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

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

Timeline

Start

2017-08-02

Primary completion

2018-05-03

Completion

2019-06-14

Outcome

Met primary endpoint

paper Cotadutide significantly decreased HbA1c and body weight at weeks 14 and 54 versus placebo (all P < 0.001). PMID 34016612 ↗

registry analysis (superiority test); Placebo vs MEDI0382 100 mcg; p <0.001; LS Mean Difference -0.83 (95% CI -1.06 to -0.59); ANCOVA NCT03235050 ↗

registry analysis (superiority test); Placebo vs MEDI0382 100 mcg; p <0.001; LS Mean Difference -2.00 (95% CI -3.08 to -0.91); ANCOVA NCT03235050 ↗

Publications

• Nahra R, Wang T, Gadde KM, Oscarsson J, Stumvoll M, Jermutus L, Hirshberg B, Ambery P. Effects of Cotadutide on Metabolic and Hepatic Parameters in Adults With Overweight or Obesity and Type 2 Diabetes: A 54-Week Randomized Phase 2b Study. Diabetes Care. 2021 Jun;44(6):1433-1442. doi: 10.2337/dc20-2151. Epub 2021 May 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cotadutide	Peptide	100 ug	Subcutaneous
Subject	Cotadutide	Peptide	200 ug	Subcutaneous
Subject	Cotadutide	Peptide	300 ug	Subcutaneous
Comparator	Liraglutide	Peptide	1.8 mg	Subcutaneous

Indications