Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00484419
First received: June 7, 2007
Last updated: June 17, 2009
Last verified: June 2009

June 7, 2007
June 17, 2009
May 2007
April 2008   (final data collection date for primary outcome measure)
Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as safety issue: No ]
Change in HbA1c from baseline to Week 16 endpoint [ Time Frame: 16 weeks ]
Complete list of historical versions of study NCT00484419 on ClinicalTrials.gov Archive Site
  • 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. ] [ Designated as 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. ] [ Designated as 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. ] [ Designated as 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. ] [ Designated as safety issue: No ]
  • Mean Change in FPG From Week 0(Baseline) to Week 8 [ Time Frame: 8 weeks change = week 8- week 0. ] [ Designated as safety issue: No ]
  • Mean Change in FPG From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as 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. ] [ Designated as 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. ] [ Designated as safety issue: No ]
  • Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8 [ Time Frame: 8 weeks change = week 8- week 0. ] [ Designated as safety issue: No ]
  • Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as 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. ] [ Designated as 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. ] [ Designated as 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. ] [ Designated as 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. ] [ Designated as safety issue: No ]
  • Mean Change in LDL-C From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ] [ Designated as 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. ] [ Designated as 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. ] [ Designated as safety issue: No ]
- 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
Not Provided
Not Provided
 
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Type 2 Diabetes
  • Hyperlipidemia
  • Drug: Colesevelam HCl
    coleveselam tablets 625 mg; 6 tablets/day
  • Drug: rosiglitazone maleate
    rosiglitazone tablets 4mg
  • Drug: sitagliptin phosphate
    sitagliptin phosphate tablets 100mg/day
  • Experimental: colesevelam
    colesevelam tablets 625 mg
    Intervention: Drug: Colesevelam HCl
  • Active Comparator: rosiglitazone
    rosiglitazone maleate 4mg
    Intervention: Drug: rosiglitazone maleate
  • Active Comparator: sitagliptin
    sitagliptin phosphate tablets
    Intervention: Drug: sitagliptin phosphate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
169
April 2008
April 2008   (final data collection date for primary outcome measure)

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.
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00484419
Wel-409
Not Provided
Yu-Ling Lai, Daiichi Sankyo
Daiichi Sankyo Inc.
Not Provided
Not Provided
Daiichi Sankyo Inc.
June 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP