A Study of the Effect of Ezetimibe on Glucose Metabolism in Type 2 Diabetics With Hypercholesterolemia (P06541)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01611883
First received: June 1, 2012
Last updated: December 9, 2014
Last verified: December 2014
Results First Received: December 9, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Hypercholesterolemia
Interventions: Drug: Ezetimibe
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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Ezetimibe 10 mg oral dose once daily for 24 weeks
Placebo Placebo to match ezetimibe orally once daily for 24 weeks

Participant Flow:   Overall Study
    Ezetimibe     Placebo  
STARTED     75     77  
COMPLETED     74     76  
NOT COMPLETED     1     1  
Adverse Event                 1                 1  



  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.
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Reporting Groups
  Description
Ezetimibe 10 mg oral dose once daily for 24 weeks
Placebo Placebo to match ezetimibe orally once daily for 24 weeks
Total Total of all reporting groups

Baseline Measures
    Ezetimibe     Placebo     Total  
Number of Participants  
[units: participants]
  75     77     152  
Age  
[units: years]
Mean (Standard Deviation)
  59.3  (10.8)     60.0  (9.7)     59.6  (10.2)  
Gender  
[units: Participants]
     
Female     29     29     58  
Male     46     48     94  



  Outcome Measures
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1.  Primary:   Change in Glycated Hemoglobin (HbA1c) From Baseline   [ Time Frame: Baseline and Week 24 ]

2.  Secondary:   Change in Glycoalbumin From Baseline   [ Time Frame: Baseline and Week 24 ]

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

4.  Secondary:   Percentage of Participants With Adverse Event (AE) "Exacerbation of Diabetes"   [ Time Frame: up to 24 weeks ]

5.  Secondary:   Percentage of Participants With Changes in Diabetes Medications Due to Worsening of Diabetes   [ Time Frame: Up to 24 weeks ]

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

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

8.  Secondary:   Percent Change in Triglycerides From Baseline   [ Time Frame: Baseline and Week 24 ]

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

10.  Secondary:   Percent Change in Non–HDL-cholesterol From Baseline   [ Time Frame: Baseline and 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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01611883     History of Changes
Other Study ID Numbers: P06541, MK-0653-367
Study First Received: June 1, 2012
Results First Received: December 9, 2014
Last Updated: December 9, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency