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A Post Marketing Safety Study of Sitagliptin (JANUVIA®) (MK-0431-234)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck
ClinicalTrials.gov Identifier:
NCT01354990
First received: May 16, 2011
Last updated: May 1, 2012
Last verified: May 2012
History of Changes
  Purpose

The primary objective of this study is to obtain safety information on the use of sitagliptin (JANUVIA®) from endocrinologists, diabetologists, internists, and general practitioners.


Condition Intervention
Diabetes Mellitus, Type 2
 Drug: Sitagliptin (JANUVIA®)

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sitagliptin (JANUVIA®) Post Marketing Surveillance Protocol

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:
  • Number of Participants With an Adverse Event [ Time Frame: Up to approximately 28 months ] [ Designated as safety issue: Yes ]
  • Age of Participants Prescribed Sitagliptin [ Time Frame: Up to approximately 28 months ] [ Designated as safety issue: No ]
  • Number of Participants With Concomitant Therapies [ Time Frame: Up to approximately 28 months ] [ Designated as safety issue: No ]
  • Number of Participants With Concomitant Conditions [ Time Frame: Up to approximately 28 months ] [ Designated as safety issue: No ]

Enrollment: 2974
Study Start Date: February 2009
Study Completion Date: May 2010
Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Participants treated with sitagliptin Drug: Sitagliptin (JANUVIA®)
Participants prescribed Sitagliptin (JANUVIA®) in routine clinical practice.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Participants with type 2 diabetes mellitus who are treated with sitagliptin as per the standard of care in a physician's practice

Criteria

Inclusion Criteria:

  • Must be taking sitagliptin (JANUVIA™) for the treatment of type 2 diabetes mellitus
  • Treating physician must agree to provide information regarding the participants treatment
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Merck
ClinicalTrials.gov Identifier: NCT01354990     History of Changes
Other Study ID Numbers: MK-0431-234
Study First Received: May 16, 2011
Results First Received: February 1, 2012
Last Updated: May 1, 2012
Health Authority: Philippines: Bureau of Food and Drugs

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 18, 2013