Therapeutic effect of benfluorex in type II diabetic patients on diet regimen alone

Abstract A randomized double-blind study of benfluorex (150 mg × 3 daily) versus placebo was conducted over 3 months in 32 type II diabetic patients (24 men and 8 women, aged 52 ± 8.4 years) with mild stable obesity [body-mass index (BMI) 27 ± 1.6 kg/m 2 ], moderate fasting hyperglycemia (fasting blood glucose 9 ± 0.5 mmol/L, HbA 1c 6.7 ± 0.9%) and moderate hyperinsulinemia (18.6 ± 3.0 μU/mL) when on treatment with diet alone. After a 1-month placebo run-in period, subjects were randomized to benfluorex or placebo three tablets daily. Inclusion parameters and end-of-study measures were body weight, BMI, fasting blood glucose, glycemic profile, HbA 1c , fasting insulinemia, basal and stimulated C-peptide, and an insulin tolerance test (0.1 U/kg). The groups were homogeneous at baseline, except for glycemic profile (higher postprandial glycemia in the group randomized to benfluorex). At the end of the study, the groups did not differ in body weight or BMI; however, HbA 1c decreased more with benfluorex (6.0 ± 1.0% versus 6.8 ± 0.9%, p = 0.024), as did the mean glycemic profile (7.8 ± 1.4 versus 8.5 ± 1.7 mmol/L, p itt ) was greater with benfluorex (+0.54 ± 1.4 versus +0.25 ± 1.3%/mn), but the difference was not statistically significant. The same was observed for the stimulated C-peptide. In type II diabetics with mild obesity and hyperglycemia previously managed with diet alone, benfluorex has significant long-term effect on HbA 1c and mean daily blood glucose, and tends to lower insulinemia.