At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 505 enrolled
Drug / intervention
Naltrexone SR 32 mg/bupropion SR 360 mg/ day +2 moredrug
Likely dose
Naltrexone SR 32 mg/bupropion SR 360 mg/ dayfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 3 clinical trial evaluating Naltrexone SR 32 mg/bupropion SR 360 mg/ day, Placebo, and 1 other intervention for Obesity and 2 related conditions. Completed, enrolled 505 participants across 53 sites.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsObesity, Overweight, Diabetes Mellitus, Type 2
CountriesUnited States
Collaborators--
Timeline
Phase 3CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartMay 2007
First PostedMay 2007
Primary CompletionJun 2009
TodayJul 2026
First PostedMay 17, 2007
Enrollment StartMay 1, 2007
Primary CompletionJun 1, 2009
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 19.1 years ago
Interventions
Naltrexone SR 32 mg/bupropion SR 360 mg/ daydrug
Placebodrug
Ancillary therapybehavioral
Ancillary therapy consisting of diet instruction, advice on behavior modification, and exercise counseling