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Most individuals with type 2 diabetes also have obesity, and treatment with some diabetes medications, including insulin, can cause further weight gain. No approved chronic weight management medications have been prospectively investigated in individuals with overweight or obesity and insulin-treated type 2 diabetes. The primary objective of this study was to assess the effect of liraglutide 3.0 mg versus placebo on weight loss in this population. RESEARCH DESIGN AND METHODS Satiety and Clinical AdipositydLiraglutide Evidence (SCALE) Insulin was a 56-week, randomized, double-blind, placebo-controlled, multinational, multicenter trial in individuals with overweight or obesity and type 2 diabetes treated with basal insulin and £2 oral antidiabetic drugs. RESULTS Individuals were randomized to liraglutide 3.0 mg (n 5 198) or placebo (n 5 198), combined with intensive behavioral therapy (IBT). At 56 weeks, mean weight change was 25.8% for liraglutide 3.0 mg versus 21.5% with placebo (estimated treatment difference 24.3% [95% CI 25.5; 23.2]; P < 0.0001). With liraglutide 3.0 mg, 51.8% of individuals achieved ‡5% weight loss versus 24.0% with placebo (odds ratio 3.41 [95% CI 2.19; 5.31]; P < 0.0001). Liraglutide 3.0 mg was associated with significantly greater reductions in mean HbA 1c and mean daytime glucose values and less need for insulin versus placebo, despite a treat-to-glycemic-target protocol. More hypoglycemic events were observed with placebo than liraglutide 3.0 mg. No new safety or tolerability issues were observed. CONCLUSIONS In individuals with overweight or obesity and insulin-treated type 2 diabetes, liraglutide 3.0 mg as an adjunct to IBT was superior to placebo regarding weight loss and improved glycemic control despite lower doses of basal insulin and without increases in hypoglycemic events.

High body mass index (BMI) is known to be associated with various conditions, including type 2 diabetes (T2D), osteoarthritis, cardiovascular disease (CVD) and sleep apnoea; however, the impact of intentional weight loss on the risk of these and other outcomes is not well quantified. We examined the effect of weight loss on ten selected outcomes in a population from the UK Clinical Practice Research Datalink (CPRD) GOLD database. Included individuals were >18 years old at the index date (first BMI value between January 2001 and December 2010). They were categorised by their weight pattern between year 1 post-index and year 4 post-index (baseline period) as having stable weight (−5% to +5%) or weight loss (−25% to −10%, plus evidence of intervention or dietary advice to confirm intention to lose weight). For inclusion, individuals also required a BMI of 25.0–50.0 kg/m2 at the start of the follow-up period, during which the occurrence of ten obesity-related outcomes was recorded. Cox proportional hazard models adjusted for BMI, comorbidities, age, sex and smoking status were used to estimate relative risks for weight loss compared with stable weight. Individuals in the weight-loss cohort had median 13% weight loss. Assuming a BMI of 40 kg/m2 before weight loss, this resulted in risk reductions for T2D (41%), sleep apnoea (40%), hypertension (22%), dyslipidaemia (19%) and asthma (18%). Furthermore, weight loss was associated with additional benefits, with lower risk of T2D, chronic kidney disease, hypertension and dyslipidaemia compared with maintaining the corresponding stable lower BMI throughout the study. This study provides objective, real-world quantification of the effects of weight loss on selected outcomes, with the greatest benefits observed for the established CVD risk factors T2D, hypertension and dyslipidaemia.

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BackgroundThe aim of the study was to estimate the prevalence of depression in the population diagnosed with diabetes type 2 and to test the hypothesis that the presence of depression in such cases was associated with a) worse glycaemic control, and b) higher healthcare costs.MethodsWe conducted a cross-sectional analysis, from 1st September 2010 to 31st August 2011, among patients with type 2 diabetes aged 35 years and over in the Basque Country. It was identified how many of them had also depression. The database included administrative individual level information on age, sex, healthcare costs, other comorbidities, and values of glycaemic control (HbA1c). Deprivation index variable was used as socioeconomic measure and, to observe the coexistent pathologies, all the patients diagnoses were categorized by Adjusted Clinical Groups. We used a measure of association, a logistic and a linear regression for analysis.Results12.392 (9.8%) of type 2 diabetes patients were diagnosed with depression, being the prevalence 5.2% for males and 15.1% for females. This comorbidity was higher among the most deprived population. There was no association between the presence of depression and glycaemic control. We estimated that the comorbidity average cost per patient/year was 516€ higher than in patients with just type 2 diabetes (P < 0.001) adjusted by the other covariates.ConclusionsWe did not find any relationship between depression and glycaemic control in patients with type 2 diabetes. However, the comorbidity was associated with significantly high healthcare costs compared to that of type 2 diabetes occurring alone, after adjusting by other illness. Thus, there is a need of more precise recognition, screening and monitoring of depression among diabetic population. Evidence-based treatment for depression should be included in type 2 diabetes clinical guidelines.