Last updated on June 2018

A Study to Investigate the Effect of MEDI0382 on Hepatic Glycogen Metabolism in Overweight and Obese Subjects With Type 2 Diabetes Mellitus.


Brief description of study

A phase 2 study in two parts (A & B) designed to evaluate the effect of MEDI0382 on Hepatic Glycogen Metabolism in subjects with Type 2 Diabetes Mellitus (T2DM). Approximately 16 subjects will be enrolled in Part A and approximately 24 subjects in Part B.

Detailed Study Description

This is a 2-part exploratory Phase 2 study.

Part A is a randomised, double-blind, placebo-controlled study to evaluate the effect of MEDI0382 administered once daily subcutaneously (SC) for 28 days on hepatic glycogen metabolism in overweight and obese subjects with T2DM. Part A is planned to randomise up to 16 subjects. Subjects will be consented, screened for suitability, and randomised within 60 days if eligible. Subjects from Part A will not be re-enrolled in Part B.

Part B is an exploratory Phase 2 randomised, double-blind, placebo-controlled and open-label active comparator study to evaluate the effect of MEDI0382 on hepatic glycogen metabolism in overweight and obese subjects with T2DM. Part B is planned to randomise approximately 24 subjects (not to exceed a maximum of 30 subjects); however, the exact sample size will be determined by the results obtained on hepatic glycogen concentrations in Part A. Subjects in Part B will be randomised to receive double-blind MEDI0382 or placebo, or open-label liraglutide once daily for 28 days. Both Part A and Part B will use the same schedule of study procedures.

Clinical Study Identifier: NCT03555994

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