THERAPEUTIC BENEFIT OF BENFLUOREX IN TYPE-II DIABETIC-PATIENTS TREATED WITH SULFONYLUREAS

The objective of this study was to evaluate the effect of benfluorex i n type II diabetic patients already treated with sulfonylureas (SU) in a randomized placebo-controlled trial. After a 4-week placebo run-in, 68 patients (49 men and 19 women; age range 40-70 years; known durati on of diabetes 0.5-19 years) were randomized to double-blind 12-week t reatment with benfluorex (B) or placebo (P). Primary end points were H bA(1c) and fasting blood glucose (FBG). Secondary end points were gluc ose tolerance (meal test over 120 min), plasma insulin, C-peptide, and lipid profile. Results were analyzed using both intention-to-treat an alysis (ITT) in patients completing at least one treatment visit and p er protocol analysis in those completing the whole study. There were n o baseline differences between the two groups in any study parameter. Fifty-eight patients completed the study (28 B, 30 P), and 66 patients (33 B, 33 P) were eligible for ITT analysis. Over the 12-week treatme nt period, FBG decreased by 14.9% in the B group (-1.39 mmol/L, p < 0. 001), and 3.2% in the P group (-0.28 mmol/L, NS) according to the ITT analysis and by 17.4% (p < 0.001) and 3.8% (NS), respectively, in the per protocol analysis. The difference in FBG outcome between the two g roups was significant (p = 0.009 and p = 0.004, respectively). In pati ents completing the study, mean HbA(1c) decreased in the B group (-0.6 6%, p = 0.005) and remained stable in the P group (+0.14%, NS). HbA(1c ) outcome differed between the two groups (p = 0.007). The decrease in AUC(glucose) was greater in the B group than in the P group (-210 +/- 220 versus -60 +/- 270 mmol/L x 120 min, p = 0.026). Plasma insulin a nd C-peptide changes did not differ between the two groups. Low-densit y lipoprotein (LDL) cholesterol decreased in B patients and was stable in P patients (-0.43 versus -0.05 mmol/L, p = 0.026). Of the 68 rando mized patients, six on B and four on P reported at least one adverse e vent, causing dropout in five and two patients, respectively. In concl usion, benfluorex is an effective agent for combination therapy in typ e II diabetic patients poorly controlled on SUs alone.