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

Condition(s) targeted: Obesity; Diabetes Mellitus, Type 2

Intervention: Naltrexone SR/Bupropion SR (Drug); Placebo (Other)

Phase: Phase 3

Status: Recruiting

Sponsored by: Orexigen Therapeutics, Inc

Official(s) and/or principal investigator(s):
Priscilla Hollander, MD, Principal Investigator, Affiliation: Baylor Endocrine Center

Overall contact:
Jody LaPar, Email: jlapar@metropolitanresearch.com

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

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

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

Primary outcome: Change from baseline in percentage of total body weight lost and percentage of subjects who achieve a weight decrease of ≥ 5%

Secondary outcome: 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

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.

Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.

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

Jody LaPar, Email: jlapar@metropolitanresearch.com

SelfCenter, PC, Fairhope, Alabama 36532, United States; Recruiting
Stan Self, MD, Principal Investigator

HOPE Research Institute, Phoenix, Arizona 85050, United States; Recruiting
James Vogt, MD, Principal Investigator

Pivotal Research Centers, Peoria, Arizona 85381, United States; Recruiting
Louise Taber, MD, Principal Investigator

HealthStar Research, Hot Springs, Arkansas 71913, United States; Recruiting
Troy Oxner, MD, Principal Investigator

Affiliated Research Institute, San Diego, California 92108, United States; Recruiting
Ildiko Kovacs, MD, Principal Investigator

Impact Clinical Trials, Beverly Hills, California 90211, United States; Recruiting
Lydie Hazan, MD, Principal Investigator

Apex Research Institue, Santa Ana, California 92705, United States; Recruiting
Robert Schrieman, MD, Principal Investigator

Northern California Research, Carmichael, California 98608, United States; Recruiting
Douglas Young, MD, Principal Investigator

Advance Clinical Research Institute, Orange, California 92869, United States; Recruiting
Steven Duckor, MD, Principal Investigator

Sierra Medical Research, Fresno, California 93710, United States; Recruiting
Kevin Wingert, MD, Principal Investigator

VA San Diego Healthcare System, San Diego, California 92161, United States; Not yet recruiting
Sunder Mudaliar, MD, Principal Investigator

Chase Medical Research, LLC, Waterbury, Connecticut 06708, United States; Recruiting
Joseph Soufer, MD, Principal Investigator

University Clinical Research, Pembroke Pines, Florida 33024, United States; Recruiting
Larry Gilderman, MD, Principal Investigator

Miami Research Associates, Miami, Florida 33143, United States; Recruiting
Diane Krieger, MD, Principal Investigator

LCFP Inc., Fort Myers, Florida 33907, United States; Recruiting
Angel Pietri, MD, Principal Investigator

Suncoast Clinical Research, Palm Harbor, Florida 34684, United States; Recruiting
Sanford N. Plevin, MD, Principal Investigator

CSRA Partners in Health, Inc, Augusta, Georgia 30909, United States; Recruiting
Diane Smith, MD, Principal Investigator

East-West Medical Research Institute, Honolulu, Hawaii 96814, United States; Recruiting
David Fitz-Patrick, MD, Principal Investigator

Northwest Indiana Center for Clinical Research, Valparaiso, Indiana 46383, United States; Recruiting
Robert Buynak, MD, Principal Investigator

Welborn Clinic, Evansville, Indiana 47713, United States; Recruiting
Andrew Thienemann, MD, Principal Investigator

L-Marc, Louisville, Kentucky 40213, United States; Recruiting
Harold Bays, MD, Principal Investigator

Central Kentucky Research Associates, Inc., Lexington, Kentucky 40509, United States; Recruiting
James L Borders, MD, Principal Investigator

Trover Center for Clinical Studies, Madisonville, Kentucky 42431, United States; Recruiting
Forrest Hanke, MD, Principal Investigator

Pennington Biomedical Research Center, Baton Rouge, Louisiana 70808, United States; Recruiting
Alok Gupta, MD, Principal Investigator

Medical Research Institute, Slidell, Louisiana 70458, United States; Recruiting
Adesh Jain, MD, Principal Investigator

Health Trends Research, LLC, Baltimore, Maryland 21209, United States; Recruiting
Boris Kerzner, MD, Principal Investigator

FutureCare Studies, Springfield, Massachusetts 01103, United States; Recruiting
Adnan Dahdul, MD, Principal Investigator

Twin Cities Clinical Research, Brooklyn Center, Minnesota 55430, United States; Recruiting
Normal Lunde, MD, Principal Investigator

Radiant Research, Inc., St. Louis, Missouri 63141, United States; Recruiting
Bruce Berwald, MD, Principal Investigator

The Center for Pharmaceutical Research, Kansas City, Missouri 64114, United States; Recruiting
John Ervin, MD, Principal Investigator

Mercy Health Research, St. Louis, Missouri 63141, United States; Recruiting
Timothy Smith, MD, Principal Investigator

Center for Nutrition and Metabolic Diseases, Reno, Nevada 89557, United States; Recruiting
Raymond Plodkowski, MD, Principal Investigator

Endocrinology & Diabetes Consultants, Dover, New Hampshire 03820, United States; Recruiting
Paul Tung, MD, Principal Investigator

Lovelace Scientific Resources, Albuquerque, New Mexico 87108, United States; Recruiting
Martin Conway, MD, Principal Investigator

Diabetes care and Information Center, Flushing, New York 11365, United States; Recruiting
Joseph Tibaldi, MD, Principal Investigator

Rochester Clinical Research, Inc, Rochester, New York 14609, United States; Recruiting
Mervyn Weerasinghe, MD, Principal Investigator

Central New York Clinical Research, Manlius, New York 13104, United States; Recruiting
Douglas Zmolek, MD, Principal Investigator

Metrolina Medical Research, Charlotte, North Carolina 28209, United States; Recruiting
George Raad, MD, Principal Investigator

Wells Institute for Health Awareness, Kettering, Ohio 45429, United States; Recruiting
Lawrence Koehler, MD, Principal Investigator

Your Diabetes Endocrine and Nutrition Group, Mentor, Ohio 44060, United States; Recruiting
Daniel Weiss, MD, Principal Investigator

Central Ohio Nutrition Center, Inc., Columbus, Ohio 43213, United States; Recruiting
Judy F Loper, PhD, RD, Principal Investigator

Rapid Medical Research, Inc., Cleveland, Ohio 44122, United States; Recruiting
Mira Baron, MD, Principal Investigator

Palmetto Medical Research, Mt. Pleasant, South Carolina 29464, United States; Recruiting
Richard Mills, MD, Principal Investigator

Mountain View Clinical Research, Greer, South Carolina 29349, United States; Recruiting
Phillip Snell, MD, Principal Investigator

ClinSearch, Chattanooga, Tennessee 37404, United States; Recruiting
Richard Krause, MD, Principal Investigator

Clinical Research Associates, Inc., Nashville, Tennessee 37203, United States; Recruiting
Stephen Sharp, MD, Principal Investigator

Diabetes Center of the Southwest, Midland, Texas 79705, United States; Recruiting
G. Gollapudi, MD, Principal Investigator

InVisions Consultants, LLC, San Antonio, Texas 78217, United States; Recruiting
Laura Akright, MD, Principal Investigator

The Cooper Institute, Dallas, Texas 75230, United States; Recruiting
Joseph Cleaver, MD, Principal Investigator

Diabetes & Glandular Disease Research Associates, Inc., San Antonio, Texas 78229-4801, United States; Recruiting
Sherwyn Schwartz, MD, Principal Investigator

Baylor Endocrine Center, Dallas, Texas 75246, United States; Recruiting
Priscilla Hollander, MD, Principal Investigator

Northside Internal Medicine, Spokane, Washington 99208, United States; Recruiting
Harold Cathcart, MD, Principal Investigator

Summit Research Network, Inc., Seattle, Washington 98104, United States; Recruiting
Claire Waltman, MD, Principal Investigator

Starting date: May 2007
Ending date: May 2009
Last updated: January 31, 2008