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

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ClinicalTrials.gov Identifier: NCT01354990
Recruitment Status : Completed
First Posted : May 17, 2011
Results First Posted : June 4, 2012
Last Update Posted : August 27, 2015
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.

Brief Summary:
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 or disease Intervention/treatment
Diabetes Mellitus, Type 2 Drug: Sitagliptin (JANUVIA®)

Study Type : Observational
Actual Enrollment : 2974 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Sitagliptin (JANUVIA®) Post Marketing Surveillance Protocol
Study Start Date : February 2009
Actual Primary Completion Date : May 2010
Actual Study Completion Date : May 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Group/Cohort Intervention/treatment
Participants treated with sitagliptin Drug: Sitagliptin (JANUVIA®)
Participants prescribed Sitagliptin (JANUVIA®) in routine clinical practice.



Primary Outcome Measures :
  1. Number of Participants With an Adverse Event [ Time Frame: Up to approximately 28 months ]
  2. Age of Participants Prescribed Sitagliptin [ Time Frame: Up to approximately 28 months ]
  3. Number of Participants With Concomitant Therapies [ Time Frame: Up to approximately 28 months ]
  4. Number of Participants With Concomitant Conditions [ Time Frame: Up to approximately 28 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
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


Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT01354990     History of Changes
Other Study ID Numbers: 0431-234
First Posted: May 17, 2011    Key Record Dates
Results First Posted: June 4, 2012
Last Update Posted: August 27, 2015
Last Verified: August 2015

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