Abstract
BackgroundObesity is common in type 2 diabetes (T2DM) and is associated with increased risk of morbidity and all-cause mortality. This analysis describes weight changes associated with insulin detemir initiation in real-life clinical practice.MethodsStudy of Once-Daily Levemir (SOLVE) was a 24-week international observational study of once-daily insulin detemir as add-on therapy in patients with T2DM receiving oral hypoglycaemic agents (OHAs).Results17,374 participants were included in the analysis: mean age 62 ± 12 years; weight 80.8 ± 17.6 kg; body mass index (BMI) 29.2 ± 5.3 kg/m2; diabetes duration 10 ± 7 years; HbA1c 8.9 ± 1.6%. HbA1c decreased by 1.3 ± 1.5% during the study, with insulin doses of 0.27 ± 0.17 IU/kg. Patients with higher BMI had higher pre-insulin HbA1c, and similar reductions in HbA1c with insulin therapy. Weight decreased from 80.8 ± 17.6 kg to 80.3 ± 17.0 kg (change of -0.6 [95% CI -0.65; -0.47] kg), with 35% of patients losing >1 kg. Patients with the highest pre-insulin BMI lost the greatest amount of weight: BMI < 25: +0.8 [95% CI: 0.6; 0.9] kg, 25 ≤ BMI < 30: -0.2 [95% CI: -0.3; -0.8] kg, 30 ≤ BMI < 35: -1.0 [95% CI: -1.1; -0.8] kg; BMI ≥ 35: -1.9 [95% CI: -2.2; -1.6] kg. Minor hypoglycaemia decreased with increasing BMI: 2.3 and 1.3 events per patient year for BMI <25 and ≥ 35, respectively.ConclusionsOverall, patients with poorly controlled T2DM achieved significant reductions in HbA1c after initiation of once-daily insulin detemir therapy, without weight gain. The favourable impact of insulin detemir on weight may not apply to other insulin preparations.Trial registrationsClinicalTrials.gov, NCT00825643 and NCT00740519
Highlights
The prevalence of type 2 diabetes mellitus (T2DM) and obesity is increasing worldwide
As the focus of this sub-analysis was the impact of insulin detemir initiation on weight and other cardiometabolic parameters, the findings presented here focuses on four baseline body mass index (BMI) subgroups (BMI
Insulin dose was not independently associated with weight loss ≥ 1 kg. This large observational study of patients with T2DM demonstrated that the initiation of once daily insulin detemir in patients already receiving oral hypoglycaemic agents (OHAs) therapy was effective in improving glycaemic control, and was associated with a low incidence of hypoglycaemia and an overall mean reduction in weight across the entire cohort
Summary
The prevalence of type 2 diabetes mellitus (T2DM) and obesity is increasing worldwide. It has become increasingly clear that physicians should give equal attention to weight management as they do to glycaemic control in patients with T2DM [4,5,6,7,8]. Excessive weight is an independent risk factor for increased morbidity and mortality in patients with T2DM [10]. Obesity is common in type 2 diabetes (T2DM) and is associated with increased risk of morbidity and all-cause mortality. This analysis describes weight changes associated with insulin detemir initiation in real-life clinical practice
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