MEDI0382, a GLP-1 and glucagon receptor dual agonist, in obese or overweight patients with type 2 diabetes: a randomised, controlled, double-blind, ascending dose and phase 2a study

What Was Tested

Researchers studied Cotadutide in this randomized controlled trial publication.

Weight loss is often key in the management of obese or overweight patients with type 2 diabetes, yet few treatments for diabetes achieve clinically meaningful weight loss.

Who Took Part

By PubMed's age tags, the people studied were adults, middle-aged adults and older adults, both men and women.

An interactive web-response system was used to randomly assign patients to receive MEDI0382 or placebo.

Patients were randomly assigned 2:1 in cohorts A-C and 3:1 in cohorts D and E in the MAD portion of the study, and 1:1 in the phase 2a portion.

How the Study Was Run

The design is described as randomized, double-blind and placebo-controlled.

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

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

The comparison arm used a placebo, so changes seen with Cotadutide could be set against what happens without it.

Randomisation was done by a contracted third-party operator who was not involved in the clinical operations of the study.

Safety analyses were done in all participants who received any study drug analysed according to the treatment they received.

This study is registered with ClinicalTrials.gov, number NCT02548585.

What Was Measured

Topics PubMed links to this paper include Blood Glucose, Body Mass Index, Diabetes Mellitus, Type 2, Glucagon-Like Peptide 1, Glycated Hemoglobin, Hypoglycemic Agents and Obesity.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Cotadutide.

Results are reported in around 7 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2018 (Lancet (London, England)), a journal based in England.

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