Addition Of Januvia (Sitagliptin) Improves Glycemic Control In Patients Inadequately Controlled By Metformin (MK0431-078)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00545584
First received: October 16, 2007
Last updated: September 3, 2014
Last verified: September 2014
Results First Received: April 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Diabetes Mellitus, Non-Insulin-Dependent
Interventions: Drug: sitagliptin phosphate
Behavioral: Comparator: Diet
Behavioral: Comparator: Physical Activity

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1512 subjects were selected/screened, 380 subjects failed screening, leaving 1132 subjects who were randomized.

Reporting Groups
  Description
Sitagliptin With Standard of Care

Subjects received sitagliptin 100 mg once daily for 26 Weeks,

and:

No specific intervention (standard recommendation) on physical exercise and diet.

Sitagliptin With Diet Advice

Subjects received sitagliptin 100 mg once daily for 26 Weeks,

and:

Intervention on diet which includes advice on diet with a leaflet and a diary

Sitagliptin With Diet and Physical Activity Advice

Subjects received sitagliptin 100 mg once daily for 26 Weeks,

and:

Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week.


Participant Flow:   Overall Study
    Sitagliptin With Standard of Care     Sitagliptin With Diet Advice     Sitagliptin With Diet and Physical Activity Advice  
STARTED     412     414     306 [1]
COMPLETED     333     334     250  
NOT COMPLETED     79     80     56  
Only one reason for discontinuation                 62                 61                 48  
Two or more reasons for discontinuation                 17                 19                 8  
[1] 306 subjects were randomized but only 305 were treated.



  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 With Standard of Care

Subjects received sitagliptin 100 mg once daily for 26 Weeks,

and:

No specific intervention (standard recommendation) on physical exercise and diet.

Sitagliptin With Diet Advice

Subjects received sitagliptin 100 mg once daily for 26 Weeks,

and:

Intervention on diet which includes advice on diet with a leaflet and a diary

Sitagliptin With Diet and Physical Activity Advice

Subjects received sitagliptin 100 mg once daily for 26 Weeks,

and:

Intervention on diet + physical activity which includes advice on diet and physical activity with leaflets and diaries PLUS advice on physical activity with the utilization of a pedometer: subjects were asked to walk 10,000 steps per day 5 or more days per week.

Total Total of all reporting groups

Baseline Measures
    Sitagliptin With Standard of Care     Sitagliptin With Diet Advice     Sitagliptin With Diet and Physical Activity Advice     Total  
Number of Participants  
[units: participants]
  362     358     265     985  
Age [1]
[units: years]
Mean ± Standard Deviation
  58.26  ± 10.04     57.47  ± 9.12     57.30  ± 9.90     57.71  ± 9.68  
Gender [1]
[units: participants]
       
Female     181     175     126     482  
Male     181     183     139     503  
[1] The Full Analysis Set (FAS) population included all selected patients with at least one measured HbA1c value after Visit 2 and having received at least one dose of sitagliptin.



  Outcome Measures
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1.  Primary:   Hemoglobin A1c Measurement   [ Time Frame: Baseline and Week 24 ]

2.  Secondary:   Fasting Plasma Glucose (FPG) Measurement   [ Time Frame: Baseline and Week 24 ]


  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
No text entered.


  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, Late Stage Development Group Leader
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00545584     History of Changes
Other Study ID Numbers: 0431-078, 2007_023
Study First Received: October 16, 2007
Results First Received: April 19, 2011
Last Updated: September 3, 2014
Health Authority: France: Ministry of Health