Colestilan monotherapy significantly improves glycaemic control and LDL cholesterol levels in patients with type 2 diabetes: a randomized double-blind placebo-controlled study

Aim: To evaluate the plasma glucose-reducing activity and safety of colestilan, a bile acid sequestrant, in patients with type 2 diabetes. Methods: Patients with fasting plasma glucose (FPG) 7.2-11.1 mmol/l and HbA(1c) >= 7.0% were randomly allocated in double-blind manner to receive colestilan or placebo therapy for 12 weeks. Results: A total of 183 patients entered the double-blind treatment phase. At 12 weeks, colestilan significantly reduced HbA (1c) and FPG vs. placebo by 0.9% and 1.2 mmol/l respectively (both p < 0.001). A significant (p < 0.001) 22.5% reduction of LDL cholesterol was also observed in the 172 patients evaluated (colestilan group: n = 86; placebo group: n = 86). However, no significant reduction of fasting insulin was observed (p = 0.087). No incidence of hypoglycaemia was reported in this study. Conclusion: Colestilan improved glycaemic control and reduced LDL cholesterol levels in patients with type 2 diabetes.