MEDI0382 in Type 2 Diabetes
Research type
Research Study
Full title
An Exploratory Phase 2a, Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect of MEDI0382 on Energy Balance in Overweight and Obese Subjects with Type 2 Diabetes Mellitus
IRAS ID
246695
Contact name
Mark Evans
Contact email
Sponsor organisation
MedImmune Limited, a wholly owned subsidiary of AstraZeneca
Eudract number
2018-001220-19
Duration of Study in the UK
0 years, 8 months, 0 days
Research summary
The purpose of the study is to evaluate the effect of MEDI0382 on energy balance and weight loss in subjects who are overweight and obese with T2DM.
About 24 people will participate in the study. Eligible patients will be randomised to receive a placebo for 16 days, and then either study drug or placebo for 42 days. Patients will be in the study for up to 114 days, including a screening period of up to 28 days, a 16 day placebo single-blind treatment period, a 42 day double-blind treatment period, and a 28 day safety follow-up period.
A number of assessments and procedures will be performed during the study, including physical examinations, quality of life questionnaires, blood and urine sample assessments, muscle biopsies, 12-lead ECGs (electrocardiograms), whole room calorimetry and DXA (dual energy X-ray absorptiometry) scans to measure change in total body fat mass. These assessments are performed as part of the evaluation to determine if the study drug is safe and effective.
REC name
East of England - Essex Research Ethics Committee
REC reference
18/EE/0204
Date of REC Opinion
25 Jul 2018
REC opinion
Further Information Favourable Opinion