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:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01590771
First received: May 1, 2012
Last updated: April 16, 2015
Last verified: April 2015
Results First Received: April 16, 2015  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, 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  
Number of Participants  
[units: participants]
  249     249     498  
Age  
[units: Years]
Mean (Standard Deviation)
  57.5  (9.5)     56.5  (9.3)     57.0  (9.4)  
Gender  
[units: Participants]
     
Female     132     117     249  
Male     117     132     249  
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)  
Fasting plasma glucose (FPG) [2]
[units: mg/dL]
Mean (Standard Deviation)
  181.5  (40.9)     179.8  (40.7)     180.6  (40.8)  
[1] Sitagliptin, n=248; placebo, n=249; total, n=497
[2] Sitagliptin, n=249; placebo, n=249; total, n=498



  Outcome Measures
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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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01590771     History of Changes
Other Study ID Numbers: 0431-253
Study First Received: May 1, 2012
Results First Received: April 16, 2015
Last Updated: April 16, 2015
Health Authority: China: Food and Drug Administration