A Study to Test the Safety and Efficacy of Sitagliptin Compared to Glimepiride in Patients With Type 2 Diabetes on a Stable Dose of Metformin (0431-803)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00701090
First received: June 17, 2008
Last updated: March 13, 2014
Last verified: March 2014
Results First Received: September 13, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Type 2 Diabetes Mellitus, Non Insulin Dependent.
Diabetes Mellitus, Non-Insulin-Dependent
Interventions: Drug: sitagliptin
Drug: Comparator: glimepiride
Drug: open-label metformin

  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

Phase III

First Patient In: 14-May-2008; Last Patient Last Visit: 27-Oct-2009; 109 study centers worldwide


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients at least 18 years of age with type 2 diabetes mellitus with inadequate glycemic control (A1C ≥6.5 and ≤9.0%) on a stable dose of metformin (at a dose of at least 1500 mg per day for at least 12 weeks) were eligible to enter the 30 week study. Up to a 2 week screening period, followed by a 2-week placebo run-in.

Reporting Groups
  Description
Sitagliptin The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
Glimepiride The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).

Participant Flow:   Overall Study
    Sitagliptin     Glimepiride  
STARTED     516     519  
COMPLETED     468     468  
NOT COMPLETED     48     51  
Adverse Event                 11                 2  
Death                 0                 1  
Lack of Efficacy                 5                 4  
Lost to Follow-up                 9                 9  
Physician Decision                 3                 4  
Protocol Violation                 2                 3  
Withdrawal by Subject                 11                 16  
Other                 7                 12  



  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 The Sitagliptin 100 mg q.d. (q.d. = once daily) group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily (blinded) in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
Glimepiride The Glimepiride group includes data from patients randomized to receive treatment starting with 1 mg oral tablets of glimepiride (blinded) up-titrated until Week 18 as needed to a maximum dose of 6 mg q.d. in addition to ongoing treatment with open-label metformin oral tablets (≥1500 mg/day).
Total Total of all reporting groups

Baseline Measures
    Sitagliptin     Glimepiride     Total  
Number of Participants  
[units: participants]
  516     519     1035  
Age  
[units: years]
Mean ± Standard Deviation
  56.3  ± 9.7     56.2  ± 10.1     56.3  ± 9.9  
Gender  
[units: participants]
     
Female     232     240     472  
Male     284     279     563  
Race/Ethnicity, Customized  
[units: participants]
     
White     297     298     595  
Black     6     6     12  
Asian     109     111     220  
American Indian/Alaska Native     25     26     51  
Other     79     78     157  
A1C (Hemoglobin A1c)  
[units: Percent]
Mean ± Standard Deviation
  7.50  ± 0.70     7.51  ± 0.76     7.50  ± 0.73  



  Outcome Measures
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1.  Primary:   Change From Baseline in HbA1c at Week 30   [ Time Frame: Week 0 to Week 30 ]

2.  Secondary:   Change From Baseline in FPG (Fasting Plasma Glucose) at Week 30   [ Time Frame: Week 0 to Week 30 ]

3.  Secondary:   Percent of Patients With at Least One Hypoglycemia Episode of Any Type at Week 30   [ Time Frame: Week 0 to Week 30 ]

4.  Secondary:   Change From Baseline in Body Weight at Week 30   [ Time Frame: Week 0 to Week 30 ]

5.  Secondary:   Percent of Patients With A1C <7.0% at Week 30   [ Time Frame: Week 30 ]

6.  Secondary:   Percent of Patients With A1C <6.5% 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: Vice President of Late Stage Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@spcorp.com


Publications of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00701090     History of Changes
Other Study ID Numbers: 0431-803, 2008_503
Study First Received: June 17, 2008
Results First Received: September 13, 2010
Last Updated: March 13, 2014
Health Authority: Austria: Federal Ministry for Health and Women