We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

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


  Baseline Characteristics
  Hide Baseline Characteristics

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 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) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      130  53.9%      148  61.9%      278  57.9% 
Male      111  46.1%      91  38.1%      202  42.1% 
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
  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
  Hide Limitations and Caveats

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
No text entered.


  More Information