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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:
Information provided by:
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00484419
First received: June 7, 2007
Last updated: June 17, 2009
Last verified: June 2009
Results First Received: April 29, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Conditions: Type 2 Diabetes
Hyperlipidemia
Interventions: Drug: Colesevelam HCl
Drug: rosiglitazone maleate
Drug: sitagliptin phosphate

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were recruited from 18 May 2007 to 14 December 2007 at 6 sites in Colombia, 7 sites in Mexico, and 20 sites in the United States of America.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects on metformin-combination therapy entered a 4-week washout period from non-metformin antidiabetic drug. Population is type 2 diabetes mellitus subjects on stable metformin regimen, who discontinued other antidiabetic drugs, glycemia not controlled, and low-density lipoprotein-C (LDL-C) >=60 mg/dL and triglycerides <500 mg/dL

Reporting Groups
  Description
Colesevelam colesevelam tablets 625 mg
Rosiglitazone rosiglitazone maleate 4mg
Sitagliptin sitagliptin phosphate tablets 100mg

Participant Flow:   Overall Study
    Colesevelam     Rosiglitazone     Sitagliptin  
STARTED     57     56     56  
COMPLETED     45     51     45  
NOT COMPLETED     12     5     11  
Adverse Event                 3                 0                 0  
Lost to Follow-up                 1                 0                 2  
Withdrawal by Subject                 3                 1                 1  
subject met discontinuation criteria                 2                 2                 4  
required restricted medication                 1                 0                 1  
Physician Decision                 1                 1                 1  
subject unable to receive medication                 1                 0                 0  
subject relocated                 0                 1                 0  
sponsor decision, randomized in error                 0                 0                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Colesevelam colesevelam tablets 625 mg
Rosiglitazone rosiglitazone maleate 4mg
Sitagliptin sitagliptin phosphate tablets 100mg
Total Total of all reporting groups

Baseline Measures
    Colesevelam     Rosiglitazone     Sitagliptin     Total  
Number of Participants  
[units: participants]
  57     56     56     169  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     45     44     46     135  
>=65 years     12     12     10     34  
Age  
[units: years]
Mean ± Standard Deviation
  56.6  ± 9.19     54.7  ± 10.92     54.8  ± 9.76     55.4  ± 9.96  
Gender  
[units: participants]
       
Female     29     33     36     98  
Male     28     23     20     71  
Region of Enrollment  
[units: participants]
       
Colombia     21     12     19     52  
Mexico     12     19     12     43  
United States     24     25     25     74  
Fasting Insulin [1]
[units: uIU/mL]
Mean ( Full Range )
  9.406  
  ( 1.63 to 47.77 )  
  9.945  
  ( 1.22 to 42.37 )  
  8.886  
  ( 1.32 to 24.02 )  
  9.396  
  ( 1.22 to 47.77 )  
Fasting Plasma Glucose [2]
[units: mg/dL]
Mean ( Full Range )
  174.5  
  ( 109 to 270 )  
  177.7  
  ( 101 to 469 )  
  180.6  
  ( 85 to 456 )  
  177.6  
  ( 85 to 469 )  
HbA1c [3]
[units: percent]
Mean ( Full Range )
  8.10  
  ( 6.8 to 9.7 )  
  8.06  
  ( 6.7 to 9.7 )  
  8.17  
  ( 6.5 to 9.9 )  
  8.11  
  ( 6.5 to 9.9 )  
[1] baseline fasting insulin
[2] baseline Fasting Plasma Glucose (FPG)
[3] baseline glycosylated hemoglobin



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 16 Endpoint   [ Time Frame: 16 weeks change = week 16 - week 0. ]

2.  Secondary:   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. ]

3.  Secondary:   Mean Percentage of Change in HbA1c From Week 0(Baseline) to Week 8   [ Time Frame: 8 weeks change = week 8- week 0. ]

4.  Secondary:   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. ]

5.  Secondary:   Change in FPG From Week 0(Baseline) to Week 16 Least Squares Mean   [ Time Frame: 16 weeks change = week 16 - week 0. ]

6.  Secondary:   Mean Change in FPG From Week 0(Baseline) to Week 8   [ Time Frame: 8 weeks change = week 8- week 0. ]

7.  Secondary:   Mean Change in FPG From Week 0(Baseline) to Week 16   [ Time Frame: 16 weeks change = week 16 - week 0. ]

8.  Secondary:   Change in Fasting Insulin From Week 0(Baseline) to Week 8 Least Squares Mean   [ Time Frame: 8 weeks change = week 8- week 0. ]

9.  Secondary:   Change in Fasting Insulin From Week 0(Baseline) to Week 16 Least Squares Mean   [ Time Frame: 16 weeks change = week 16 - week 0. ]

10.  Secondary:   Mean Change in Fasting Insulin From Week 0(Baseline) to Week 8   [ Time Frame: 8 weeks change = week 8- week 0. ]

11.  Secondary:   Mean Change in Fasting Insulin From Week 0(Baseline) to Week 16   [ Time Frame: 16 weeks change = week 16 - week 0. ]

12.  Secondary:   Change in Post-prandial Glucose From Week 0(Baseline) to Week 16 Least Squares Mean   [ Time Frame: 16 weeks change = week 16 - week 0. ]

13.  Secondary:   Mean Change in Post-prandial Glucose From Week 0(Baseline) to Week 16   [ Time Frame: 16 weeks change = week 16 - week 0. ]

14.  Secondary:   Mean Change in Post-prandial Insulin From Week 0(Baseline) to Week 16   [ Time Frame: 16 weeks change = week 16 - week 0. ]

15.  Secondary:   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. ]

16.  Secondary:   Mean Change in LDL-C From Week 0(Baseline) to Week 16   [ Time Frame: 16 weeks change = week 16 - week 0. ]

17.  Secondary:   Mean Percentage of Change in LDL-C Levels From Week 0(Baseline) to Week 16   [ Time Frame: 16 weeks change = week 16 - week 0. ]

18.  Secondary:   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. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: John Raia, Director, Professional Affairs
Organization: Daiichi Sankyo Inc.
phone: 973-630-2683
e-mail: jraia@dsus.com


No publications provided


Responsible Party: Yu-Ling Lai, Daiichi Sankyo
ClinicalTrials.gov Identifier: NCT00484419     History of Changes
Other Study ID Numbers: Wel-409
Study First Received: June 7, 2007
Results First Received: April 29, 2009
Last Updated: June 17, 2009
Health Authority: United States: Food and Drug Administration