OBJECTIVE -In this study, we evaluated the efficacy of sibutramine in combination with hypoglycemic drugs in obese type 2 diabetic women whose glucose levels were poorly regulated.RESEARCH DESIGN AND METHODS -Female patients with type 2 diabetes, poorly controlled glucose levels, and HbA 1c Ͼ8% were randomly assigned to one of two groups. In addition to their prescribed hypoglycemic agents (maximum doses of sulfonylureas and metformin), one group (n ϭ 30) received a placebo twice daily for 6 months and the other (n ϭ 30) received sibutramine 10 mg b.i.d. for the same period.RESULTS -One patient in the sibutramine group was excluded during the study period because of hypertension; thus, a total of 29 data sets were analyzed for this group. In the placebo group, five patients had to be excluded because of low treatment efficacy, leaving a total of 25 who completed the study. Comparing the changes that occurred over 6 months in the sibutramine and placebo groups, the former showed significantly greater reductions in fasting blood glucose (P Ͻ 0.0001), second-hour postprandial blood glucose (P Ͻ 0.0001), insulin resistance (P Ͻ 0.0001), waist circumference (P Ͻ 0.0001), BMI (P Ͻ 0.0001), HbA 1c (P Ͻ 0.0001), diastolic blood pressure, pulse rate, uric acid levels, and all elements of the lipid profile except HDL cholesterol and apolipoprotein A1.CONCLUSIONS -The addition of sibutramine to oral hypoglycemic therapy resulted in significant weight loss and improvement in metabolic parameters in this patient group. Sibutramine is an effective adjunct to oral hypoglycemic therapy in obese women with type 2 diabetes.
Diabetes Care 24:1957-1960, 2001M ost patients with type 2 diabetes are obese, dyslipidemic, and insulin-resistant (1,2). In most cases, high doses of hypoglycemic drugs and statins or fibrates are required, and it is usually difficult to regulate metabolic parameters. Modification of dietary habits and subsequent weight loss can improve glycemic control, insulin level, and lipid profile findings (3,4); however, unfortunately, diet restriction alone usually does not lead to adequate weight loss (3,5,6).Previous studies have shown that tight glycemic control reduces the longterm complications of the disease. The U.K. Prospective Diabetes Study (UKPDS) showed that a 1% reduction in the average HbA 1c level was associated with a 21% reduction in risk for any end point related to diabetes, 37% for microvascular complications, and 14% for myocardial infarction (7,8). The subgroup analysis of the simvastatin (4S) study showed that reducing the level of LDL cholesterol decreased cardiovascular mortality in diabetic patients (9).Recent studies on dexfenfluramine and fluoxetine have revealed that weight reduction with these agents improves glucose control and reduces HbA 1c , BMI, and blood pressure (10 -12). Sibutramine is an anti-obesity drug that induces satiety and thermogenesis (13). Administration of sibutramine has been shown to reduce weight gain, lower the levels of nonesterified fatty acids, decrease hyperins...