Conditions: Obesity Overweight Diabetes Mellitus, Type 2
Keywords: Obesity Overweight Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 505
Healthy volunteers: no

Brief 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.

Arms:
arm 1: Naltrexone SR 32 mg/bupropion SR 360 mg/ day with ancillary therapy arm 2: Placebo with ancillary therapy

Interventions: intervention 1: Naltrexone SR 32 mg/bupropion SR 360 mg/ day intervention 2: Placebo intervention 3: Ancillary therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling

Protocol document: