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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:
ClinicalTrials.gov Identifier:
NCT01189890
First Posted: August 27, 2010
Last Update Posted: June 5, 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: May 8, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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
  Hide Participant Flow

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


  Outcome Measures
  Show All Outcome Measures

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 ]

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