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Liraglutide, a glucagon-like peptide-1 analogue, has been shown have potential benefit for weight management at a once-daily dose of 3. Full Text of Background We conducted a week, double-blind trial involving patients who did not have type 2 diabetes and who had a body-mass index BMI; the weight in kilograms divided by the square of the height in meters of at least 30 or a BMI of at least 27 if they had treated or untreated dyslipidemia or hypertension.
We randomly assigned patients in a ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3. Full Text of Methods At week dr chang weight loss columbia sc, patients in the liraglutide group had lost a mean of 8. A total of The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea. Serious events occurred in 6. Full Text of Results In this study, 3. Funded by Novo Nordisk; SCALE Obesity and Prediabetes NN ClinicalTrials.
Full Text of Discussion The increase in the rate of obesity, a chronic disease with serious health consequences, largely explains the recent tripling in the prevalence of type 2 diabetes. We conducted the study from June 1,through March 18,at sites in 27 countries in Europe, North America, South America, Asia, Africa, and Australia. The trial protocol was approved by local ethics committees or institutional review boards and is available with the full text of this article at NEJM.
The trial was conducted in accordance with the principles of the Declaration of Dr chang weight loss columbia sc 13 and Good Clinical Practice guidelines. All the authors were involved in the design or conduct of the study and the preparation of the manuscript, including the decision to submit it for publication, and all attest to the accuracy and completeness of data and the data analyses. The sponsor, Novo Nordisk, planned and performed the statistical analyses, provided editorial and writing assistance, and provided the trial drugs.
The trial enrolled patients 18 years of age or older who had stable body weight and a body-mass index BMI; the weight in kilograms divided by the square of the height in meters of 30 or higher, or 27 or higher if the patient had treated or untreated dyslipidemia or hypertension Table S1 in the Supplementary Appendixavailable at NEJM. All the patients provided written informed consent before participation.
Key exclusion criteria were type 1 or 2 diabetes, the use of medications that cause clinically significant weight gain or loss, previous bariatric surgery, a history of pancreatitis, a history of major depressive or other severe psychiatric disorders, and a family or personal history of multiple endocrine neoplasia type 2 or familial medullary dr chang weight loss columbia sc carcinoma.
Details of the eligibility and exclusion criteria are provided in the Supplementary Appendix. Randomization was performed with the use of a telephone or Web-based system provided by the sponsor. Eligible patients were randomly assigned, in a ratio, to receive once-daily subcutaneous injections of liraglutide, starting at a dose of 0.
S1 in the Supplementary Appendix. Patients, investigators, and the sponsor were unaware of the study-group assignments. Liraglutide and placebo were provided in FlexPen devices Novo Nordisk. After 56 weeks, patients in the liraglutide group who did not have prediabetes at screening were randomly assigned in a ratio to continue receiving liraglutide or to switch to placebo for px903 diet plan weeks to assess whether efficacy was maintained after discontinuation of liraglutide treatment and whether there were safety issues related to discontinuation.
Patients in the placebo group continued to receive placebo. Patients were evaluated every 2 weeks until week 8; thereafter, patients were evaluated every 4 weeks until week 44 and were evaluated again at weeks 50, 56, 58, 60, 64, 68, and All patients received standardized counseling on lifestyle modification approximately monthly see the Supplementary Appendix.
Secondary end points included changes from baseline in BMI, waist circumference, glycemic control variables, cardiometabolic biomarkers, and health-related quality of life.
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