作者
Priscilla Hollander, Alok K Gupta, Raymond Plodkowski, Frank Greenway, Harold Bays, Colleen Burns, Preston Klassen, Ken Fujioka, COR-Diabetes Study Group
发表日期
2013/12/1
期刊
Diabetes care
卷号
36
期号
12
页码范围
4022-4029
出版商
American Diabetes Association
简介
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 …
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