MEDI0382 in patients with T2DM and Renal Impairment
Research type
Research Study
Full title
A Phase 2a, Randomised, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of MEDI0382 in Subjects with Type 2 Diabetes Mellitus and Renal Impairment
IRAS ID
242873
Contact name
Rory McCrimmon
Contact email
Sponsor organisation
MedImmune Limited, a wholly owned subsidiary of AstraZeneca
Eudract number
2018-000019-26
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 7 months, 2 days
Research summary
MEDI0382 is an experimental medication being developed as a potential treatment for type 2 diabetes mellitus (T2DM). In many cases of T2DM, significant weight loss can promote improvements in blood sugar control, risk of heart disease, and death, and may even slow or reverse disease progression. Many existing therapies for T2DM focus on lowering blood sugar levels; however, there is a major unmet need for treatments that both improve blood sugar control and achieve disease-modifying weight loss. Impaired kidney function attributed to prolonged chronic high blood sugar and high blood pressure is common in patients with longstanding T2DM, and is often exacerbated by obesity. Patients with significant kidney problems and T2DM therefore stand to benefit from medications that can deliver both improvements in blood sugar control and weight loss
The purpose of this research study is to find out if MEDI0382 is effective and safe in treating adult subjects with T2DM and kidney problems and to learn more about how the study drug is processed by the body.
40 subjects will be randomly allocated to receive either MEDI0382 or placebo. Participation in the study will last about 3 months and involve 14 visits to clinic. Subjects will undergo blood and urine tests, 24-hour blood pressure and heart rate monitoring, ECGs, physical examinations, and wear a continuous glucose monitor to measure tissue glucose levels for the duration of the study.
The study will be carried out in approximately 9 research sites in Europe.
REC name
West of Scotland REC 1
REC reference
18/WS/0062
Date of REC Opinion
24 Apr 2018
REC opinion
Further Information Favourable Opinion