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Study of Sitagliptin for the Treatment of Type 2 Diabetes Mellitus With Inadequate Glycemic Control on Insulin (MK-0431-260)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01462266
First received: October 27, 2011
Last updated: September 3, 2014
Last verified: September 2014
Results First Received: January 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Sitagliptin
Drug: Comparator: Placebo
Biological: Insulin Glargine
Drug: Metformin

  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
Sitagliptin Sitagliptin 100 mg administered orally once daily for 24 weeks.
Placebo Placebo to sitagliptin administered orally once daily for 24 weeks.

Participant Flow:   Overall Study
    Sitagliptin     Placebo  
STARTED     330     330  
Treated     329 [1]   329 [1]
COMPLETED     295     303  
NOT COMPLETED     35     27  
Adverse Event                 7                 6  
Death                 2                 1  
Lack of Efficacy                 0                 2  
Lost to Follow-up                 4                 3  
Non-compliance with study drug                 3                 0  
Creatinine and eGFR, excluded medication                 8                 4  
Physician Decision                 2                 5  
Protocol Violation                 1                 3  
Withdrawal by Subject                 7                 2  
Screen failure                 1                 1  
[1] One participant was randomized in error and did not receive study medication.



  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.
One participant in both the Sitagliptin group and Placebo group was randomized in error and did not receive study medication.

Reporting Groups
  Description
Sitagliptin Sitagliptin 100 mg administered orally once daily for 24 weeks.
Placebo Placebo to sitagliptin administered orally once daily for 24 weeks.
Total Total of all reporting groups

Baseline Measures
    Sitagliptin     Placebo     Total  
Number of Participants  
[units: participants]
  329     329     658  
Age  
[units: Years]
Mean ± Standard Deviation
  59.3  ± 8.9     58.3  ± 9.7     58.8  ± 9.3  
Gender  
[units: Participants]
     
Female     178     165     343  
Male     151     164     315  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Daily Insulin Dose at Week 24   [ Time Frame: Baseline and Week 24 ]

2.  Secondary:   Change From Baseline in Hemoglobin A1c (A1C) at Week 24   [ Time Frame: Baseline and Week 24 ]
  Hide Outcome Measure 2

Measure Type Secondary
Measure Title Change From Baseline in Hemoglobin A1c (A1C) at Week 24
Measure Description A1C is measured as the percentage of glycosylated hemoglobin. Change in A1C following 24 weeks of therapy (i.e., A1C at Week 24 minus A1C at baseline)
Time Frame Baseline and Week 24  
Safety Issue No  

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.
FAS population included all randomized participants who took at least one dose of study medication and had at least one measurement either at baseline or post-randomization.

Reporting Groups
  Description
Sitagliptin Sitagliptin 100 mg administered orally once daily for 24 weeks.
Placebo Placebo to sitagliptin administered orally once daily for 24 weeks.

Measured Values
    Sitagliptin     Placebo  
Number of Participants Analyzed  
[units: participants]
  329     329  
Change From Baseline in Hemoglobin A1c (A1C) at Week 24  
[units: Percent of total hemoglobin]
Least Squares Mean ( 95% Confidence Interval )
  -1.31  
  ( -1.43 to -1.20 )  
  -0.87  
  ( -0.98 to -0.75 )  

No statistical analysis provided for Change From Baseline in Hemoglobin A1c (A1C) at Week 24



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

4.  Secondary:   Percent of Participants Achieving Fasting Glucose Target at Any Time During the Study   [ Time Frame: Up to 24 weeks ]

5.  Secondary:   Time to Achieve the Fasting Glucose Target   [ Time Frame: Up 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
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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: NCT01462266     History of Changes
Other Study ID Numbers: 0431-260
Study First Received: October 27, 2011
Results First Received: January 8, 2014
Last Updated: September 3, 2014
Health Authority: United States: Food and Drug Administration