An Observational Study of Type II Diabetics Treated With Bitherapy With or Without 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: January 22, 2014
Last verified: January 2014

May 18, 2011
January 22, 2014
July 2009
August 2013   (final data collection date for primary outcome measure)
Treatment Maintenance Duration [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01357135 on ClinicalTrials.gov Archive Site
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An Observational Study of Type II Diabetics Treated With Bitherapy With or Without Januvia®/Xelevia® (MK-0431-201)
Observational Study of the Treatment and Follow-up of Patients With Type II Diabetes Receiving Bitherapy With or Without Januvia®/Xelevia®.

This is a study to compare the effectiveness of the treatment of Type II diabetics with metformin + Januvia®/Xelevia® versus metformin + sulfonylurea.

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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Non-Probability Sample

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.

Diabetes Mellitus, Type 2
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  • metformin + sulfonylurea
  • metformin + Januvia®/Xelevia
  • Januvia®/Xelevia®
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
4031
August 2013
August 2013   (final data collection date for primary outcome measure)

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
Both
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No
Contact information is only displayed when the study is recruiting subjects
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NCT01357135
0431-201
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP