Efficacy of low dose sibutramine in obese type-2 diabetes mellitus (T2DM) Indian patients

Aim: Weight loss in obese type-2 diabetes mellitus (T2DM) patients can improve glycemic control, insulin level and lipid profile. Sibutramine produces a significant weight loss and hence better glycemic control. The data on the Indian population is lacking hence we thought it worthwhile to determine the various effects of low dose sibutramine hydrochloride in obese type-2 diabetes mellitus (T2DM) patients. Methods: A 12-week prospective, open label study was conducted in 117 obese patients with T2DM who were randomized to receive either sibutramine with antidiabetic drugs or anti-diabetic drugs alone. The main outcome measures were changes in weight, BMI, waist and hip circumference, glycemic control, lipid profile and evaluation of reported adverse events. Results: At 12-weeks patients on sibutramine showed a significant (p<0.05) weight loss as compared to the control group. Improvement in HbA1c, fasting plasma glucose and 2 hour postprandial plasma glucose was significant (p<0.05) in the sibutramine group as compared to control. Sibutramine patients also showed improvements in lipid profile. Overall, sibutramine was well tolerated. Conclusions: Sibutramine in low doses produced statistically and clinically significant weight loss which was associated with improvements in glycemic and metabolic control. Sibutramine was generally well tolerated in obese T2DM patients.