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 (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00484419
First received: June 7, 2007
Last updated: August 23, 2016
Last verified: August 2016
Results First Received: April 29, 2009  
Study Type: Interventional
Study Design: Allocation: Randomized;   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 
Overall Participants Analyzed 
[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) 
[1] baseline fasting insulin
Fasting Plasma Glucose [1] 
[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) 
[1] baseline Fasting Plasma Glucose (FPG)
HbA1c [1] 
[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 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
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  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



Responsible Party: Daiichi Sankyo Inc.
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: August 23, 2016