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

This study has been completed.
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
First received: May 16, 2011
Last updated: August 26, 2015
Last verified: August 2015
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:

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

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.


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

Inclusion Criteria:

- Must be taking sitagliptin (JANUVIA™) for the treatment of type 2 diabetes


- Treating physician must agree to provide information regarding the participants treatment

  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

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01354990     History of Changes
Other Study ID Numbers: 0431-234 
Study First Received: May 16, 2011
Results First Received: February 1, 2012
Last Updated: August 26, 2015
Health Authority: Philippines: Bureau of Food and Drugs

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

ClinicalTrials.gov processed this record on May 26, 2016