Efficacy and Mechanism of Exenatide on Improving Heart Function in Type 2 Diabetes With Heart Failure Patients

What Was Tested

The trial (not phased) is built around Exenatide.

It had two arms (groups): Exenatide (experimental) and control group (no intervention).

Control group do not receive exenatide.

The registry classes the interventions as drug.

More on the Plan

The study enrolls 234 patients with type 2 diabetes and heart failure.

The patients have an New York Heart Association (NYHA) functional class of II to IV, are randomly assigned to 2 groups.

One group use exenatide , the other group is control group and each group has 117 patients.

At the baseline, the 3rd day, the 28th day patients are required to complete the heart failure examination: plasma N-terminal pro-B-type natriuretic peptide(NT-proBNP), 6-min walking distance, echocardiographic measures, patient quality of life(MLHFQ).

Who Took Part

234 planned participants were the target.

It was open to people of any sex aged from 18 years up to 65 years.

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

Examples of who could join: Diagnosed Type 2 diabetes mellitus. Age 18-65 years. NT-proBNP level≥ 450 pg/ml.

The full record lists 5 inclusion and 21 exclusion criteria; among the exclusions: uncorrected primary vascular disease; congenital heart disease; left ventricular outflow obstruction.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

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

It started in 2015-01 with completion listed for 2016-12.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The change in plasma NT-proBNP level after using exenatide for 4 weeks (time frame: 4 weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Exenatide in 234 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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