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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00545584
First Posted: October 17, 2007
Last Update Posted: October 12, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
Results First Submitted: April 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (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 
Overall Participants Analyzed 
[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) 
[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.
Sex: Female, Male [1] 
[Units: Participants]
Count of Participants
       
Female      181  50.0%      175  48.9%      126  47.5%      482  48.9% 
Male      181  50.0%      183  51.1%      139  52.5%      503  51.1% 
[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
  Show All Outcome Measures

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
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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: Senior Vice President, Global Clinical Development
Organization: Merck Sharp & Dohme Corp
phone: 1-800-672-6372
e-mail: ClinicalTrialsDisclosure@merck.com



Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00545584     History of Changes
Other Study ID Numbers: 0431-078
2007_023
First Submitted: October 16, 2007
First Posted: October 17, 2007
Results First Submitted: April 19, 2011
Results First Posted: May 11, 2011
Last Update Posted: October 12, 2017