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A Study of Sitagliptin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Diet/Exercise Therapy (0431-054)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00411554
First received: December 13, 2006
Last updated: November 7, 2014
Last verified: November 2014
Results First Received: August 19, 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: Diabetes Mellitus, Non-Insulin-Dependent
Interventions: Drug: sitagliptin phosphate
Drug: Comparator: voglibose

  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: 6 January 2007. Last patient, last visit: 15 August 2007. The study was conducted at 71 centers in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients at least 20 years of age with type 2 diabetes mellitus and inadequate glycemic control (HbA1c ≥6.5% and <10% at Week -2) were eligible for randomization following at least 8 weeks of diet/exercise and antihyperglycemic agent (AHA) wash-off (for patients previously on an AHA), including a 2-week placebo run-in.

Reporting Groups
  Description
Sitagliptin 50 mg QD The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
Voglibose 0.2 mg TID The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).

Participant Flow:   Overall Study
    Sitagliptin 50 mg QD     Voglibose 0.2 mg TID  
STARTED     163 [1]   156 [1]
COMPLETED     155     147  
NOT COMPLETED     8     9  
Adverse Event                 2                 4  
Lack of Efficacy                 2                 5  
Withdrawal by Subject                 3                 0  
Patient Moved                 1                 0  
[1] Study enrolled slightly more than the target of N=155



  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 50 mg QD The Sitagliptin group includes data from all patients randomized to receive treatment with sitagliptin 50 mg orally once daily (QD=once daily).
Voglibose 0.2 mg TID The Voglibose group includes data from all patients randomized to receive treatment with voglibose 0.2 mg orally three times daily (TID= three times daily).
Total Total of all reporting groups

Baseline Measures
    Sitagliptin 50 mg QD     Voglibose 0.2 mg TID     Total  
Number of Participants  
[units: participants]
  163     156     319  
Age  
[units: years]
Mean ± Standard Deviation
  60.8  ± 10.1     60.6  ± 10.0     60.7  ± 10.0  
Gender  
[units: participants]
     
Female     45     62     107  
Male     118     94     212  
Fasting Plasma Glucose (FPG)  
[units: mg/dL]
Mean ± Standard Deviation
  148.7  ± 34.2     148.9  ± 31.0     148.8  ± 32.6  
Hemoglobin A1c (HbA1c)  
[units: percent]
Mean ± Standard Deviation
  7.8  ± 0.9     7.8  ± 0.9     7.8  ± 0.9  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in HbA1c at Week 12   [ Time Frame: Baseline and Week 12 ]

2.  Secondary:   Change From Baseline in Fasting Plasma Glucose at Week 12   [ Time Frame: Baseline and Week 12 ]

3.  Secondary:   Change From Baseline in 2 Hour Postprandial Glucose at Week 12   [ Time Frame: Baseline and Week 12 ]


  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 of Results:

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00411554     History of Changes
Other Study ID Numbers: 0431-054, 2006_051
Study First Received: December 13, 2006
Results First Received: August 19, 2009
Last Updated: November 7, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency