An Observational Study of Type II Diabetics Treated With Dual Therapy With or Without Sitagliptin (Januvia®/Xelevia®, MK-0431-201)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01357135
First received: May 18, 2011
Last updated: December 4, 2014
Last verified: December 2014
Results First Received: November 14, 2014  
Study Type: Observational
Study Design: Time Perspective: Prospective
Condition: Type 2 Diabetes Mellitus
Interventions: Drug: Metformin
Drug: Sitagliptin
Drug: Sulfonylurea
Drug: Antihyperglycemic Medication

  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
This was an observational, non-randomized, prospective, longitudinal study of participants with Type 2 diabetes mellitus treated in routine clinical practice by 1,569 primary care practitioners in metropolitan France. Study participants were enrolled from July 29, 2009 to December 31, 2010. The end of study follow-up was August 31, 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Metformin + Sitagliptin Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
Metformin + Sulfonylurea Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
Sitagliptin +/- Other Antihyperglycemic Medication Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.

Participant Flow:   Overall Study
    Metformin + Sitagliptin     Metformin + Sulfonylurea     Sitagliptin +/- Other Antihyperglycemic Medication  
STARTED     1874     733     846  
COMPLETED     1276     510     583  
NOT COMPLETED     598     223     263  



  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.
Baseline gender data is missing for 8 participants in the Metformin + Sitagliptin group.

Reporting Groups
  Description
Metformin + Sitagliptin Participants taking metformin + sitagliptin (Januvia®/Xelevia®) as prescribed in routine clinical practice.
Metformin + Sulfonylurea Participants taking metformin + sulfonylurea as prescribed in routine clinical practice. The sulfonylurea could include: gliclazide, glibenclamide, or glimepiride.
Sitagliptin +/- Other Antihyperglycemic Medication Participants taking sitagliptin +/- other antihyperglycemic medications (other than metformin) as prescribed in routine clinical practice. These other antihyperglycemic medications could include: insulin, glinides, sulfonylurea, glitazone, an alpha-glucosidase inhibitor, or combinations thereof.
Total Total of all reporting groups

Baseline Measures
    Metformin + Sitagliptin     Metformin + Sulfonylurea     Sitagliptin +/- Other Antihyperglycemic Medication     Total  
Number of Participants  
[units: participants]
  1874     733     846     3453  
Age  
[units: Years]
Mean (Standard Deviation)
  62.4  (10.8)     64.2  (11.5)     65.5  (11.3)     63.5  (11.2)  
Gender, Customized  
[units: Participants]
       
Female     758     311     372     1441  
Male     1108     422     474     2004  
Missing     8     0     0     8  



  Outcome Measures
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1.  Primary:   Median Duration (in Months) of Initial Dual Therapy   [ Time Frame: Up to 3 years ]

2.  Primary:   Percentage of Participants With Strict Changes in Initial Dual Therapy   [ Time Frame: Up to 3 years ]


  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
The adverse events in this study were not systematically collected or assessed and therefore no direct comparison can be made between adverse events in the 3 study groups/arms.


  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


No publications provided


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01357135     History of Changes
Other Study ID Numbers: 0431-201
Study First Received: May 18, 2011
Results First Received: November 14, 2014
Last Updated: December 4, 2014
Health Authority: France: Haute Autorité de Santé Transparency Commission