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

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: June 30, 2015
Last verified: June 2015
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 
Overall Participants Analyzed 
[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) 
[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).
Fasting Plasma Glucose (FPG) [1] 
[Units: mg/dL]
Mean (Standard Deviation)
 168.4  (31.2)   169.7  (35.5)   169.0  (33.3) 
[1] 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).
Body Weight [1] 
[Units: Kg]
Mean (Standard Deviation)
 76.9  (15.1)   75.4  (16.4)   76.0  (15.6) 
[1] 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 ]
  Hide Outcome Measure 2

Measure Type Primary
Measure Title Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30
Measure Description Symptomatic hypoglycemia was defined as an episode with clinical symptoms attributed to hypoglycemia, without regard to glucose level. Participants were instructed to complete the Hypoglycemia Assessment Log (HAL) for any symptomatic episodes he or she believed represent hypoglycemia. If a fingerstick glucose was obtained before or shortly (i.e., within a few minutes) after treating, the value was recorded in the HAL. In addition, participants were instructed to record in the HAL any fingerstick glucose values ≤70 mg/dL (≤3.9 mmol/L) regardless of the presence of clinical symptoms.
Time Frame Up to Week 30  
Safety Issue Yes  

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.
All randomized participants who received at least one dose of study treatment.

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 
Participants Analyzed 
[Units: Participants]
 241   236 
Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30 
[Units: Participants]
 2   11 


Statistical Analysis 1 for Number of Participants With an Adverse Event of Symptomatic Hypoglycemia Up to Week 30
Groups [1] All groups
Method [2] Miettinen & Nurminen
P Value [3] 0.009
Difference in Percent Incidence [4] -3.9
95% Confidence Interval -7.5 to -1.2
[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:
  Stratified by estimated glomerular filtration rate (eGFR) stratum and age stratum.
[3] Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
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[4] Other relevant estimation information:
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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 ]

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: 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: NCT01189890     History of Changes
Other Study ID Numbers: 0431-251
Study First Received: August 25, 2010
Results First Received: May 8, 2013
Last Updated: June 30, 2015
Health Authority: United States: Food and Drug Administration