The Effect of Liraglutide on the Treatment of Coronary Artery Disease and Type 2 Diabetes

What Was Tested

The trial (phase 4) is built around Liraglutide.

The purpose of this study is to investigate the effect of combined glucagon-like-peptide-1 (GLP-1) analogue and metformin therapy on glucose metabolic and cardiovascular endpoints compared to metformin monotherapy in patients with coronary artery disease (CAD) and newly diagnosed type 2 diabetes (T2D).

The present study on CAD patients with newly diagnosed T2D will address these selected endpoints during an investigator initiated, randomized, double blind, crossover, placebo-controlled 12 + 12 weeks intervention study with a 2 week wash-out period.

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

The registry classes the interventions as drug.

More on the Plan

The total study period for each patient will be 26 weeks (12 plus 12 weeks of intervention with a 2 week wash-out period).

The endpoints will be evaluated at baseline (week 0), at week 12, at week 14 (following 2 weeks of wash-out) and finally at week 26.

Who Took Part

Enrollment: 41 actual participants took part.

It was open to people of any sex aged from 18 years up to 85 years.

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

Examples of who could join: Stable CAD documented by one of the following:. Previous MI (a minimum of 6 weeks after an acute MI). Previous coronary revascularization. Body mass index (BMI) \>/= 25,0 kg/m2. Age \>/= 18 years and \</= 85 years.

The full record lists 10 inclusion and 25 exclusion criteria; among the exclusions: type 1 diabetes mellitus defined as c-peptide \< 450 pm; previously diagnosed diabetes mellitus for more than 24 months prior to the screening procedure for this trial, except from gestational diabetes; uncontrolled arterial hypertension (\> 180/100 mmhg) at the time of screening.

How the Study Was Run

It was run as a randomized, crossover and quadruple-blind study.

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

Each person switched between Liraglutide and the comparison at some point, usually with a gap in between.

As a double-blind Liraglutide study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2012-05 with completion listed for 2014-10.

It ran at 1 site in Denmark.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Beta-cell function (time frame: after 12 weeks of intervention). LVEF (time frame: after 12 weeks of intervention).

It also tracked 10 secondary outcomes, for example Glucagon, incretin, glucose, NEFA, insulin and C-peptide response during meal test, CRP, TNF-alfa and IL-6 in plasma and gene expression of IL6 and TNF-alfa in subcutaneous fat, Non esterified fatty acids (NEFA), Heart rate variability (HRV), Maximal velocity of the myocardium in systole (s´) and in diastole (e´) and ST-depression and ectopic activity.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Liraglutide in 41 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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