A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes

What Was Tested

This registered phase 2 trial tested Liraglutide.

It had five arms (groups): one (experimental), one (experimental), one (experimental), Placebo + Metformin (placebo comparator) and Liraglutide + Metformin (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 834 actual participants took part.

It was open to people of any sex aged from 18 years up to 130 years.

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

Examples of who could join: Provision of informed consent. Male and female subjects aged ≥ 18 years at screening. Body mass index ≥ 25 kg/m2 at screening.

The full record lists 6 inclusion and 11 exclusion criteria; among the exclusions: severe allergy/hypersensitivity to any of the proposed study treatments or excipients; severely uncontrolled hypertension; unstable angina pectoris, myocardial infarction (mi), transient ischaemic attack (tia), or stroke within 3 months prior to screening.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Liraglutide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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, care provider and investigator.

It started in 2017-08-02 with completion listed for 2018-05-03.

It ran at 119 sites in United States (22), Germany (19), Slovakia (17), Russia (16), Canada (15) and Bulgaria (13).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in HbA1c (time frame: From baseline to 14 weeks). Percent Change in Body Weight (time frame: From baseline to 14 weeks).

It also tracked 11 secondary outcomes, for example Change in HbA1c, Percent Change in Body Weight, Absolute Change in Body Weight, Percent Change in Body Weight Versus Active Comparator, Absolute Change in Body Weight Versus Active Comparator and Percentage of Participants Rescued or Discontinued for Lack of Glycaemic Control.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Liraglutide in 834 people.

With 834 participants it is a large trial for this field.

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.