Evaluation of Continuous Glucose Monitoring in Participants With Type 2 Diabetes Mellitus (MK-0000-258 AM2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01537120
First received: December 22, 2011
Last updated: August 26, 2014
Last verified: August 2014
Results First Received: September 25, 2013  
Study Type: Interventional
Study Design: Endpoint Classification: Pharmacodynamics Study;   Intervention Model: Single Group Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Diagnostic
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Vildagliptin
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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
After enrollment, participants previously treated with both metformin and sulfonylurea, discontinued sulfonylurea usage and underwent washout of sulfonylurea over a period of 8 weeks prior to treatment. Non-washout participants were enrolled on a clinical regimen of metformin alone.

Reporting Groups
  Description
Placebo → Vildagliptin Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily

Participant Flow for 4 periods

Period 1:   Enrolled
    Placebo → Vildagliptin  
STARTED     25  
COMPLETED     25  
NOT COMPLETED     0  

Period 2:   8 Weeks Washout
    Placebo → Vildagliptin  
STARTED     25  
COMPLETED     24  
NOT COMPLETED     1  
Inclusion/exclusion criteria not met                 1  

Period 3:   3 Weeks Placebo
    Placebo → Vildagliptin  
STARTED     24  
COMPLETED     23  
NOT COMPLETED     1  
Withdrawal by Subject                 1  

Period 4:   12 Weeks Vildagliptin
    Placebo → Vildagliptin  
STARTED     23  
COMPLETED     23  
NOT COMPLETED     0  



  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
Placebo → Vildagliptin Participants received placebo tablets orally, twice a day for 3 weeks, and then over the next 12 weeks received vildagliptin 50 mg tablets orally, twice daily

Baseline Measures
    Placebo → Vildagliptin  
Number of Participants  
[units: participants]
  25  
Age  
[units: Years]
Mean ± Standard Deviation
  62  ± 5.6  
Gender  
[units: Participants]
 
Female     1  
Male     24  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   24 Hour Weighted Mean Glucose (WMG) At 2 Weeks   [ Time Frame: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment ]

2.  Secondary:   Hemoglobin A1C (HbA1C) At 2 Weeks   [ Time Frame: At 2 weeks after Placebo treatment and again at 2 weeks after Vildagliptin treatment ]

3.  Secondary:   HbA1C At 12 Weeks   [ Time Frame: At 2 weeks after Placebo treatment and again at 12 weeks after Vildagliptin treatment ]


  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: NCT01537120     History of Changes
Other Study ID Numbers: 0000-258
Study First Received: December 22, 2011
Results First Received: September 25, 2013
Last Updated: August 26, 2014
Health Authority: Netherlands: Independent Ethics Committee