Efficacy and Safety of Sitagliptin/Metformin Fixed-Dose Combination (FDC) Compared to Glimepiride in Participants With Type 2 Diabetes Mellitus (MK-0431A-202)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00993187
First received: October 9, 2009
Last updated: September 8, 2014
Last verified: September 2014
Results First Received: September 8, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Sitagliptin/Metformin FDC
Drug: Comparator: Glimepiride
Drug: Matching placebo to Sitagliptin/Metformin FDC
Drug: Matching placebo to glimepiride

  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/Metformin Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
Glimepiride Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.

Participant Flow:   Overall Study
    Sitagliptin/Metformin     Glimepiride  
STARTED     147     145  
Received at Least 1 Dose of Study Drug     146     144  
COMPLETED     121     108  
NOT COMPLETED     26     37  



  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.
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Reporting Groups
  Description
Sitagliptin/Metformin Participants in the Sitagliptin/Metformin Fixed- Dose Combination (Sita/Met FDC) group received tablets of Sita/Met FDC and placebo tablets matching glimepiride for 30 weeks. The dose for Sita/Met FDC was 50/500 mg twice daily (b.i.d.) starting Day 1 and increased to 50/1000 mg b.i.d. over a period of 4 weeks.
Glimepiride Participants in the Glimepiride group received 2 placebo tablets matching Sita/Met FDC and glimepiride tablets (1 mg or 2 mg) for 30 weeks. The dose for glimepiride was 1 mg once daily (q.d.) starting Day 1 and up-titrated as considered appropriate by the investigator based upon the results of participant's self-monitored blood glucose levels but not to exceed 6 mg/day.
Total Total of all reporting groups

Baseline Measures
    Sitagliptin/Metformin     Glimepiride     Total  
Number of Participants  
[units: participants]
  147     145     292  
Age  
[units: Years]
Mean ± Standard Deviation
  54.8  ± 8.5     53.1  ± 9.2     53.9  ± 8.9  
Gender  
[units: Participants]
     
Female     66     61     127  
Male     81     84     165  



  Outcome Measures
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1.  Primary:   Change From Baseline in Hemoglobin A1C (HbA1C) at Week 30   [ Time Frame: Baseline and Week 30 ]

2.  Primary:   Number of Participants Who Experienced at Least One Adverse Event (AE)   [ Time Frame: Up to 32 weeks ]

3.  Primary:   Number of Participants Who Discontinued Study Drug Due to an Adverse Event   [ Time Frame: Up to 30 weeks ]

4.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30   [ Time Frame: Baseline and Week 30 ]

5.  Secondary:   Percentage of Participants With One or More Episodes of Hypoglycemia   [ Time Frame: Up to Week 30 ]

6.  Secondary:   Change From Baseline in Body Weight at Week 30   [ Time Frame: Baseline and Week 30 ]

7.  Secondary:   Percentage of Participants With HbA1C < 7.0% at Week 30   [ Time Frame: Week 30 ]


  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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00993187     History of Changes
Other Study ID Numbers: 0431A-202, 2009_672
Study First Received: October 9, 2009
Results First Received: September 8, 2014
Last Updated: September 8, 2014
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)