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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:
NCT00474630
First received: May 15, 2007
Last updated: November 1, 2012
Last verified: November 2012
  Purpose

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


Condition Intervention Phase
Obesity
Diabetes Mellitus, Type 2
Drug: NB32
Drug: Placebo
Behavioral: Ancillary Therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Comparing the Safety and Efficacy of Naltrexone 32 mg SR/Bupropion 360 mg SR and Placebo in Obese Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Orexigen Therapeutics, Inc:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 505
Study Start Date: May 2007
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NB32

Naltrexone SR 32 mg/Bupropion SR 360 mg daily

With ancillary therapy of diet instruction, advice on behavior modification and physical activity suggestions.

Drug: NB32
Naltrexone SR 32 mg/Bupropion SR 360 mg/day
Other Names:
  • Contrave
  • Naltrexone SR 32 mg/Bupropion SR 360 mg/day
Behavioral: Ancillary Therapy
Ancillary therapy of diet instruction, advice on behavior modification and physical activity suggestions.
Placebo Comparator: Placebo

Placebo

With ancillary therapy of diet instruction, advice on behavior modification and physical activity suggestions.

Drug: Placebo
Identical placebo
Behavioral: Ancillary Therapy
Ancillary therapy of diet instruction, advice on behavior modification and physical activity suggestions.

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, 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
Criteria

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 (<145/95 mm Hg); some anti-hypertensive medications are allowed
  • HbA1c between 7and 10%, fasting blood glucose <270 mg/dl, 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00474630

  Show 53 Study Locations
Sponsors and Collaborators
Orexigen Therapeutics, Inc
Investigators
Principal Investigator: Priscilla Hollander, MD Baylor Endocrine Center
  More Information

No publications provided

Responsible Party: Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier: NCT00474630     History of Changes
Other Study ID Numbers: NB-304
Study First Received: May 15, 2007
Last Updated: November 1, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by Orexigen Therapeutics, Inc:
Obesity
Diabetes Mellitus, Type 2

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Obesity
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Bupropion
Naltrexone
Antidepressive Agents, Second-Generation
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Dopamine Uptake Inhibitors
Dopamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Uptake Inhibitors
Physiological Effects of Drugs
Narcotic Antagonists
Sensory System Agents
Peripheral Nervous System Agents

ClinicalTrials.gov processed this record on October 19, 2014