A randomized double-blind study of
benfluorex (150 mg x 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/ m2], moderate fasting
hyperglycemia (fasting
blood glucose 9 +/- 0.5 mmol/L, HbA1c 6.7 +/- 0.9%) and moderate
hyperinsulinemia (18.6 +/- 3.0 microU/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, HbA1c, 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, HbA1c 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 postprandial glycemia. The decreases in fasting
blood glucose and insulinemia 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 microU/mL, respectively), but were not statistically significant. The increase in the
insulin sensitivity index (Kitt) 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 HbA1c and mean daily
blood glucose, and tends to lower insulinemia.