Ignite Creation Date:
2024-05-05 @ 5:30 PM
Last Modification Date:
2024-10-26 @ 9:33 AM
Study NCT ID:
NCT00474630
Status:
COMPLETED
Last Update Posted:
2014-11-21
First Post:
2007-05-15
Brief Title:
A Safety and Efficacy Study Comparing Naltrexone SRBupropion SR and Placebo in Obese Subjects With Type 2 Diabetes
Sponsor:
Orexigen Therapeutics Inc
Organization:
Orexigen Therapeutics Inc
Study Overview
Official Title:
A Multicenter Randomized Double Blind Placebo Controlled Study Comparing the Safety and Efficacy of Naltrexone 32 mg Sustained Release SRBupropion 360 mg Sustained Release SR and Placebo in Obese Subjects With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| COR-Diabetes | OTHER | Orexigen Therapeutics Inc | None |