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

Summary

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 20 subjects will be enrolled in Part A and approximately 30 subjects in Part B.

Timeline

Start

2018-05-31

Primary completion

2021-04-14

Completion

2021-04-14

Outcome

Met primary endpoint

paper The trial met its primary endpoint. PMID 38066113 ↗

registry analysis (superiority test); Placebo (Part A) vs MEDI0382 (Part A); p = 0.023; Least square mean difference -105.7 (90% CI -178.8 to -32.6); ANCOVA NCT03555994 ↗

registry analysis (superiority test); MEDI0382 (Part B) vs Placebo (Part B); p = 0.008; Least square mean difference -25.87 (90% CI -40.88 to -10.86); ANCOVA NCT03555994 ↗

Publications

• Parker VER, Robertson D, Erazo-Tapia E, Havekes B, Phielix E, de Ligt M, Roumans KHM, Mevenkamp J, Sjoberg F, Schrauwen-Hinderling VB, Johansson E, Chang YT, Esterline R, Smith K, Wilkinson DJ, Hansen L, Johansson L, Ambery P, Jermutus L, Schrauwen P. Cotadutide promotes glycogenolysis in people with overweight or obesity diagnosed with type 2 diabetes. Nat Metab. 2023 Dec;5(12):2086-2093. doi: 10.1038/s42255-023-00938-0. Epub 2023 Dec 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cotadutide	Peptide	—	Subcutaneous
Comparator	Liraglutide	Peptide	—	Subcutaneous

Indications