Evaluating MEDI0382 vs Placebo in Patients with Type 2 Diabetes
Research type
Research Study
Full title
An Exploratory Phase 2a Randomized, Placebo-controlled, Double-blind Study to Evaluate the Efficacy and Safety of MEDI0382 versus Placebo in Overweight/Obese Subjects with Type 2 Diabetes Mellitus Treated with Dapagliflozin and Metformin
IRAS ID
235553
Contact name
Stephen Bain
Contact email
Sponsor organisation
MedImmune Limited, a wholly owned subsidiary of AstraZeneca
Eudract number
2017-002817-78
Duration of Study in the UK
0 years, 6 months, 8 days
Research summary
This study is designed to see if the new investigational medication called ‘MEDI0382’ is effective and safe in treating overweight and obese patients with Type 2 Diabetes Mellitus (T2DM) who are treated with metformin and dapagliflozin. To do this, MEDI0382 will be compared with placebo. Participants will have an equal chance of receiving MEDI0382 or placebo.
MEDI0382 is a chemically created protein being developed to achieve both better blood glucose control and possible weight reduction. Dapagliflozin is an approved oral medication to treat T2DM. Dapagliflozin works in the kidneys, where it allows the body to excrete excess sugar from the blood into the urine.
Participation in this study could last 4 to 6 months, including a screening period of up to 60 days, a 4-week run-in period (for patients receiving metformin only, during which they start treatment with dapagliflozin), a 4-week treatment period, and a 4-week post-treatment follow-up period.
The study medication will be administered via subcutaneous (beneath the skin) injection once daily in the lower abdomen.
Participants will need to attend regular study visits (including 2 inpatient stays) where tests will be performed to see if the patient is able to continue in the study and to check the patient’s health and the effects of the study medication.
46 people will take part in this study at 8 sites in the UK and Hungary.
MedImmune Limited is funding the research.
REC name
London - Riverside Research Ethics Committee
REC reference
17/LO/1879
Date of REC Opinion
16 Nov 2017
REC opinion
Unfavourable Opinion