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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
  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:

U.S. FDA Resources

Further study details as provided by Merck:

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

Estimated Enrollment: 3360
Study Start Date: July 2009
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Vice President, Late Stage Development Group Leader, Merck Sharp & Dohme Corp
ClinicalTrials.gov Identifier: NCT01357135     History of Changes
Other Study ID Numbers: MK-0431-201
Study First Received: May 18, 2011
Last Updated: March 14, 2012
Health Authority: France: Haute Autorité de Santé Transparency Commission

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Sitagliptin
Dipeptidyl-Peptidase IV Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Hypoglycemic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on June 17, 2013