{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,13]],"date-time":"2026-10-13T19:36:16Z","timestamp":1791920176629,"version":"4.3.4"},"reference-count":40,"publisher":"American Diabetes Association","issue":"12","license":[{"start":{"date-parts":[[2021,8,28]],"date-time":"2021-08-28T00:00:00Z","timestamp":1630108800000},"content-version":"vor","delay-in-days":2845,"URL":"http:\/\/creativecommons.org\/licenses\/by-nc-nd\/3.0\/"}],"content-domain":{"domain":["diabetesjournals.org"],"crossmark-restriction":true},"short-container-title":[],"published-print":{"date-parts":[[2013,12,1]]},"abstract":"<jats:sec>\n                    <jats:title>OBJECTIVE<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESEARCH DESIGN AND METHODS<\/jats:title>\n                    <jats:p>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 \u22655% weight loss. Secondary end points included achievement of HbA1c &amp;lt;7% (53 mmol\/mol), achievement of weight loss \u226510%, and change in HbA1c, waist circumference, fasting blood glucose, and lipids.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>RESULTS<\/jats:title>\n                    <jats:p>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 (\u22125.0 vs. \u22121.8%; P &amp;lt; 0.001) and proportion of patients achieving \u22655% weight loss (44.5 vs. 18.9%, P &amp;lt; 0.001) compared with placebo. NB also resulted in significantly greater HbA1c reduction (\u22120.6 vs. \u22120.1% [6.6 vs. 1.1 mmol\/mol]; P &amp;lt; 0.001), percent of patients achieving HbA1c &amp;lt;7% (53 mmol\/mol) (44.1 vs. 26.3%; P &amp;lt; 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.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>CONCLUSIONS<\/jats:title>\n                    <jats:p>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.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.2337\/dc13-0234","type":"journal-article","created":{"date-parts":[[2013,10,21]],"date-time":"2013-10-21T23:07:22Z","timestamp":1382396842000},"page":"4022-4029","update-policy":"https:\/\/doi.org\/10.2337\/ada-journal-policies","source":"Crossref","is-referenced-by-count":423,"title":["Effects of Naltrexone Sustained- Release\/Bupropion Sustained-Release Combination Therapy on Body Weight 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