A Safety and Efficacy Study Comparing Naltrexone SR/Bupropion SR and Placebo in Obese Type 2 Diabetics - Tabular View

Tracking Information

First Received Date ^ICMJE

May 15, 2007

Last Updated Date

April 19, 2008

Start Date ^ICMJE

May 2007

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in percentage of total body weight lost and percentage of subjects who achieve a weight decrease of ≥ 5% [ Time Frame: 56 weeks ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Change from baseline in percentage of total body weight lost and percentage of subjects who achieve a weight decrease of ≥ 5% [ Time Frame: 56 weeks ]

Change History

Complete list of historical versions of study NCT00474630 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Proportion of subjects who lose at least 10% of baseline body weight and who achieve a HbA1c value < 7%; Change in HbA1c; Effects on selected obesity-associated risk factors [ Time Frame: Baseline to week 56 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Proportion of subjects who lose at least 10% of baseline body weight and who achieve a HbA1c value < 7%; Change in HbA1c; Effects on selected obesity-associated risk factors,on mood and depressive symptoms and on quality of life; Adverse Events [ Time Frame: Baseline to week 56 ]

Descriptive Information

Brief Title ^ICMJE

A Safety and Efficacy Study Comparing Naltrexone SR/Bupropion SR and Placebo in Obese Type 2 Diabetics

Official Title ^ICMJE

A Phase 3 Study Comparing the Safety and Efficacy of Naltrexone SR/Bupropion SR and Placebo in Obese Subjects With Type 2 Diabetes Mellitus

Brief Summary

The purpose of this study is determine whether a combination of 2 drugs is safe and effective in treating obesity in type 2 diabetics.

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. 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.

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Condition ^ICMJE

Obesity
Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: Naltrexone SR/Bupropion SR
Other: Placebo

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

525

Estimated Completion Date

May 2009

Estimated Primary Completion Date

May 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Have body mass index(BMI) between 27 and 45 kg/m2
Diagnosed with Diabetes Mellitus type 2 and on no injectable hypoglycemic medication or inhaled insulin for more than 3 months
On oral single or combination hypoglycemic medications or no medications for the treatment of type 2 diabetes mellitus. Oral hypoglycemic medication must be stable for at least 3 months prior to randomization
Normotensive (<140/90 mm Hg); some anti-hypertensive medications are allowed
HbA1c between 7and 10%, fasting blood glucose <270 mg/ml, fasting triglycerides <400 mg/dL.
Women of child bearing potential must have a negative serum pregnancy test, must be non-lactating and agree to use effective contraception throughout the study period and 30 days after stopping study drug.

Exclusion Criteria:

Type I Diabetes Mellitus.
Subjects with "brittle-diabetes" or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months, previous history of diabetes-related dehydration leading to hospitalization, history or evidence of ketoacidosis.
Diabetes Mellitus secondary to pancreatitis or pancreatectomy.
Serious medical conditions
Loss or gain of more than 5.0 kilograms (11 pounds) within previous 3 months
Severe microvascular or macrovascular complications of diabetes
Serious psychiatric illness
In need of medications for the treatment of a psychiatric disorder (with the exception of short-term insomnia) within the previous 6 months
On prohibited concomitant medications
History of surgical or device (e.g. gastric banding) intervention for obesity
History of seizures or predisposition to seizures

Gender

Both

Ages

18 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00474630

Responsible Party

Eduardo Dunayevich, MD, Orexigen Therapeutics, Inc

Study ID Numbers ^ICMJE

NB-304

Study Sponsor ^ICMJE

Orexigen Therapeutics, Inc

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Priscilla Hollander, MD

Baylor Endocrine Center

Information Provided By

Orexigen Therapeutics, Inc

Verification Date

April 2008

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP