NCT00570739

Effects of Metformin Hydrochloride (HCl) in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, in Patients With Type 2 Diabetes Mellitus and the Effects of Colesevelam HCl on Lipids and Glucose on Pre-diabetic Patients.

Effects of Metformin HCl in Combination With Colesevelam HCl, Compared to Metformin HCl Alone, as Initial Therapy in Drug naïve Subjects With Type 2 Diabetes Mellitus, and the Effects of Colesevelam HCl on the Lipid Profile in Subjects With Pre Diabetes

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 502 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Not accepted

Summary

This is a 16-week double-blind, placebo-controlled (for colesevelam hydrochloride (HCl)) study in the type 2 diabetic subjects and pre-diabetic subjects. Diabetic participants will also be treated with open label, background,metformin HCl. Two-hundred sixty subjects with type 2 diabetes (T2DM) and 200 pre-diabetic subjects are planned to be be enrolled. Qualified subjects with T2DM will be randomized 1:1 to receive metformin HCl plus colesevelam HCl or metformin HCl plus placebo matching colesevelam HCl. Qualified pre-diabetic subjects will be randomized 1:1 to receive colesevelam HCl or matching placebo.

Conditions

• Type 2 Diabetes Mellitus
• Hypercholesterolemia
• Pre-diabetes

Interventions

Type	Name	Description
DRUG	Metformin HCl and Colesevelam Placebo	One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg placebo tablets once daily for 16 weeks
DRUG	Metformin HCl tablets and Colesevelam tablets	One or two Metformin HCl tablets 850 mg (depending on tolerability) and 6 colesevelam 625 mg tablets once daily for 16 weeks
DRUG	Colesevelam placebo	Six colesevelam 625 mg placebo tablets will be given once a day for 16 weeks
DRUG	Colesevelam	Six colesevelam 625 mg tablets will be given once a day for 16 weeks.

Timeline

• Start date: 2007-11-01
• Primary completion: 2009-04-01
• Completion: 2009-05-01
• First posted: 2007-12-11
• Last updated: 2010-07-27
• Results posted: 2010-07-13

Locations

31 sites across 4 countries: United States, Colombia, India, Mexico