A Safety and Efficacy Study Comparing Naltrexone SR/Bupropion SR and Placebo in Obese Subjects With Type 2 Diabetes

Phase 3 Completed 505 enrolled Orexigen Therapeutics, Inc

RandomizedParallel-groupTriple-blindTreatment

Summary

The purpose of this study is determine whether the combination of naltrexone SR and bupropion SR is safe and effective in treating obesity in subjects with type 2 diabetes.

Timeline

Start: 2007-05
Primary completion: 2009-06
Completion: 2009-06

Outcome

Met primary endpoint

registry analysis (superiority or other test); NB32 vs Placebo; p <0.001; Mean Difference (Net) -3.28 (95% CI -4.34 to -2.22); ANCOVA NCT00474630 ↗

registry analysis (superiority or other test); NB32 vs Placebo; p <0.001; Odds Ratio (OR) 3.44 (95% CI 2.15 to 5.50); Regression, Logistic NCT00474630 ↗

Publications

Results Hollander P, Gupta AK, Plodkowski R, Greenway F, Bays H, Burns C, Klassen P, Fujioka K; COR-Diabetes Study Group. Effects of naltrexone sustained-release/bupropion sustained-release combination therapy on body weight and glycemic parameters in overweight and obese patients with type 2 diabetes. Diabetes Care. 2013 Dec;36(12):4022-9. doi: 10.2337/dc13-0234. Epub 2013 Oct 21.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Bupropion	Small molecule	360 mg	—
Subject	Naltrexone	Small molecule	32 mg	—