Addition of benfluorex to biguanide improves glycemic control in obese non-insulin-dependent diabetes: a double-blind study versus placebo.
The oral antidiabetic benfluorex lowers insulin resistance in liver and muscle without stimulating insulin secretion; it is more effective than a biguanide in lowering insulin and triglyceride levels and does not elevate lactate. This double-blind multicenter community study compared the addition of benfluorex versus placebo to diet plus metformin in 127 uncontrolled obese type II diabetics. After a 2-month run-in on diet plus metformin, overall mean glucose was 7.7 mmol/L or greater (fasting) and/or 11 mmol/L or greater (2 h after 75-g oral glucose), with 20% or greater excess body weight [body-mass index (women/men): > or = 26.9/> or = 27.2 kg/m2). Patients were then randomized to adjuvant benflouorex (n = 63; 150 mg t.i.d.) or placebo (n = 64) for 90 days, with centralized biochemical monitoring. On benfluorex, glucose decreased from day 0 to day 90 (fasting: 8.99+/-2.76 to 7.81+/-2.32 mmol/L, p = 0.002; 2 h post-load: 16.56+/-4.49 to 15.09+/-5.09 mmol/L, p = 0.029) versus increases on placebo (intergroup p = 0.003 and p = 0.001, respectively). HbA decreased on benfluorex (7.47+/-1.44 to 7.12+/-1.13%; p = 0.013) versus no change on placebo. Basal and stimulated insulin and C peptide did not change in either group. Body weight remained similar in both groups. Tolerability was good in both groups, with no increase in hypoglycemia on benfluorex. Adjuvant behfluorex improves glycemic control in obese type II diabetics uncontrolled by diet plus metformin. The combination is safe, well-tolerated and suitable for introduction into routine practice.
Roger
P
P
Department of Endocrinology and Nutrition, Haut Lévêque Hospital, Pessac, France.
Auclair
J
J
Drain
P
P
D000328:Adult; D000368:Aged; D001067:Appetite Depressants / Q000008:administration & dosage* / Q000009:adverse effects; D001786:Blood Glucose / Q000032:analysis*; D002096:C-Peptide / Q000097:blood; D008076:Cholesterol, HDL / Q000097:blood; D003920:Diabetes Mellitus / Q000097:blood / Q000188:drug therapy*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005215:Fasting; D005260:Female; D005277:Fenfluramine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D005951:Glucose Tolerance Test; D006442:Glycated Hemoglobin / Q000032:analysis; D006801:Humans; D007004:Hypoglycemic Agents / Q000008:administration & dosage*; D000960:Hypolipidemic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D007328:Insulin / Q000097:blood; D008297:Male; D008687:Metformin / Q000008:administration & dosage*; D008875:Middle Aged; D009765:Obesity; D010919:Placebos; D013997:Time Factors; D014280:Triglycerides / Q000097:blood
D001067:Appetite Depressants; D001786:Blood Glucose; D002096:C-Peptide; D008076:Cholesterol, HDL; D005277:Fenfluramine; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; D000960:Hypolipidemic Agents; D007328:Insulin; D008687:Metformin; D010919:Placebos; D014280:Triglycerides; C001584:benfluorex