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”

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.

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: rosiglitazone maleate
  • rosiglitazone tablets 4mg
• Drug: sitagliptin phosphate
  • sitagliptin phosphate tablets 100mg/day

Arms, Groups and Cohorts in this Clinical Trial

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

Primary Measures

• Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint
  • Time Frame: 16 weeks change = week 16 - week 0.
    Safety Issue?: No

Secondary Measures

• Mean Percentage of Change in Glycosylated Hemoglobin (HbA1c) From Week 0(Baseline) to Week 16 Endpoint Least Squares Mean
  • Time Frame: 16 weeks change = week 16 - week 0.
    Safety Issue?: No
• Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8
  • Time Frame: 8 weeks change = week 8- week 0.
    Safety Issue?: No
• Change in Fasting Plasma Glucose (FPG) From Week 0(Baseline) to Week 8 Least Squares Mean
  • Time Frame: 8 weeks change = week 8- week 0.
    Safety Issue?: No
• Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean
  • Time Frame: 16 weeks change = week 16 - week 0.
    Safety Issue?: No
• Mean Change in FPG From Week 0(Baseline) to Week 8
  • Time Frame: 8 weeks change = week 8- week 0.
    Safety Issue?: No
• Mean Change in FPG From Week 0(Baseline) to Week 16
  • Time Frame: 16 weeks change = week 16 - week 0.
    Safety Issue?: No
• Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean
  • Time Frame: 8 weeks change = week 8- week 0.
    Safety Issue?: No
• Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean
  • Time Frame: 16 weeks change = week 16 - week 0.
    Safety Issue?: No
• Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8
  • Time Frame: 8 weeks change = week 8- week 0.
    Safety Issue?: No
• Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16
  • Time Frame: 16 weeks change = week 16 - week 0.
    Safety Issue?: No
• Change in Post-Prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean
  • Time Frame: 16 weeks change = week 16 - week 0.
    Safety Issue?: No
• Mean Change in Post-Prandial Glucose From Week 0(Baseline) to Week 16
  • Time Frame: 16 weeks change = week 16 - week 0.
    Safety Issue?: No
• Mean Change in Post-Prandial Insulin From Week 0(Baseline) to Week 16
  • Time Frame: 16 weeks change = week 16 - week 0.
    Safety Issue?: No
• Change in Low-Density Lipoprotein-C(LDL-C) From Week 0(Baseline) to Week 16 Least Squares Mean
  • Time Frame: 16 weeks change = week 16 - week 0.
    Safety Issue?: No
• Mean Change in LDL-C From Week 0(Baseline) to Week 16
  • Time Frame: 16 weeks change = week 16 - week 0.
    Safety Issue?: No
• Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16
  • Time Frame: 16 weeks change = week 16 - week 0.
    Safety Issue?: No
• Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 (Least Squares Mean)
  • Time Frame: 16 weeks change = week 16 - week 0.
    Safety Issue?: No

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

Lead Sponsor: Daiichi Sankyo Inc.

Information obtained from ClinicalTrials.gov on July 02, 2009

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