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

This study is ongoing, but not recruiting participants.

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   

U.S. FDA Resources

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

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 ]

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

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.

  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 (<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
  Contacts and Locations

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

Show 53 study locations  Show 53 Study Locations

Sponsors and Collaborators
Orexigen Therapeutics, Inc

Investigators
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

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

Study placed in the following topic categories:
Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Overweight
Body Weight
Signs and Symptoms
Dopamine
Naltrexone
Bupropion
Diabetes Mellitus, Type 2
Nutrition Disorders
Overnutrition
Endocrinopathy
Glucose Metabolism Disorders
Metabolic disorder

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Narcotic Antagonists
Physiological Effects of Drugs
Psychotropic Drugs
Pharmacologic Actions
Sensory System Agents
Therapeutic Uses
Dopamine Agents
Peripheral Nervous System Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on November 20, 2008




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