TROGLITAZONE MONOTHERAPY IMPROVES GLYCEMIC CONTROL IN PATIENTS WITH TYPE-2 DIABETES-MELLITUS - A RANDOMIZED, CONTROLLED-STUDY

To assess the effects of troglitazone monotherapy on glycemic control in patients with type 2 diabetes mellitus, we carried out a 6-month, r andomized, double-blind, placebo-controlled study in 24 hospital and o utpatient clinics in the United States and Canada. Troglitazone 100, 2 00, 400, or 600 mg or placebo once daily with breakfast was administer ed to 402 patients with type 2 diabetes with fasting serum glucose (FS G) >140 mg/dL, glycosylated hemoglobin (HbA1c) >6.5%, and fasting C-pe ptide greater than or equal to 1.5 ng/mL. Prior oral hypoglycemic ther apy was withdrawn in patients who received it before the study. FSG, H bA1c, C-peptide, and serum insulin were evaluated at baseline and the end of the study. Analysis was performed on two subsets of patients ba sed on prestudy therapy: Patients treated with diet and exercise only before the study (22% of patients), and those who had been receiving s ulfonylurea therapy (78% of patients). Patients treated with 400 and 6 00 mg troglitazone had significant decreases from baseline in mean FSG and HbA1c at month 6 compared with placebo-treated patients (FSG: -51 and -60 mg/dL, respectively; H6A1c: -0.7 and -1.1%, respectively). In the diet-only subset, 600 mg troglitazone therapy resulted in a signi ficant (P < 0.05) reduction in HbA1c(-1.35%) and a significant reducti on in FSG (-42 mg/dL) compared with placebo. Patients previously treat ed with sulfonylurea therapy had significant (P < 0.05) decreases in m ean FSG with 200-600 mg troglitazone therapy compared with placebo (-4 8, -61, and -66 mg/dL, respectively). Significant (P < 0.05) decreases in mean HbA1c occurred with 400 and 600 mg troglitazone therapy at mo nth 6 (-0.8 and -1.2%, respectively) compared with placebo in this sam e subset. Significant (P < 0.05) decreases in triglycerides and free f atty acids occurred with troglitazone 400 and 600 mg, and increased hi gh-density lipoprotein occurred with 600 mg troglitazone. We conclude that troglitazone monotherapy significantly improves HbA1c and fasting serum glucose, while lowering insulin and C-peptide in patients with type 2 diabetes. Troglitazone 600 mg monotherapy is efficacious for pa tients who are newly diagnosed and have never received pharmacological intervention for diabetes.