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Welchol as Monotherapy for Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier:
NCT00789737
First received: November 10, 2008
Last updated: January 24, 2014
Last verified: January 2014
Results First Received: December 4, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Welchol
Drug: Placebo

  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
From January 2009 through July 2011, subjects were recruited from medical clinics, private practice and research clinics.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment

There was a 2-week placebo lead-in prior to randomization to treatment arm. Participants were excluded if two or more fasting blood glucose readings >240 mg/dL occurred during lead-in.

Subjects were excluded if there had been oral antidiabetic, significant insulin, or bile acid sequestrant therapy in the 3 months prior to screening.


Reporting Groups
  Description
Welchol

Welchol 625mg tablets

Welchol : Welchol 625mg tablets

Placebo

placebo

Placebo : placebo


Participant Flow:   Overall Study
    Welchol   Placebo
STARTED   176   181 
COMPLETED   128   126 
NOT COMPLETED   48   55 
Withdrawal by Subject                13                22 
Lost to Follow-up                10                14 
Adverse Event                8                8 
Protocol Violation                3                0 
Lack of Efficacy                3                0 
hyperglycemia that met protocol-specifie                0                4 
not specified                11                7 



  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
Welchol

Welchol 625mg tablets

Welchol : Welchol 625mg tablets

Placebo

placebo

Placebo : placebo

Total Total of all reporting groups

Baseline Measures
   Welchol   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 176   181   357 
Age 
[Units: Participants]
     
<=18 years   0   0   0 
Between 18 and 65 years   165   167   332 
>=65 years   11   14   25 
Age 
[Units: Years]
Mean (Standard Deviation)
 52.6  (10.25)   51.8  (10.52)   52.2  (10.38) 
Gender 
[Units: Participants]
     
Female   82   92   174 
Male   94   89   183 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   86   80   166 
Not Hispanic or Latino   90   101   191 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   12   11   23 
Asian   12   8   20 
Native Hawaiian or Other Pacific Islander   1   0   1 
Black or African American   27   29   56 
White   122   131   253 
More than one race   0   0   0 
Unknown or Not Reported   2   2   4 
Region of Enrollment 
[Units: Participants]
     
United States   176   181   357 
Body mass index 
[Units: Kg/m*2]
Mean (Standard Deviation)
 32.0  (6.5)   31.8  (4.94)   31.9  (5.75) 
baseline body mass index category [1] 
[Units: Participants]
     
<30 kg/m*2   68   66   134 
>= 30 kg/m*2   108   115   223 
[1] number >= 30 kg/m*2 and number <30 kg/m*2
Duration of type 2 diabetes 
[Units: Years]
Mean (Standard Deviation)
 4.3  (4.69)   3.9  (4.39)   4.1  (4.54) 


  Outcome Measures
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1.  Primary:   Percent Change in Hemoglobin A1c   [ Time Frame: 24 week ]

2.  Secondary:   Change in Fasting Plasma Glucose   [ Time Frame: from baseline to 24 weeks ]

3.  Secondary:   % Subjects With a Decrease in HbA1c of >= 0.7 Percentage Units   [ Time Frame: 24 weeks ]

4.  Secondary:   % Subjects Achieving an HbA1C Goal of <7.0   [ Time Frame: 24 weeks ]

5.  Secondary:   % Subjects With a Decrease in FPG >=30 mg/dL   [ Time Frame: from baseline to 24 weeks ]

6.  Secondary:   Changes in Total Cholesterol [TC]   [ Time Frame: from baseline to 24 weeks ]

7.  Secondary:   Changes in Low Density Lipoprotein Cholesterol [LDL-C]   [ Time Frame: from baseline to 24 weeks ]

8.  Secondary:   Changes in High Density Lipoprotein Cholesterol [HDL-C]   [ Time Frame: from baseline to 24 weeks ]

9.  Secondary:   Changes in Non-HDL-C   [ Time Frame: from baseline to 24 weeks ]

10.  Secondary:   Changes in Triglycerides [TG]   [ Time Frame: from baseline to 24 weeks ]

11.  Secondary:   Changes in Apolipoprotein A-I (apoA-I)   [ Time Frame: from baseline to 24 weeks ]

12.  Secondary:   Changes in Apolipoprotein B (apoB)   [ Time Frame: from baseline to 24 weeks ]

13.  Secondary:   Change in Postprandial Plasma Glucose, 2 Hours After a Meal Tolerance Test   [ Time Frame: from baseline to 24 weeks ]


  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: Director Metabolic Clinical Development
Organization: Daiichi Sankyo Pharma Development
phone: 732-590-5000



Responsible Party: Daiichi Sankyo Inc.
ClinicalTrials.gov Identifier: NCT00789737     History of Changes
Other Study ID Numbers: WEL-305
Study First Received: November 10, 2008
Results First Received: December 4, 2013
Last Updated: January 24, 2014
Health Authority: United States: Food and Drug Administration