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


CONCLUSIONS
Colestilan improved glycaemic control and reduced LDL cholesterol levels in patients with type 2 diabetes.
Kondo
K
K
Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan. Kondou.Kazuoki@mr.mt-pharma.co.jp
Kadowaki
T
T
D001647:Bile Acids and Salts / Q000627:therapeutic use*; D001786:Blood Glucose / Q000378:metabolism; D008078:Cholesterol, LDL / Q000097:blood*; D003924:Diabetes Mellitus, Type 2 / Q000097:blood / Q000188:drug therapy*; D004311:Double-Blind Method; D005215:Fasting; D005260:Female; D006442:Glycated Hemoglobin / Q000378:metabolism*; D006801:Humans; D007004:Hypoglycemic Agents / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome
D001647:Bile Acids and Salts; D001786:Blood Glucose; D008078:Cholesterol, LDL; D006442:Glycated Hemoglobin; D007004:Hypoglycemic Agents; C106574:cholebine