K Kondo1, T Kadowaki. 1. Development Division, Mitsubishi Tanabe Pharma Corporation, Tokyo, Japan. Kondou.Kazuoki@mr.mt-pharma.co.jp
Abstract
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; placebogroup: 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.
RCT Entities:
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.
Authors: Kanami Sugimoto-Kawabata; Hiroshi Shimada; Kaoru Sakai; Kazuo Suzuki; Thomas Kelder; Elsbet J Pieterman; Louis H Cohen; Louis M Havekes; Hans M Princen; Anita M van den Hoek Journal: J Lipid Res Date: 2013-02-22 Impact factor: 5.922
Authors: Safi U Khan; Hammad Rahman; Victor Okunrintemi; Haris Riaz; Muhammad Shahzeb Khan; Sudhakar Sattur; Edo Kaluski; A Michael Lincoff; Seth S Martin; Michael J Blaha Journal: J Am Heart Assoc Date: 2019-04-02 Impact factor: 5.501