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
  Purpose

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


Condition
Diabetes Mellitus, Type 2

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Observational Study of the Treatment and Follow-up of Patients With Type II Diabetes Receiving Bitherapy With or Without Januvia®/Xelevia®.

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • Treatment Maintenance Duration [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]

Enrollment: 4031
Study Start Date: July 2009
Study Completion Date: August 2013
Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
metformin + sulfonylurea
metformin + Januvia®/Xelevia
Januvia®/Xelevia®

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

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
Last Updated: January 22, 2014
Health Authority: France: Haute Autorité de Santé Transparency Commission

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on October 29, 2014