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Colesevelam as Add-on to Pioglitazone Therapy for Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00789750
First Posted: November 13, 2008
Last Update Posted: June 26, 2017
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.
Results First Submitted: May 24, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Colesevelam
Drug: Placebo
Drug: Pioglitazone

  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

The safety set includes all randomized participants who took at least one dose of study medication and have at least one post-baseline safety measurement.

The intent-to-treat set includes all randomized subjects who took at least one dose of study medication, and had a baseline and at least one post-baseline HbA1c or FPG measurement.


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
There was a lead-in period that occurred after participant enrollment, but before randomization.1538 were screened, and a total of 562 participants were randomized.

Reporting Groups
  Description
Colesevelam Colesevelam tablets with pioglitazone therapy
Placebo Placebo tablets with pioglitazone therapy

Participant Flow:   Overall Study
    Colesevelam   Placebo
STARTED   280   282 
Dropped During run-in Period   6   5 
Safety Set   274   277 
Intent to Treat Set   271   276 
COMPLETED   221   222 
NOT COMPLETED   59   60 



  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.
All subjects randomized

Reporting Groups
  Description
Colesevelam Colesevelam tablets with pioglitazone therapy
Placebo Placebo tablets with pioglitazone therapy
Total Total of all reporting groups

Baseline Measures
   Colesevelam   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 280   282   562 
Age 
[Units: Participants]
Count of Participants
     
<=18 years      0   0.0%      0   0.0%      0   0.0% 
Between 18 and 65 years      220  78.6%      222  78.7%      442  78.6% 
>=65 years      60  21.4%      60  21.3%      120  21.4% 
Age 
[Units: Years]
Mean (Standard Deviation)
 56.3  (10.22)   55.6  (10.61)   56.0  (10.41) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      136  48.6%      106  37.6%      242  43.1% 
Male      144  51.4%      176  62.4%      320  56.9% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Caucasian   179   172   351 
Black   59   56   115 
Asian   23   30   53 
American Indian or Alaskan Native   16   21   37 
Native Hawaiian or Pacific Islander   0   1   1 
Other   3   2   5 
Region of Enrollment 
[Units: Participants]
     
United States   280   282   562 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Hemoglobin A1c (HbA1c) at Week 24   [ Time Frame: Baseline, Week 24 ]

2.  Secondary:   Change From Baseline in HbA1c at Week 4   [ Time Frame: Baseline, Week 4 ]

3.  Secondary:   Change From Baseline in HbA1c at Week 8   [ Time Frame: Baseline, Week 8 ]

4.  Secondary:   Change From Baseline in HbA1c at Week 16   [ Time Frame: Baseline, Week 16 ]

5.  Secondary:   Number of Participants Achieving an HbA1c Goal of <7.0%   [ Time Frame: Week 24 ]

6.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG)   [ Time Frame: Baseline, Week 24 ]

7.  Secondary:   Number of Participants With a Decrease of >= 0.7 Percent in HbA1c   [ Time Frame: Week 24 ]

8.  Secondary:   Number of Participants With a Decrease of >= 0.5 Percent in HbA1c   [ Time Frame: Week 24 ]

9.  Secondary:   Number of Participants With a Reduction in FPG of >= 30 mg/dL   [ Time Frame: Week 24 ]

10.  Secondary:   Percent Change From Baseline in Total Cholesterol (TC)   [ Time Frame: Baseline, Week 24 ]

11.  Secondary:   Percent Change From Baseline in Low-density Lipoprotein Cholesterol (LDL-C)   [ Time Frame: Baseline, Week 24 ]

12.  Secondary:   Percent Change From Baseline in High-density Lipoprotein Cholesterol (HDL-C)   [ Time Frame: Baseline, Week 24 ]

13.  Secondary:   Percent Change From Baseline in Non-HDL-C   [ Time Frame: Baseline, Week 24 ]

14.  Secondary:   Percent Change From Baseline in Triglycerides (TG)   [ Time Frame: Baseline, Week 24 ]

15.  Secondary:   Percent Change From Baseline in Apolipoprotein A-1 (Apo A-I)   [ Time Frame: Baseline, Week 24 ]

16.  Secondary:   Percent Change From Baseline in Apolipoprotein B (Apo B)   [ Time Frame: Baseline, Week 24 ]

17.  Secondary:   Change From Baseline in Fasting Insulin Levels   [ Time Frame: Baseline, Week 24 ]

18.  Secondary:   Change From Baseline in Fasting C-peptide   [ Time Frame: Baseline, Week 24 ]

19.  Secondary:   Change From Baseline in Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)   [ Time Frame: Baseline, Week 24 ]


  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: Global Clinical Leader
Organization: Daiichi Sankyo, Inc.
phone: 9089926400


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Daiichi Sankyo, Inc.
ClinicalTrials.gov Identifier: NCT00789750     History of Changes
Other Study ID Numbers: WEL-A-U306
First Submitted: November 10, 2008
First Posted: November 13, 2008
Results First Submitted: May 24, 2017
Results First Posted: June 26, 2017
Last Update Posted: June 26, 2017