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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01354990
Recruitment Status : Completed
First Posted : May 17, 2011
Results First Posted : June 4, 2012
Last Update Posted : August 27, 2015
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

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

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, Learn About Clinical Studies.

Ages Eligible for Study:   Child, Adult, Older Adult
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

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

Responsible Party: Merck Sharp & Dohme Corp. 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
Hormones, Hormone Substitutes, and Hormone Antagonists
Dipeptidyl-Peptidase IV Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action