MK0431 Monotherapy Study in Patients With Type 2 Diabetes Mellitus

This study has been completed.
Sponsor:
Information provided by:
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00289848
First received: February 7, 2006
Last updated: March 18, 2010
Last verified: March 2010
Results First Received: March 18, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: sitagliptin phosphate
Drug: Comparator: placebo

  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: 27-Apr-2006; Last Patient Last Visit: 30-Mar-2007; Twenty-eight medical clinics (9 in China, 9 in India, and 10 in Korea).

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Patients not on an antihyperglycemic agent (AHA) or on oral single AHA or low dose dual combination therapy could participate. After an up to 6-week diet/exercise (and wash-off period for patients on AHA), patients with hemoglobin A1C 7.5-11% and fasting plasma glucose 130-280 mg/dL entered 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.
Placebo The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.

Participant Flow:   Overall Study
    Sitagliptin 100 mg     Placebo  
STARTED     352     178  
COMPLETED     306     133  
NOT COMPLETED     46     45  
Adverse Event                 6                 4  
Death                 1                 0  
Lack of Efficacy                 20                 24  
Lost to Follow-up                 3                 1  
Protocol Violation                 5                 2  
Withdrawal by Subject                 5                 11  
Patient Moved                 6                 2  
Open-Label AHA Treatment Requested                 0                 1  



  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.
Placebo The Placebo group includes data from patients randomized to receive treatment with oral tablets of sitagliptin-matching placebo once daily.
Total Total of all reporting groups

Baseline Measures
    Sitagliptin 100 mg     Placebo     Total  
Number of Participants  
[units: participants]
  352     178     530  
Age  
[units: years]
Mean ± Standard Deviation
  50.9  ± 9.3     50.9  ± 9.3     50.9  ± 9.3  
Gender  
[units: participants]
     
Female     152     72     224  
Male     200     106     306  
Race/Ethnicity, Customized  
[units: participants]
     
Chinese     163     82     245  
Indian     127     63     190  
Korean     62     33     95  
Fasting Plasma Glucose (FPG)  
[units: mg/dL]
Mean ± Standard Deviation
  189.0  ± 44.0     190.2  ± 46.2     189.4  ± 44.7  
Hemoglobin A1C (HbA1C; A1C)  
[units: Percent]
Mean ± Standard Deviation
  8.74  ± 1.01     8.75  ± 1.06     8.74  ± 1.03  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Change From Baseline in Hemoglobin A1c (HbA1c) at Week 18   [ Time Frame: Baseline and Week 18 ]

2.  Secondary:   Change From Baseline in Fasting Plasma Glucose (FPG) at Week 18   [ Time Frame: Baseline and Week 18 ]

3.  Secondary:   Change From Baseline in 2-hr Post-Meal Glucose (PMG) at Week 18   [ Time Frame: Baseline and Week 18 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


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: NCT00289848     History of Changes
Other Study ID Numbers: 2005_094, MK0431-040
Study First Received: February 7, 2006
Results First Received: March 18, 2010
Last Updated: March 18, 2010
Health Authority: India: Ministry of Health