| Summary: | Abstract 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 < 0.001) in the ILM and ST group, respectively. At Week 48, a weight loss of ≥5% was achieved by 50% of patients in the ILM group versus 13.3% in the ST group (p = 0.002). The decreases in BMI, waist‐to‐hip ratio and glycated hemoglobin (HbA1c) was significantly greater in the ILM versus ST group with between‐group differences of −1.63 (p ≤ 0.001), −0.03 (р ≤ 0.001) and −0.69% (p = 0.002), respectively. Conclusion A clinically significant weight reduction (≥5%) was demonstrated in patients with obesity and T2DM with use of a comprehensive LMP, along with improvements in BMI, waist‐to‐hip ratio, and HbA1c.
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