Lifestyle modification program, LIFE is LIGHT, in patients with type 2 diabetes mellitus and obesity: Results from a 48‐week, multicenter, non‐randomized, parallel‐group, open‐label study

Background Obesity is a potential risk factor for development of type 2 diabetes mellitus (T2DM). To achieve long‐term weight reduction in patients with T2DM and obesity using comprehensive lifestyle management program (LMP). Materials and methods This 48‐week interventional, multicenter, parallel‐group, open‐label study included patients aged ≥18 years with T2DM and a body mass index (BMI) of 27–40 kg/m2. The primary objective was to demonstrate a clinically significant weight reduction (≥5%) from baseline in intensive lifestyle modification (ILM) and standard treatment (ST) groups. Results The ILM group (N = 100) received recommendations for dietary and physical activity, and behavioral counseling. The ST group (N = 30) was managed in accordance with routine T2DM clinical practice. The patients in ST group were older (60.6 ± 8.9 vs. 54.6 ± 10.2 years in ILM group); overall more than 60% were women. At Week 48, the mean reduction in body weight was 5.8% (95% confidence interval [CI]: −6.9, −4.6) and 1.2% (95% CI: −2.6, 0.2) (p