NCT03444584

Study of MEDI0382 in Combination With Dapagliflozin and Metformin in Overweight/Obese Participants With Type 2 Diabetes

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 49 (actual)
• Sponsor: MedImmune LLC · Industry
• Sex: All
• Age: 18 Years – 115 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	MEDI0382	Subcutaneous dose of MEDI0382 (titrated up from 100 μg for 7 days to 200 μg for 7 days and to 300 μg for 14 days).
DRUG	Placebo	Subcutaneous dose of placebo matched to MEDI0382.
DRUG	Dapaglifozin	Oral dose of dapaglifozin 10 mg tablet.
DRUG	Metformin	Oral dose of metformin tablet (maximum tolerated dose \[MTD\] \> 1 g).

Timeline

• Start date: 2018-05-08
• Primary completion: 2018-12-06
• Completion: 2018-12-06
• First posted: 2018-02-23
• Last updated: 2020-01-13
• Results posted: 2020-01-13

Locations

8 sites across 3 countries: Germany, Hungary, United Kingdom