A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.

What Was Tested

The trial (phase 2) is built around Liraglutide.

A phase 2 study in two parts (A \& B) designed to evaluate the effect of MEDI0382 on Hepatic Glycogen Metabolism in subjects with Type 2 Diabetes Mellitus (T2DM).

Approximately 20 subjects will be enrolled in Part A and approximately 30 subjects in Part B.

It had five arms (groups): MEDI0382 (Part A) (experimental), Placebo (Part A) (placebo comparator), Liraglutide (Part B) (active comparator), MEDI0382 (Part B) (experimental) and Placebo (Part B) (placebo comparator).

MEDI0382 administered subcutaneously (Part A).

Placebo comparator administered subcutaneously (Part A).

Active comparator administered subcutaneously (Part B).

The registry classes the interventions as drug.

More on the Plan

This is a 2-part exploratory Phase 2 study.

Part A is a randomised, double-blind, placebo-controlled study to evaluate the effect of MEDI0382 (also known as Cotadutide) administered once daily subcutaneously (SC) for 28 days on hepatic glycogen metabolism in overweight and obese subjects with T2DM.

Part A is planned to randomise up to 20 subjects.

Subjects from Part A will not be re-enrolled in Part B.

Who Took Part

Enrollment: 51 actual participants took part.

It was open to people of any sex aged from 18 years up to 99 years.

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

Examples of who could join: Body mass index (BMI) ≥ 27 and ≤ 40 kg/m2 (inclusive) at screening.

The full record lists 3 inclusion and 25 exclusion criteria; among the exclusions: any subject who has received any of the following medications prior to the start of the study:; herbal preparations or drugs licensed for control of body weight or appetite (eg, orlistat, bupropion naltrexone, phentermine-topiramate, phentermine, lorcaserin); opiates, domperidone, metoclopramide or other drugs known to alter gastric emptying.

How the Study Was Run

It was run as a randomized, parallel-group and double-blind study.

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

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

Blinding on both sides kept the participants and researchers unaware of who received Liraglutide.

Those kept unaware of assignments: participant and investigator.

It started in 2018-05-31 with completion listed for 2021-04-14.

It ran at 3 sites in Netherlands (1), Sweden (1) and United Kingdom (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Change in Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 4 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 28 Days of Treatment (Part A Only) (time frame: Day -1 to Day 28). Percentage Change in Fasting Hepatic Glycogen Concentration Adjusted for Liver Volume as Measured by MRS at T = 24 Hours Post Standardised Morning Meal From Baseline (Day -1) to the End of 35 Days of Treatment (Day 36) (Part B) (time frame: Day -1 to Day 36).

It also tracked 8 secondary outcomes, for example Development of ADA.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 51 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.