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| Sponsored by: |
Orexigen Therapeutics, Inc |
| Information provided by: | Orexigen Therapeutics, Inc |
| ClinicalTrials.gov Identifier: | NCT00474630 |
Purpose
The purpose of this study is determine whether a combination of 2 drugs is safe and effective in treating obesity in type 2 diabetics.
| Condition | Intervention | Phase |
|
Obesity Diabetes Mellitus, Type 2 |
Drug: Naltrexone SR/Bupropion SR Other: Placebo |
Phase III |
| MedlinePlus related topics: | Diabetes Obesity |
| Drug Information available for: | Naltrexone Bupropion hydrochloride Bupropion Naltrexone hydrochloride |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Phase 3 Study Comparing the Safety and Efficacy of Naltrexone SR/Bupropion SR and Placebo in Obese Subjects With Type 2 Diabetes Mellitus |
| Estimated Enrollment: | 525 |
| Study Start Date: | May 2007 |
| Estimated Study Completion Date: | May 2009 |
| Estimated Primary Completion Date: | May 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
| Group 1: Active Comparator |
Drug: Naltrexone SR/Bupropion SR
Naltrexone SR 32 mg/Bupropion SR 360 mg/day
|
| Group 2: Placebo Comparator |
Other: Placebo
Identical placebo
|
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. In previous studies in uncomplicated obesity, the combination of bupropion SR and naltrexone was generally well tolerated and,more effective than placebo alone and naltrexone alone, and generally more effective than bupropion monotherapy in producing weight loss. The purpose of the current study is to investigate the safety and efficacy of the naltrexone SR and bupropion SR combination in obese subjects with type 2 diabetes mellitus.
Eligibility
| Ages Eligible for Study: | 18 Years to 70 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations![]() |
Show 53 Study Locations |
| Orexigen Therapeutics, Inc |
| Principal Investigator: | Priscilla Hollander, MD | Baylor Endocrine Center |
More Information
| Responsible Party: | Orexigen Therapeutics, Inc ( Eduardo Dunayevich, MD ) |
| Study ID Numbers: | NB-304 |
| First Received: | May 15, 2007 |
| Last Updated: | April 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00474630 |
| Health Authority: | United States: Food and Drug Administration |
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