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Original Research

Effects of Naltrexone Sustained- Release/Bupropion Sustained-Release Combination Therapy on Body Weight and Glycemic Parameters in Overweight and Obese Patients With Type 2 Diabetes

  1. Priscilla Hollander, MD, PHD1⇑,
  2. Alok K. Gupta, MD2,3,
  3. Raymond Plodkowski, MD4,
  4. Frank Greenway, MD2,
  5. Harold Bays, MD5,
  6. Colleen Burns, PHD6,
  7. Preston Klassen, MD6,
  8. Ken Fujioka, MD4,
  9. for the COR-Diabetes Study Group*
  1. 1Baylor Medical Center, Dallas, Texas
  2. 2Pennington Biomedical Research Center, Louisiana State University System, Baton Rouge, Louisiana
  3. 3Our Lady of the Lake Physician Group, Baton Rouge, Louisiana
  4. 4Scripps Clinic, La Jolla, California
  5. 5Louisville Metabolic and Atherosclerosis Research Center Inc., Louisville, Kentucky
  6. 6Orexigen Therapeutics, Inc., La Jolla, California
  1. Corresponding author: Priscilla Hollander, priscilh{at}baylorhealth.edu.
Diabetes Care 2013 Dec; 36(12): 4022-4029. https://doi.org/10.2337/dc13-0234
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This article has a correction. Please see:

  • Effects of Naltrexone Sustained-Release/Bupropion Sustained-Release Combination Therapy on Body Weight and Glycemic Parameters in Overweight and Obese Patients With Type 2 Diabetes. Diabetes Care 2013;36:4022–4029 - February 01, 2014

Abstract

OBJECTIVE To assess the efficacy and safety of 32 mg naltrexone sustained-release (SR)/360 mg bupropion SR (NB) in overweight/obese individuals with type 2 diabetes with or without background oral antidiabetes drugs.

RESEARCH DESIGN AND METHODS This was a 56-week, double-blind, placebo-controlled study in which 505 patients received standardized lifestyle intervention and were randomized 2:1 to NB or placebo. Coprimary end points were percent weight change and achievement of ≥5% weight loss. Secondary end points included achievement of HbA1c <7% (53 mmol/mol), achievement of weight loss ≥10%, and change in HbA1c, waist circumference, fasting blood glucose, and lipids.

RESULTS In the modified intent-to-treat population (54% female, 80% Caucasian, and mean age 54 years, weight 106 kg, BMI 37 kg/m2, and HbA1c 8.0% [64 mmol/mol]), NB resulted in significantly greater weight reduction (−5.0 vs. −1.8%; P < 0.001) and proportion of patients achieving ≥5% weight loss (44.5 vs. 18.9%, P < 0.001) compared with placebo. NB also resulted in significantly greater HbA1c reduction (−0.6 vs. −0.1% [6.6 vs. 1.1 mmol/mol]; P < 0.001), percent of patients achieving HbA1c <7% (53 mmol/mol) (44.1 vs. 26.3%; P < 0.001), and improvement in triglycerides and HDL cholesterol compared with placebo. NB was associated with higher incidence of nausea (42.3 vs. 7.1%), constipation (17.7 vs. 7.1%), and vomiting (18.3 vs. 3.6%). No difference was observed between groups in the incidence of depression, suicidal ideation, or hypoglycemia.

CONCLUSIONS NB therapy in overweight/obese patients with type 2 diabetes induced weight loss, which was associated with improvements in glycemic control and select cardiovascular risk factors and was generally well tolerated with a safety profile similar to that in patients without diabetes.

Footnotes

  • Clinical trial reg. no. NCD00474630, clinicaltrials.gov.

  • This article contains Supplementary Data online at http://care.diabetesjournals.org/lookup/suppl/doi:10.2337/dc13-0234/-/DC1.

  • ↵* A full list of members of the COR-Diabetes Study Group can be found in the appendix.

  • Received January 28, 2013.
  • Accepted July 15, 2013.
  • © 2013 by the American Diabetes Association.

Readers may use this article as long as the work is properly cited, the use is educational and not for profit, and the work is not altered. See http://creativecommons.org/licenses/by-nc-nd/3.0/ for details.

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Effects of Naltrexone Sustained- Release/Bupropion Sustained-Release Combination Therapy on Body Weight and Glycemic Parameters in Overweight and Obese Patients With Type 2 Diabetes
Priscilla Hollander, Alok K. Gupta, Raymond Plodkowski, Frank Greenway, Harold Bays, Colleen Burns, Preston Klassen, Ken Fujioka, for the COR-Diabetes Study Group
Diabetes Care Dec 2013, 36 (12) 4022-4029; DOI: 10.2337/dc13-0234

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Effects of Naltrexone Sustained- Release/Bupropion Sustained-Release Combination Therapy on Body Weight and Glycemic Parameters in Overweight and Obese Patients With Type 2 Diabetes
Priscilla Hollander, Alok K. Gupta, Raymond Plodkowski, Frank Greenway, Harold Bays, Colleen Burns, Preston Klassen, Ken Fujioka, for the COR-Diabetes Study Group
Diabetes Care Dec 2013, 36 (12) 4022-4029; DOI: 10.2337/dc13-0234
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