CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 49 enrolled
Drug / intervention
MEDI0382 +3 moredrug
Likely dose
MEDI0382 100 μgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03444584
NCT03444584Phase 2Completed

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

MedImmune LLC·interventional·Posted Feb 23, 2018·Updated Jan 13, 2020

In Brief

A Phase 2 clinical trial evaluating MEDI0382, Placebo, and 2 other interventions for Type 2 Diabetes Mellitus. Completed, enrolled 49 participants across 8 sites in 3 countries.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesGermany, Hungary, United Kingdom
Collaborators--

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedFeb 23, 2018
Enrollment StartMay 8, 2018
Primary CompletionDec 6, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 8.4 years ago

Interventions

MEDI0382drug

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).

Placebodrug

Subcutaneous dose of placebo matched to MEDI0382.

Dapaglifozindrug

Oral dose of dapaglifozin 10 mg tablet.

Metformindrug

Oral dose of metformin tablet (maximum tolerated dose \[MTD\] \> 1 g).