Effect of Liraglutide on the Metabolic Profile in Patients With Type 2 Diabetes and Cardiovascular Disease

What Was Tested

The trial (phase 3) is built around Liraglutide.

It had two arms (groups): Liraglutide (active comparator) and Placebo (placebo comparator).

Matching Placebo once daily, subcutaneous injection via pre-filled pen.

The registry classes the interventions as drug.

Who Took Part

It was open to people of any sex aged from 18 years with no upper age limit.

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

Examples of who could join: Type 2 diabetes. Age ≥ 18 years. Patients with existing cardiovascular disease: coronary heart disease, cerebrovascular disease, peripheral vascular disease, chronic kidney disease of stage III or chronic heart failure of NYHA II or III). Written informed consent prior to study participation.

The full record lists 5 inclusion and 13 exclusion criteria; among the exclusions: type 1 diabetes; treatment with glp-1 receptor agonists or dpp-4 inhibitors within the last 4 weeks; patients with familiar or personal history of multiple endocrine neoplasia-type 2 or medullary c-cell cancer.

How the Study Was Run

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

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

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

Neither the participants nor the staff measuring them knew who was on Liraglutide, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2020-11 with completion listed for 2022-08.

It ran at 1 site in Germany.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Changes in the metabolomics profile (fold changes) between Liraglutide treatment group and placebo group after 1 and 3 months (time frame: 3 month).

It also tracked 15 secondary outcomes, for example change in left ventricular diastolic function, change in left ventricular diastolic function, change in left ventricular systolic function, Changes in systolic and diastolic blood pressure (mmHg), body weight and Changes in NT-proBNP serum levels (pg/ml).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Liraglutide in people.

It was withdrawn before enrolling anyone; no results are posted to the registry yet, so nothing here describes outcomes.

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