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

Sponsor:	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

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

Resource links provided by NLM:

Genetics Home Reference related topics: 6q24-related transient neonatal diabetes mellitus

MedlinePlus related topics: Diabetes Diabetes Type 2 Obesity

Drug Information available for: Naltrexone Naltrexone hydrochloride Bupropion hydrochloride Bupropion

U.S. FDA Resources

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
Study Completion Date:	May 2009
Primary Completion Date:	May 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Group 1	Drug: Naltrexone SR/Bupropion SR Naltrexone SR 32 mg/Bupropion SR 360 mg/day
Placebo Comparator: Group 2	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

Sponsors and Collaborators

Orexigen Therapeutics, Inc

Investigators

Principal Investigator:

Priscilla Hollander, MD

Baylor Endocrine Center

More Information

No publications provided

Responsible Party:	Eduardo Dunayevich, MD, Orexigen Therapeutics, Inc
ClinicalTrials.gov Identifier:	NCT00474630 History of Changes
Other Study ID Numbers:	NB-304
Study First Received:	May 15, 2007
Last Updated:	January 22, 2010
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
Naltrexone
Bupropion
Narcotic Antagonists

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

ClinicalTrials.gov processed this record on February 12, 2012