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A Study in China Evaluating the Safety and Efficacy of Adding Sitagliptin to Stable Therapy With Sulfonylurea With or Without Metformin in Participants With Type 2 Diabetes Mellitus (T2DM) (MK-0431-253)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01590771
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: April 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
Drug: Gliclazide
Drug: Glimepiride
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
All participants randomized population.

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 once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
Placebo Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.

Participant Flow:   Overall Study
    Sitagliptin   Placebo
STARTED   249   249 
COMPLETED   230   210 
NOT COMPLETED   19   39 
Other Protocol Specified Criteria                5                14 
Withdrawal by Subject                8                15 
Protocol Violation                1                2 
Lost to Follow-up                1                1 
Lack of Efficacy                1                0 
Adverse Event                3                7 



  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 Sitagliptin 100 mg once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
Placebo Matching placebo once daily for 24 weeks. Participants continued pre-study gliclazide or glimepiride with or without metformin for ≥10 weeks before and throughout the study.
Total Total of all reporting groups

Baseline Measures
   Sitagliptin   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 249   249   498 
Age 
[Units: Years]
Mean (Standard Deviation)
 57.5  (9.5)   56.5  (9.3)   57.0  (9.4) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      132  53.0%      117  47.0%      249  50.0% 
Male      117  47.0%      132  53.0%      249  50.0% 
Hemoglobin A1c (A1C) 
[Units: Percent of glycosylated hemoglobin (A1C)]
Mean (Standard Deviation)
 8.61  (1.06)   8.48  (0.91)   8.55  (0.99) 
2-hour post meal glucose (2-hr PMG) [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 296.5  (68.0)   290.2  (72.4)   293.4  (70.2) 
[1] Sitagliptin, n=248; placebo, n=249; total, n=497
Fasting plasma glucose (FPG) [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 181.5  (40.9)   179.8  (40.7)   180.6  (40.8) 
[1] Sitagliptin, n=249; placebo, n=249; total, n=498


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin   [ Time Frame: Baseline and Week 24 ]

2.  Primary:   Number of Participants Who Experienced an Adverse Event   [ Time Frame: Up to 26 weeks ]

3.  Primary:   Number of Participants Who Discontinued Study Drug Due to an Adverse Event   [ Time Frame: Up to 24 weeks ]

4.  Secondary:   Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin   [ Time Frame: Baseline and Week 24 ]

5.  Secondary:   Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone or in Combination With Metformin   [ Time Frame: Baseline and Week 24 ]

6.  Secondary:   Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin   [ Time Frame: Baseline and Week 24 ]

7.  Secondary:   Change From Baseline in A1C Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone   [ Time Frame: Baseline and Week 24 ]

8.  Secondary:   Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and a Sulfonylurea in Combination With Metformin   [ Time Frame: Baseline and Week 24 ]

9.  Secondary:   Change From Baseline in 2-hr PMG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone   [ Time Frame: Baseline and Week 24 ]

10.  Secondary:   Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea in Combination With Metformin   [ Time Frame: Baseline and Week 24 ]

11.  Secondary:   Change From Baseline in FPG Levels at Week 24 in Participants Receiving Sitagliptin and Sulfonylurea Alone   [ 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.
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01590771     History of Changes
Other Study ID Numbers: 0431-253
First Submitted: May 1, 2012
First Posted: May 3, 2012
Results First Submitted: April 16, 2015
Results First Posted: May 4, 2015
Last Update Posted: April 21, 2017