ADDED BENFLUOREX IN OBESE INSULIN-REQUIRING TYPE-2 DIABETES

To determine the effect of benfluorex on glycaemic control in obese in sulin-requiring Type 2 diabetes, 76 patients (aged 53.8 +/- 12.8 years ) receiving insulin (greater than or equal to 0.5 IU/kg) and an approp riate low-calorie diet were evaluated after a 1-month run-in followed by a 3-month double-blind treatment period (3 tablets daily) with benf luorex(B;n = 37) vs placebo (P;n = 39). At inclusion, the B and P grou ps respectively did not differ in body weight (80.9 +/- 10.3 vs 77.2 /- 9.1 kg), body mass index (BMI) (30.1 +/- 4.6 vs 29.0 +/- 2.3 kg/m(2 )) or fasting blood glucose(11.22 +/- 4.33 vs 10.35 +/- 4.42 mmol/l). However, daily insulin dose and HbA1c levels were higher in the B grou p (59.9 +/- 18.6 vs 50.4 +/- 12.8 IU, p = 0.012; and 7.72 +/- 1.60 vs 6.96 +/- 1.27 %, p = 0.025, respectively). After 3 months of treatment , the decrease in daily insulin dose was greater in the B group (8.7 /- 10.1 vs 2.7 +/- 8.1 IU; p=0.032), with a decrease in HbA1c (-0.73 /- 1.74 %, p = 0.026), vs no change in the P group (+ 0.01 +/- 1.65 %, NS) and a tendency towards a greater decrease in fasting blood glucos e (-1.43 +/- 5.41 vs + 0.42 +/- 3.78 mmol/l respectively). Body weight and BMI were also lower in the B group(1.77 (n) over tilde 2.27 vs 0. 21 (n) over tilde 2.68 kg, p = 0.013; and 0.64 +/- 0.84 vs 0.07 +/- 1. 07 kg/m(2), p = 0.019, respectively) in parallel with the decrease in insulin dose. Triglycerides decreased in the B group vs an increase in the P group (-0.54 +/- 2.04 vs + 0.21 +/- 0.70 mmol/l;p = 0.06). To t ar cholesterol decreased within the B group (-0.47 +/- 1.01 mmol/l; p = 0.013) and vs the P group (intergroup p = 0.006). Adverse events wer e reported in 11 patients in the B group vs 5 in the P group INS), cau sing dropout in only one case (intercurrent illness, P group). Additio n of ben fluorex in obese insulin-requiring Type 2 diabetes thus enhan ces glycaemic control and lowers both daily insulin requirement and bo dy weight. Benfluorex + insulin is a valid alternative for obese patie nts who remain poorly controlled despite insulin or who require high d oses of insulin.