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:	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

Resource links provided by NLM:

MedlinePlus related topics: Diabetes 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
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

Hide Study Locations

Locations

United States, Alabama
SelfCenter, PC
Fairhope, Alabama, United States, 36532
United States, Arizona
HOPE Research Institute
Phoenix, Arizona, United States, 85050
Pivotal Research Centers
Peoria, Arizona, United States, 85381
United States, Arkansas
HealthStar Research
Hot Springs, Arkansas, United States, 71913
United States, California
Affiliated Research Institute
San Diego, California, United States, 92108
Impact Clinical Trials
Beverly Hills, California, United States, 90211
Apex Research Institue
Santa Ana, California, United States, 92705
Northern California Research
Carmichael, California, United States, 98608
Advance Clinical Research Institute
Orange, California, United States, 92869
Sierra Medical Research
Fresno, California, United States, 93710
VA San Diego Healthcare System
San Diego, California, United States, 92161
United States, Connecticut
Chase Medical Research, LLC
Waterbury, Connecticut, United States, 06708
United States, Florida
University Clinical Research
Pembroke Pines, Florida, United States, 33024
Miami Research Associates
Miami, Florida, United States, 33143
LCFP Inc.
Fort Myers, Florida, United States, 33907
Suncoast Clinical Research
Palm Harbor, Florida, United States, 34684
United States, Georgia
CSRA Partners in Health, Inc
Augusta, Georgia, United States, 30909
United States, Hawaii
East-West Medical Research Institute
Honolulu, Hawaii, United States, 96814
United States, Indiana
Northwest Indiana Center for Clinical Research
Valparaiso, Indiana, United States, 46383
Welborn Clinic
Evansville, Indiana, United States, 47713
United States, Kentucky
L-Marc
Louisville, Kentucky, United States, 40213
Central Kentucky Research Associates, Inc.
Lexington, Kentucky, United States, 40509
Trover Center for Clinical Studies
Madisonville, Kentucky, United States, 42431
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Medical Research Institute
Slidell, Louisiana, United States, 70458
United States, Maryland
Health Trends Research, LLC
Baltimore, Maryland, United States, 21209
United States, Massachusetts
FutureCare Studies
Springfield, Massachusetts, United States, 01103
United States, Minnesota
Twin Cities Clinical Research
Brooklyn Center, Minnesota, United States, 55430
United States, Missouri
Radiant Research, Inc.
St. Louis, Missouri, United States, 63141
The Center for Pharmaceutical Research
Kansas City, Missouri, United States, 64114
Mercy Health Research
St. Louis, Missouri, United States, 63141
United States, Nevada
Center for Nutrition and Metabolic Diseases
Reno, Nevada, United States, 89557
United States, New Hampshire
Endocrinology & Diabetes Consultants
Dover, New Hampshire, United States, 03820
United States, New Mexico
Lovelace Scientific Resources
Albuquerque, New Mexico, United States, 87108
United States, New York
Diabetes care and Information Center
Flushing, New York, United States, 11365
Rochester Clinical Research, Inc
Rochester, New York, United States, 14609
Central New York Clinical Research
Manlius, New York, United States, 13104
United States, North Carolina
Metrolina Medical Research
Charlotte, North Carolina, United States, 28209
United States, Ohio
Wells Institute for Health Awareness
Kettering, Ohio, United States, 45429
Your Diabetes Endocrine and Nutrition Group
Mentor, Ohio, United States, 44060
Central Ohio Nutrition Center, Inc.
Columbus, Ohio, United States, 43213
Rapid Medical Research, Inc.
Cleveland, Ohio, United States, 44122
United States, South Carolina
Palmetto Medical Research
Mt. Pleasant, South Carolina, United States, 29464
Mountain View Clinical Research
Greer, South Carolina, United States, 29349
United States, Tennessee
ClinSearch
Chattanooga, Tennessee, United States, 37404
Clinical Research Associates, Inc.
Nashville, Tennessee, United States, 37203
United States, Texas
Diabetes Center of the Southwest
Midland, Texas, United States, 79705
InVisions Consultants, LLC
San Antonio, Texas, United States, 78217
The Cooper Institute
Dallas, Texas, United States, 75230
Diabetes & Glandular Disease Research Associates, Inc.
San Antonio, Texas, United States, 78229-4801
Baylor Endocrine Center
Dallas, Texas, United States, 75246
United States, Washington
Northside Internal Medicine
Spokane, Washington, United States, 99208
Summit Research Network, Inc.
Seattle, Washington, United States, 98104

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 ( Eduardo Dunayevich, MD )
Study ID Numbers:	NB-304
Study First Received:	May 15, 2007
Last Updated:	April 19, 2008
ClinicalTrials.gov Identifier:	NCT00474630 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Orexigen Therapeutics, Inc:

Obesity
Diabetes Mellitus, Type 2

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
Overweight
Body Weight
Signs and Symptoms
Sensory System Agents
Therapeutic Uses
Nutrition Disorders
Antidepressive Agents, Second-Generation

Antidepressive Agents
Obesity
Metabolic Diseases
Diabetes Mellitus
Endocrine System Diseases
Pharmacologic Actions
Bupropion
Naltrexone
Diabetes Mellitus, Type 2
Overnutrition
Dopamine Agents
Peripheral Nervous System Agents
Glucose Metabolism Disorders
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 27, 2009