Study identifier:D5670C00007
ClinicalTrials.gov identifier:NCT03444584
EudraCT identifier:2017-002817-78
CTIS identifier:N/A
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
Type 2 Diabetes Mellitus
Phase 2
No
MEDI0382, Placebo, Dapaglifozin, Metformin
All
49
Interventional
18 Years - 115 Years
Allocation: Randomized
Endpoint Classification: -
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Verified 01 Jan 2020 by MedImmune, LLC
MedImmune, LLC
-
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.
Location
Location
Balatonfüred, Hungary, 8230
Location
Szeged, Hungary, 6720
Location
Miskolc, Hungary, 3529
Location
Mannheim, Germany, 68167
Location
München, Germany, 81241
Location
Magdeburg, Germany, 39120
Location
Rotherham, United Kingdom, S65 1DA
Location
Manchester, United Kingdom, M13 9NQ
Arms | Assigned Interventions |
---|---|
Experimental: MEDI0382 Participants will receive subcutaneous dose of MEDI0382 daily (titrated up from 100 μg for 7 days to 200 μg for 7 days and to 300 μg for 14 days) for 28 days. Participants were on metformin and dapagliflozin background dual therapy during the treatment period. | 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: Dapaglifozin Oral dose of dapaglifozin 10 mg tablet. Drug: Metformin Oral dose of metformin tablet (maximum tolerated dose [MTD] > 1 g). |
Placebo Comparator: Placebo Participants will receive subcutaneous dose of placebo matched to MEDI0382 daily for 28 days. Participants were on metformin and dapagliflozin background dual therapy during the treatment period | 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). |
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