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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: March 24, 2017
Last verified: March 2017
Results First Received: January 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      178  54.1%      165  50.2%      343  52.1% 
Male      151  45.9%      164  49.8%      315  47.9% 


  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 ]

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
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Time Frame Up to Week 24 + 14-day follow-up
Additional Description No text entered.

Frequency Threshold
Threshold above which other adverse events are reported   5%  

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.

Other Adverse Events
    Sitagliptin   Placebo
Total, Other (not including serious) Adverse Events     
# participants affected / at risk   121/329 (36.78%)   168/329 (51.06%) 
Gastrointestinal disorders     
Diarrhoea † 1     
# participants affected / at risk   17/329 (5.17%)   11/329 (3.34%) 
# events   19   11 
Infections and infestations     
Nasopharyngitis † 1     
# participants affected / at risk   13/329 (3.95%)   26/329 (7.90%) 
# events   16   29 
Urinary tract infection † 1     
# participants affected / at risk   14/329 (4.26%)   17/329 (5.17%) 
# events   16   18 
Metabolism and nutrition disorders     
Hypoglycaemia † 1     
# participants affected / at risk   93/329 (28.27%)   144/329 (43.77%) 
# events   358   794 
Events were collected by systematic assessment
1 Term from vocabulary, MedDRA 16.0



  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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

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: March 24, 2017