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

NCT00474630 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 505

Last updated 2014-11-21

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Orexigen Therapeutics, Inc

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-05-31
Primary Completion
2009-06-30
Completion
2009-06-30

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00474630 on ClinicalTrials.gov