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Sitagliptin Metformin Add-on Study in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00337610
First received: June 14, 2006
Last updated: May 27, 2010
Last verified: May 2010
Results First Received: September 24, 2009  
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 (T2DM)
Interventions: Drug: sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day
Drug: comparator: placebo to match sitagliptin 100 mg q.d./metformin ≥ 1500 mg/day

  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
First Patient In: 21-Aug-2006; Last Patient Last Visit: 15-Aug-2007; Twenty-four medical clinics worldwide (12 in the United States, 2 in Israel, 3 in Mexico, 3 in Peru, and 4 in Austria).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients 18-78 years on oral single antihyperglycemic agent (AHA) (hemoglobin A1C [A1C] ≥8%) or metformin-based dual combination therapy (A1C 7.5-10.5%) were eligible to participate. Eligible patients underwent an up to 12-week metformin dose-titration/dose-stable period followed by a 2-week placebo run-in period prior to randomization.

Reporting Groups
  Description
Sitagliptin 100 mg The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
Placebo The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.

Participant Flow:   Overall Study
    Sitagliptin 100 mg     Placebo  
STARTED     96     94  
Completed Week 18     89     82  
COMPLETED     79     80  
NOT COMPLETED     17     14  
Adverse Event                 2                 2  
Death                 0                 1  
Lack of Efficacy                 6                 3  
Lost to Follow-up                 3                 3  
Withdrawal by Subject                 6                 5  



  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.
No text entered.

Reporting Groups
  Description
Sitagliptin 100 mg The Sitagliptin 100 mg group includes data from patients randomized to receive treatment with 100 mg oral tablets of sitagliptin once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
Placebo The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily in addition to ongoing treatment with open-label metformin ≥ 1500 mg/day.
Total Total of all reporting groups

Baseline Measures
    Sitagliptin 100 mg     Placebo     Total  
Number of Participants  
[units: participants]
  96     94     190  
Age  
[units: years]
Mean ± Standard Deviation
  53.6  ± 9.5     56.1  ± 9.5     54.8  ± 9.5  
Gender  
[units: participants]
     
Female     47     55     102  
Male     49     39     88  
Race/Ethnicity, Customized  
[units: participants]
     
White     40     44     84  
Black     3     1     4  
Hispanic     31     24     55  
Asian     1     0     1  
Other     21     25     46  
2-Hour Post-Meal Glucose (2 hr PMG)  
[units: mg/dL]
Mean ± Standard Deviation
  288.7  ± 74.8     286.7  ± 61.7     287.7  ± 68.5  
Fasting Plasma Glucose (FPG)  
[units: mg/dL]
Mean ± Standard Deviation
  201.1  ± 46.2     198.2  ± 44.6     199.7  ± 45.3  
Hemoglobin A1C (A1C)  
[units: Percent]
Mean ± Standard Deviation
  9.3  ± 0.9     9.1  ± 0.8     9.2  ± 0.8  



  Outcome Measures
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1.  Primary:   Change From Baseline in A1C at Week 18   [ Time Frame: Baseline and Week 18 ]

2.  Secondary:   Change From Baseline in FPG at Week 18   [ Time Frame: Baseline and Week 18 ]

3.  Secondary:   Change From Baseline in 2 Hr-PMG at Week 18   [ Time Frame: Baseline and Week 18 ]

4.  Secondary:   Change From Baseline in A1C 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: Executive Vice President, Clinical and Quantitative Sciences
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372


Publications:

Responsible Party: Executive Vice President, Clinical and Quantitative Sciences, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT00337610     History of Changes
Other Study ID Numbers: 2006_017, MK0431-053
Study First Received: June 14, 2006
Results First Received: September 24, 2009
Last Updated: May 27, 2010
Health Authority: United States: Food and Drug Administration