A Post Marketing Safety Study of Sitagliptin Phosphate/Metformin Hydrochloride (JANUMET®) (MK-0431A-235)

August 7, 2015 updated by: Merck Sharp & Dohme LLC

Sitagliptin Phosphate/Metformin HCl (JANUMET®) Post Marketing Surveillance Protocol

The primary objective of this study is to obtain safety information on the use of sitagliptin phosphate/metformin hydrochloride (HCl) (JANUMET®) from endocrinologists, diabetologists, internists, and general practitioners.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

143

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

  • Must be taking sitagliptin phosphate/metformin HCl (JANUMET®) for the treatment of type 2 diabetes mellitus
  • Treating physician must agree to provide information regarding the participant's treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Participants treated with sitagliptin phosphate/metformin HCl
Drug: Sitagliptin Phosphate/Metformin HCl (JANUMET®)
Participants prescribed Sitagliptin Phosphate/Metformin HCl (JANUMET®) in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of Participants With an Adverse Event
Time Frame: Up to approximately 28 months
Up to approximately 28 months
Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl
Time Frame: Up to approximately 28 months
Up to approximately 28 months
Number of Participants With Concomitant Conditions
Time Frame: Up to approximately 28 months
Up to approximately 28 months
Number of Participants Taking Concomitant Medications
Time Frame: Up to approximately 28 months
Up to approximately 28 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

May 18, 2011

First Submitted That Met QC Criteria

May 19, 2011

First Posted (Estimate)

May 20, 2011

Study Record Updates

Last Update Posted (Estimate)

August 10, 2015

Last Update Submitted That Met QC Criteria

August 7, 2015

Last Verified

August 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0431A-235

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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