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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by:

Merck

ClinicalTrials.gov Identifier:

NCT01357135

First received: May 18, 2011

Last updated: March 14, 2012

Last verified: March 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	May 18, 2011
Last Updated Date	March 14, 2012
Start Date ^ICMJE	July 2009
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: May 19, 2011)	Treatment Maintenance Duration [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01357135 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	An Observational Study of Type II Diabetics Treated With Bitherapy With or Without Januvia®/Xelevia® (MK-0431-201)
Official Title ^ICMJE	Observational Study of the Treatment and Follow-up of Patients With Type II Diabetes Receiving Bitherapy With or Without Januvia®/Xelevia®.
Brief Summary	This is a study to compare the effectiveness of the treatment of Type II diabetics with metformin + Januvia®/Xelevia® versus metformin + sulfonylurea.
Detailed Description	Not Provided
Study Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Case Control Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
Sampling Method	Non-Probability Sample
Study Population	Patients with type II diabetes receiving a de novo prescription (for the first time or within less than 8 weeks) for bitherapy with or without Januvia®/Xelevia® or any other treatment regimen including Januvia®/Xelevia® by general practitioners in private practice under real life conditions without any additional treatment or monitoring procedures.
Condition ^ICMJE	Diabetes Mellitus, Type 2
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	metformin + sulfonylurea metformin + Januvia®/Xelevia Januvia®/Xelevia®
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	3360
Estimated Completion Date	December 2013
Estimated Primary Completion Date	December 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Not previously treated for Type 2 diabetes mellitus (or have started therapy with the drugs for <8 weeks) Must be equally eligible for the use of Januvia®/Xelevia® or a sulfonylurea for the treatment of Type 2 diabetes mellitus
Gender	Both
Ages	Not Provided
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01357135
Other Study ID Numbers ^ICMJE	MK-0431-201
Has Data Monitoring Committee	No
Responsible Party	Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
Study Sponsor ^ICMJE	Merck
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Merck
Verification Date	March 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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