This study was an open-label, randomized, case-control, crossover study of colestimide 3 g/day in 40 Japanese patients with type 2 diabetes mellitus (T2D) and hypercholesterolemia. Patients were assigned to the colestimide group in which pravastatin and colestimide were administered orally and to the statin group in which pravastatin alone was administered orally. The principal outcome measures were serum lipid levels, fasting plasma glucose level in the early morning, hemoglobin A1c (HbA1c), visceral fat area (VFA), and serum 1,5-anhydroglucitol (1,5-AG) level.
Serum low-density lipoprotein cholesterol levels significantly decreased from 113卤38 mg/dl at baseline to 90卤20 mg/dl (P=.009) at week 12 of colestimide administration. HbA1c significantly decreased from 7.4%卤0.9%at baseline to 6.9%卤0.9%(P=.001) at week 12 of colestimide administration. Serum 1,5-AG levels increased from 9.4卤10.1 渭g/ml to 12.4卤9.5 渭g/ml (P=.05) at week 12 of colestimide administration. The statin group showed no significant changes in lipids and 1,5-AG. However, 螖VFA was inversely correlated with 螖cholic acid, and multivariate analysis revealed that 螖VFA was a significant explanatory variable.
Colestimide holds promise not only for the treatment of hypercholesterolemia but also for the possible improvement of T2D and visceral fat obesity.