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A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Insulin With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-254)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01590797
First Posted: May 3, 2012
Last Update Posted: April 21, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: January 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Sitagliptin
Drug: Placebo
Biological: Insulin
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
This study was performed with research participants at 28 study centers in China.

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 Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
Placebo Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.

Participant Flow:   Overall Study
    Sitagliptin   Placebo
STARTED   234   233 
COMPLETED   217   217 
NOT COMPLETED   17   16 
Adverse Event                4                3 
Lack of Efficacy                0                2 
Lost to Follow-up                0                1 
Protocol Violation                4                1 
Withdrawal by Subject                7                5 
Other Protocol Specified Criteria                2                4 



  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
Sitagliptin Participants treated with sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
Placebo Participants treated with placebo to sitagliptin 100 mg, once daily, for 24 weeks. All participants will be under treatment with a stable dose of insulin with or without metformin for ≥10 weeks before and throughout the study. All participants will receive placebo during the Placebo Run-in period.
Total Total of all reporting groups

Baseline Measures
   Sitagliptin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 234   233   467 
Age 
[Units: Years]
Mean (Standard Deviation)
 58.6  (8.4)   56.7  (9.1)   57.6  (8.8) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      104  44.4%      117  50.2%      221  47.3% 
Male      130  55.6%      116  49.8%      246  52.7% 


  Outcome Measures
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1.  Primary:   Change From Baseline in Hemoglobin A1C (HbA1C) Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin   [ Time Frame: Baseline and Week 24 ]

2.  Primary:   Number of Participants With One or More Adverse Events   [ Time Frame: Up to Week 26 ]

3.  Primary:   Number of Participants Discontinuing Study Medication Due to an AE   [ Time Frame: Up to Week 24 ]

4.  Secondary:   Change From Baseline in HbA1C Levels at Week 24 in Participants Receiving Insulin in Combination With Metformin   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:   Change From Baseline in 2-Hour Post Meal Glucose Levels at Week 24 in Participants Receiving Insulin Alone or in Combination With Metformin   [ 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.
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01590797     History of Changes
Other Study ID Numbers: 0431-254
First Submitted: May 1, 2012
First Posted: May 3, 2012
Results First Submitted: January 16, 2015
Results First Posted: January 27, 2015
Last Update Posted: April 21, 2017