-up was randomized, parallel-group and single-blind.

The participants were allocated by chance, so the Liraglutide group and the comparison group should start out alike.

The Liraglutide group and the comparison group ran side by side rather than switching.

In this single-blind Liraglutide study one party knew the assignments and the other did not.

Those kept unaware of assignments: participant.

It started in 2016-03-01 with completion listed for 2016-12-01.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

It also tracked 3 secondary outcomes, for example Change in Glucagon Levels, Change in Free Fatty Acid (FFA) Concentrations and Change in Ghrelin Concentrations.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Liraglutide in 43 people.

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

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