Colestilan monotherapy significantly improves glycaemic control and LDL cholesterol levels in patients with type 2 diabetes: a randomized double-blind placebo-controlled study
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1Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan. Kondou.Kazuoki@mr.mt-pharma.co.jp
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)> or =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.
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