NCT00474630

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

A Multicenter, Randomized, Double Blind, Placebo Controlled Study Comparing the Safety and Efficacy of Naltrexone 32 mg Sustained Release (SR)/Bupropion 360 mg Sustained Release (SR) and Placebo in Obese Subjects With Type 2 Diabetes Mellitus

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 505 (actual)
• Sponsor: Orexigen Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Optimal care of patients with diabetes mellitus includes vigorous and persistent efforts to achieve physiologic control of blood glucose as well as other often associated conditions including hypertension, dyslipidemia and excess weight. Pharmacologic interventions for the treatment of obesity in type 2 diabetes have shown significant reductions in HbA1c. Two Phase II clinical trials demonstrated that a combination of bupropion SR and naltrexone is associated with greater weight loss than bupropion SR alone, naltrexone alone, or placebo in subjects with uncomplicated obesity. The current study investigated the safety and efficacy of the combination of naltrexone SR and bupropion SR compared to placebo in obese subjects with type 2 diabetes mellitus.

Conditions

• Obesity
• Overweight
• Diabetes Mellitus, Type 2

Interventions

Type	Name	Description
DRUG	Naltrexone SR 32 mg/bupropion SR 360 mg/ day
DRUG	Placebo
BEHAVIORAL	Ancillary therapy	Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling

Timeline

• Start date: 2007-05-01
• Primary completion: 2009-06-01
• Completion: 2009-06-01
• First posted: 2007-05-17
• Last updated: 2014-11-21
• Results posted: 2014-11-21

Locations

53 sites across 1 country: United States