A randomized, controlled trial of 3.0 mg of liraglutide in weight management

BACKGROUND Obesity is a chronic disease with serious health consequences, but weight loss is difficult to maintain through lifestyle intervention alone. Liraglutide, a glucagonlike peptide-1 analogue, has been shown to have potential benefit for weight management at a once-daily dose of 3.0 mg, injected subcutaneously. METHODS We conducted a 56-week, double-blind trial involving 3731 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 2:1 ratio to receive once-daily subcutaneous injections of liraglutide at a dose of 3.0 mg (2487 patients) or placebo (1244 patients); both groups received counseling on lifestyle modification. The coprimary end points were the change in body weight and the proportions of patients losing at least 5% and more than 10% of their initial body weight. RESULTS At baseline, the mean (±SD) age of the patients was 45.1±12.0 years, the mean weight was 106.2±21.4 kg, and the mean BMI was 38.3±6.4; a total of 78.5% of the patients were women and 61.2% had prediabetes. At week 56, patients in the liraglutide group had lost a mean of 8.4±7.3 kg of body weight, and those in the placebo group had lost a mean of 2.8±6.5 kg (a difference of -5.6 kg; 95% confidence interval, -6.0 to -5.1; P<0.001, with last-observation-carried-forward imputation). A total of 63.2% of the patients in the liraglutide group as compared with 27.1% in the placebo group lost at least 5% of their body weight (P<0.001), and 33.1% and 10.6%, respectively, lost more than 10% of their body weight (P<0.001). The most frequently reported adverse events with liraglutide were mild or moderate nausea and diarrhea. Serious events occurred in 6.2% of the patients in the liraglutide group and in 5.0% of the patients in the placebo group. CONCLUSIONS In this study, 3.0 mg of liraglutide, as an adjunct to diet and exercise, was associated with reduced body weight and improved metabolic control. (Funded by Novo Nordisk; SCALE Obesity and Prediabetes NN8022-1839 ClinicalTrials.gov number, NCT01272219.)

Identifying and categorizing risks of new product development in a small technology-driven company

New product development (NPD), as a locus of the innovative potential of organizations, plays an essential role in small technology-driven company survival. To address the research gap and fulfill the companies’ needs, this survey aims to post and verify a new, simple and not time-consuming methodology for risk identification and categorization of industrial products development. To check the hypothesis that NPD project technical, cost and schedule sets of risks could be categorized as both threats and opportunities, an experiment was conducted in a small Serbian enterprise that has developed 52 innovative solid state based lighting products for outdoor lighting infrastructure. There were 69 identified risks (51 threats and 18 opportunities) that through 76 factors influence new products’ technical characteristics, schedule and cost. Explorative factor analysis was applied to reduce and compress the data and 26 composite factors were obtained as valid predictors of the NPD project results. Regarding the technical characteristics risks, the threats can be grouped into four factors consisting of six risk types, while opportunities can be grouped into two factors consisting of four risk categories. The risks influencing the schedule disturbance that act as threats are grouped into eight factors consisting of ten risk types, while those that could be used in opportunities are grouped in four factors with eight risks identified. The risks influencing the costs that threaten the project are recognized as five factors described by seven risks, while those that act as opportunities are grouped into three factors described by five variables in total