NCT03235050|CompletedPhase 2ResultsFDA Drug

A Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes

A Phase IIb, Randomised, Parallel, Double-Blind Placebo-Controlled and Open-Label Active Comparator Study to Evaluate the Efficacy and Safety of MEDI0382 in the Treatment of Overweight and Obese Subjects With Type 2 Diabetes Mellitus

AstraZeneca ClinicalTrials.gov

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1 other identifier

D5670C00004

Study Type

interventional

Target

834

Locations

8 countries

Sites

119

Timeline

RegisteredAug 2017

StartedAug 2017

CompletionJun 2019

Brief Summary

This study is designed to evaluate the dose range for MEDI0382 with respect to blood glucose control and weight loss effects, as well as to further explore the safety profile of MEDI0382

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

834

participants targeted

Target at P75+ for phase_2 diabetes-mellitus-type-2

Timeline

Completed

Started Aug 2017

Typical duration for phase_2 diabetes-mellitus-type-2

Geographic Reach

8 countries

119 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

1.9 years study duration

First Submitted

Initial submission to the registry

July 21, 2017

Completed

11 days until next milestone

First Posted

Study publicly available on registry

August 1, 2017

Completed

1 day until next milestone

Study Start

First participant enrolled

August 2, 2017

Completed

9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 3, 2018

Completed

1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 14, 2019

Completed

1.1 years until next milestone

Results Posted

Study results publicly available

July 20, 2020

Completed

Last Updated

August 17, 2020

Status Verified

July 1, 2020

Enrollment Period

9 months

First QC Date

July 21, 2017

Results QC Date

June 3, 2020

Last Update Submit

July 31, 2020

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (2)

Change in HbA1c
To assess the effect of 100, 200, 300 μg of cotadutide on HbA1c versus placebo
From baseline to 14 weeks
Percent Change in Body Weight
To assess the effect of 100, 200, 300 μg of cotadutide on body weight versus placebo
From baseline to 14 weeks

Secondary Outcomes (11)

Change in HbA1c
from baseline to 26 weeks and 54 weeks
Percentage of Participants Achieving an HbA1c Target < 7.0%
after 14, 26, and 54 weeks
Percent Change in Body Weight
from baseline to 26 weeks and 54 weeks
Absolute Change in Body Weight
from baseline to 14 weeks, 26 weeks and 54 weeks
Percent Change in Body Weight Versus Active Comparator
from baseline to 14 weeks, 26 weeks and 54 weeks
+6 more secondary outcomes

Study Arms (5)

MEDI0382 low dose + Metformin

EXPERIMENTAL

Drug: MEDI0382 low dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Drug: MEDI0382 low dose

MEDI0382 mid dose + Metformin

EXPERIMENTAL

Drug: MEDI0382 mid dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Drug: MEDI0382 mid dose

MEDI0382 high dose + Metformin

EXPERIMENTAL

Drug: MEDI0382 high dose Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Drug: MEDI0382 high dose

Placebo + Metformin

PLACEBO COMPARATOR

Drug: Placebo Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Drug: Placebo

Liraglutide + Metformin

ACTIVE COMPARATOR

Drug: Liraglutide Drug: Metformin tablets, total daily dose of ≥1500 mg (unless only tolerated at a lower dose)

Drug: Liraglutide