Safety and Efficacy of Sitagliptin Compared With Glimepiride in Elderly Participants With Type 2 Diabetes Mellitus (MK-0431-251 AM2)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01189890
First received: August 25, 2010
Last updated: May 12, 2014
Last verified: May 2014
Results First Received: May 8, 2013  
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 phosphate
Drug: Glimepiride
Drug: Placebo to Sitagliptin
Drug: 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 Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
Glimepiride Glimepiride 1-6 mg QD

Participant Flow:   Overall Study
    Sitagliptin     Glimepiride  
STARTED     241     239 [1]
COMPLETED     204     200  
NOT COMPLETED     37     39  
Adverse Event                 3                 4  
Lack of Efficacy                 7                 2  
Lost to Follow-up                 1                 7  
Protocol Violation                 1                 5  
Withdrawal by Subject                 15                 11  
Non Compliance                 0                 1  
Physician Decision                 5                 4  
Hyperglycemia Discontinuation Criteria                 5                 5  
[1] 3 randomized glimepiride participants did not receive study drug.



  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 Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
Glimepiride Glimepiride 1-6 mg QD
Total Total of all reporting groups

Baseline Measures
    Sitagliptin     Glimepiride     Total  
Number of Participants  
[units: participants]
  241     239     480  
Age  
[units: years]
Mean ± Standard Deviation
  70.7  ± 4.8     70.8  ± 4.9     70.7  ± 4.8  
Gender  
[units: participants]
     
Female     130     148     278  
Male     111     91     202  
Hemoglobin A1c (HbA1c) [1]
[units: Percentage¬†of¬†HbA1c]
Mean ± Standard Deviation
  7.78  ± 0.70     7.78  ± 0.67     7.78  ± 0.69  
Fasting Plasma Glucose (FPG) [2]
[units: mg/dL]
Mean ± Standard Deviation
  168.4  ± 31.2     169.7  ± 35.5     169.0  ± 33.3  
Body Weight [3]
[units: kg]
Mean ± Standard Deviation
  76.9  ± 15.1     75.4  ± 16.4     76.0  ± 15.6  
[1] The population included all randomized participants who had a baseline HbA1c, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication. Sitagliptin (n=197) and glimepiride (n=191).
[2] The population included all randomized participants who had a baseline FPG, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication. Sitagliptin (n=194) and glimepiride (n=191).
[3] All randomized participants who received at least one dose of study treatment and had a body weight measurement at baseline. Sitagliptin (n=205) and glimepiride (n=203).



  Outcome Measures
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1.  Primary:   Least Squares (LS) Mean Change From Baseline in Hemoglobin A1c (HbA1c) at Week 30   [ Time Frame: Baseline and Week 30 ]

2.  Primary:   Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30   [ Time Frame: Up to Week 30 ]

3.  Primary:   Number of Participants Experiencing An Adverse Event (AE)   [ Time Frame: Up to Week 30 ]

4.  Primary:   Number of Participants Discontinuing Study Treatment Due to An AE   [ Time Frame: Up to Week 30 ]

5.  Secondary:   LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30   [ Time Frame: Baseline and Week 30 ]
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Measure Type Secondary
Measure Title LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30
Measure Description Plasma samples were collected from participants after an overnight fast at baseline and Week 30 to determine the mean change from baseline in participant FPG.
Time Frame Baseline and Week 30  
Safety Issue No  

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.
The population included all randomized participants who had a FPG value at baseline and Week 30, did not take prohibited concomitant medications, had compliance >85%, and did not receive any incorrect study medication.

Reporting Groups
  Description
Sitagliptin Sitagliptin phosphate 100 mg once daily (QD) or 50 mg QD
Glimepiride Glimepiride 1-6 mg QD

Measured Values
    Sitagliptin     Glimepiride  
Number of Participants Analyzed  
[units: participants]
  194     191  
LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30  
[units: mg/dL]
Least Squares Mean ( 95% Confidence Interval )
  -14.5  
  ( -21.6 to -7.4 )  
  -21.2  
  ( -28.3 to -14.0 )  


Statistical Analysis 1 for LS Mean Change From Baseline in Fasting Plasma Glucose (FPG) at Week 30
Groups [1] All groups
Method [2] ANCOVA
Difference in LS Means [3] 6.7
95% Confidence Interval ( 0.7 to 12.7 )
[1] Additional details about the analysis, such as null hypothesis and power calculation:
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[2] Other relevant method information, such as adjustments or degrees of freedom:
  Controlled for treatment, eGFR stratum, age stratum, and baseline FPG.
[3] Other relevant estimation information:
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6.  Secondary:   Percentage of Participants With HbA1c <7.0% at Week 30   [ Time Frame: Week 30 ]

7.  Secondary:   Percentage of Participants With HbA1c <6.5% at Week 30   [ Time Frame: Week 30 ]

8.  Secondary:   LS Mean Change From Baseline in Participant Body Weight at Week 30   [ Time Frame: Baseline and 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: Vice President, Late Stage Development Group Leader
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: NCT01189890     History of Changes
Other Study ID Numbers: 0431-251
Study First Received: August 25, 2010
Results First Received: May 8, 2013
Last Updated: May 12, 2014
Health Authority: United States: Food and Drug Administration