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

Registration

Registration

NCT03444584

Study type

INTERVENTIONAL

Allocation

RANDOMIZED

Phase

PHASE2

Masking

QUADRUPLE

Status

COMPLETED

Enrollment

49

Start

2018-05-08

Primary completion

2018-12-06

Lead sponsor

MedImmune LLC

Conditions

Type 2 Diabetes Mellitus

Interventions

DRUG:MEDI0382; DRUG:Placebo; DRUG:Dapaglifozin; DRUG:Metformin

Results posted

TRUE

Individual participant data sharing

UNDECIDED

Secondary identifiers

EUDRACT_NUMBER:2017-002817-78; NIH:2017

Registered primary outcomes

• Change From Baseline to Day 28 in Plasma Glucose Area Under the Concentration Time-curve From Time 0 to 4 Hours (AUC0-4hrs) as Measured by Mixed-meal Tolerance Test (MMTT) [Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -1 (Baseline) and Day 28]
• Percent Change From Baseline to Day 28 in Plasma Glucose AUC0-4hrs as Measured by MMTT [Zero minutes before and 15, 30, 45, 60, 90, 120, 180, and 240 minutes after consumption of the standardised meal on Day -1 (Baseline) and Day 28]