THERAPEUTIC EFFECT OF BENFLUOREX IN TYPE-II DIABETIC-PATIENTS ON DIETREGIMEN ALONE

A randomized double-blind study of benfluorex (150 mg x 3 daily) versu s 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 hyperglyce mia (fasting blood glucose 9 +/- 0.5 mmol/L, HbA(1c) 6.7 +/- 0.9%) and moderate hyperinsulinemia (18.6 +/- 3.0 mu U/mL) when on treatment wi th diet alone. After a 1-month placebo run-in period, subjects were ra ndomized to benfluorex or placebo three tablets daily. Inclusion param eters and end-of-study measures were body weight, BMI, fasting blood g lucose, glycemic profile, HbA(1c), fasting insulinemia, basal and stim ulated C-peptide, and an insulin tolerance test (0.1 U/kg). The groups were homogeneous at baseline, except for glycemic profile (higher pos tprandial 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 < 0.001), including a particular decrease in po stprandial glycemia. The decreases in fasting blood glucose and insuli nemia appeared larger with benfluorex (7.7 +/- 1.3 versus 8.4 +/- 1.6 mmol/L and 13.5 +/- 4.5 versus 16.1 +/- 5.1 mu U/mL, respectively), bu t were not statistically significant. The increase in the insulin sens itivity index (K-itt) was greater with benfluorex (+0.54 +/- 1.4 versu s +0.25 +/- 1.3%/mn), but the difference was not statistically signifi cant. The same was observed for the stimulated C-peptide. In type II d iabetics with mild obesity and hyperglycemia previously managed with d iet alone, benfluorex has significant long-term effect on HbA(1c) and mean daily blood glucose, and tends to lower insulinemia.