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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: April 20, 2015
Last verified: April 2015
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 
Overall Participants Analyzed 
[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
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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 ]

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