Effects of Three Drugs (Colesevelam HCl, Rosiglitazone, and Sitagliptin) on Control of Blood Glucose and Lipids (e.g., Cholesterol) Will be Examined in Patients With Type 2 Diabetes Whose Blood Glucose is Not Completed Controlled With the Diabetes Drug Metformin

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

Date First Received: June 7, 2007

Last Updated: April 9, 2008

Verified by: Daiichi Sankyo Inc., March 2008

Clinical Trial Phase: Phase 3 | Start Date: May 2007

Overall Status: Active, not recruiting

Estimated Enrollment: 150

Brief Summary

Official Title: “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”

Condition Keyword(s):

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

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Study Primary Completion Date: April 2008

Intervention(s) in this Clinical Trial

  • Drug: Colesevelam HCl
    • coleveselam tablets 625 mg; 6 tablets/day
  • Drug: colesevelam tablets
    • 625mg tablets
  • Drug: rosiglitazone
    • rosiglitazone tablets 4mg
  • Drug: sitagliptin phosphate
    • sitagliptin phosphate tablets 100mg/day

Arms, Groups and Cohorts in this Clinical Trial

  • Experimental: 1
    • colesevelam tablets 625 mg
  • Active Comparator: 2
    • rosiglitazone maleate 4mg
  • Active Comparator: 3
    • sitagliptin phosphate tablets

Outcome Measures for this Clinical Trial

Primary Measures

  • Change in HbA1c from baseline to Week 16 endpoint
    • Time Frame: 16 weeks
      Safety Issue?: No

Secondary Measures

  • Change in HbA1c from baseline to week 8; change in FPG from baseline to weeks 8 and 16; Change in fasting insulin levels from baseline to weeks 8 and 16
    • Time Frame: 8 weeks and 16 weeks
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

Inclusion Criteria:

  • HbA1C 7.0 % to 10.0% on metformin monotherapy; may be withdrawn from other (non-metformin) drugs if HbA1C is 6.5% to 9.5 % at screening.

Exclusion Criteria:

  • Subjects currently treated with a thiazolidinedione are excluded.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Sponsor Information

Lead Sponsor: Daiichi Sankyo Inc.

Additional Information

Information obtained from ClinicalTrials.gov on October 10, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00484419

Study ID Number: Wel-409

ClinicalTrials.gov Identifier: NCT00484419

Health Authority: United States: Food and Drug Administration

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