NCT00484419

Effects of Colesevelam HCl, Rosiglitazone, Sitagliptin on Control of Blood Glucose and Lipids in Type 2 Diabetes Patients Whose Blood Glucose Isn't Completely Controlled With Metformin

Effects of Colesevelam HCl, Avandia® (Rosiglitazone Maleate), or JanuviaTM (Sitagliptin) on Glycemic Parameters and Lipid Profiles in Subjects With Type 2 Diabetes Mellitus Inadequately Controlled on Metformin Monotherapy

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

A 16 week open-label study with subjects receiving background metformin monotherapy. 150 subjects randomized 1:1:1 to receive 1 of the following: open-label colesevelam HCl, open label rosiglitazone, or open-label sitagliptin.

Conditions

• Type 2 Diabetes
• Hyperlipidemia

Interventions

Type	Name	Description
DRUG	Colesevelam HCl	coleveselam tablets 625 mg; 6 tablets/day
DRUG	rosiglitazone maleate	rosiglitazone tablets 4mg
DRUG	sitagliptin phosphate	sitagliptin phosphate tablets 100mg/day

Timeline

• Start date: 2007-05-01
• Primary completion: 2008-04-01
• Completion: 2008-04-01
• First posted: 2007-06-08
• Last updated: 2016-10-04
• Results posted: 2009-06-17

Locations

20 sites across 1 country: United States