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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:
ClinicalTrials.gov Identifier:
NCT00484419
First Posted: June 8, 2007
Last Update Posted: October 4, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Daiichi Sankyo, Inc.
June 7, 2007
June 8, 2007
April 29, 2009
June 17, 2009
October 4, 2016
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. ]
Change in HbA1c from Week 0(baseline) to Week 16 endpoint mean with standard deviation change = week 16 - week 0.
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. ]
    Change in HbA1c from Week 0(baseline)to Week 16 endpoint least squares mean with 95% confidence intervals, change = week 16 - week 0.
  • Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8 [ Time Frame: 8 weeks change = week 8- week 0. ]
    change in HbA1c from Week 0(baseline) to week 8 mean and standard deviation change = week 8 - week 0.
  • 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. ]
    change in FPG from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.
  • Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ]
    change in FPG from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.
  • Mean Change in FPG From Week 0(Baseline) to Week 8 [ Time Frame: 8 weeks change = week 8- week 0. ]
    mean change in FPG from Week 0(baseline) to Week 8 with standard deviation change = week 8 - week 0.
  • Mean Change in FPG From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ]
    change in FPG from Week 0(baseline) to week 16 mean and standard deviation change = week 16 - week 0.
  • Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean [ Time Frame: 8 weeks change = week 8- week 0. ]
    change in fasting insulin from Week 0(baseline) to week 8 least squares mean and 95% confidence interval change = week 8 - week 0.
  • Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ]
    change in fasting insulin from Week 0(baseline) to week 16 least squares mean and 95% confidence interval change = week 16 - week 0.
  • Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8 [ Time Frame: 8 weeks change = week 8- week 0. ]
    mean change in fasting insulin from Week 0(baseline) to week 8 with standard deviation change = week 8 - week 0.
  • Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ]
    mean change in fasting insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
  • Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean [ Time Frame: 16 weeks change = week 16 - week 0. ]
    change in post-prandial glucose from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.
  • Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ]
    mean change in post-prandial glucose from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
  • Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ]
    mean change in post-prandial insulin from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
  • 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. ]
    change in LDL-C from Week 0(baseline) to week 16 least squares mean with 95% confidence intervals change = week 16 - week 0.
  • Mean Change in LDL-C From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ]
    mean change in LDL-C from Week 0(baseline) to week 16 with standard deviation change = week 16 - week 0.
  • Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16 [ Time Frame: 16 weeks change = week 16 - week 0. ]
    mean percent change in LDL-C levels from Week 0(baseline) to Week 16 mean with standard deviation change = week 16 - week 0.
  • 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. ]
    percent change in LDL-C levels from Week 0(baseline) to Week 16 (least squares mean with 95% confidence interval)
- 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
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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
Intervention Model: Parallel Assignment
Masking: None (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.
Sexes Eligible for Study: All
18 Years to 80 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00484419
Wel-409
Not Provided
Not Provided
Not Provided
Daiichi Sankyo, Inc.
Daiichi Sankyo, Inc.
Not Provided
Not Provided
Daiichi Sankyo, Inc.
August 2016

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