Type 2 Diabetes Mellitus Clinical Trial
Official 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
A Phase 2 study Comparing the effects on glucose control of MEDI0382 in combination with Dapagliflozin and Metformin compared to placebo in combination with Dapagliflozin and Metformin in overweight/obese participants with Type 2 Diabetes Mellitus (T2DM).
This is an exploratory randomized, double-blind, placebo-controlled study to evaluate the
efficacy and safety of MEDI0382 versus placebo in overweight/obese participants with T2DM
treated with metformin and dapagliflozin dual therapy. The study will enroll participants
with T2DM treated either with metformin monotherapy or with metformin and dapagliflozin dual
therapy. After the screening period, participants treated with metformin monotherapy only
will enter a 4-week run-in period where participants will be administered oral dapagliflozin
10 mg a day, which will be provided by the sponsor. Enrolled participants that are already
treated with metformin and dapagliflozin dual therapy will continue this dual therapy
throughout the study and can be randomized after the screening period without entering the
run-in period. All participants (ie, on monotherapy and dual therapy) entering the
double-blind treatment period will receive dapagliflozin 10 mg a day, which will be provided
by the sponsor.
Participants in this study will participate for up to 20 weeks including a screening period
of up to 60 days, a 4-week run-in period (for participants on metformin monotherapy only), a
4-week treatment period, and a 4-week follow-up post-treatment period.
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