Study Stopped
Completion of MK-0431A-235 was rendered unnecessary, as the local oversight authority accepted in its stead the results of another study \[MK-0431-234\].
A Post Marketing Safety Study of Sitagliptin Phosphate/Metformin Hydrochloride (JANUMET®) (MK-0431A-235)
Sitagliptin Phosphate/Metformin HCl (JANUMET®) Post Marketing Surveillance Protocol
1 other identifier
observational
143
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Mar 2009
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedFirst Submitted
Initial submission to the registry
May 18, 2011
CompletedFirst Posted
Study publicly available on registry
May 20, 2011
CompletedResults Posted
Study results publicly available
March 7, 2012
CompletedAugust 10, 2015
August 1, 2015
1.2 years
May 18, 2011
February 1, 2012
August 7, 2015
Conditions
Outcome Measures
Primary Outcomes (4)
Number of Participants With an Adverse Event
Up to approximately 28 months
Age of Participants Prescribed Sitagliptin Phosphate/Metformin HCl
Up to approximately 28 months
Number of Participants With Concomitant Conditions
Up to approximately 28 months
Number of Participants Taking Concomitant Medications
Up to approximately 28 months
Study Arms (1)
Participants treated with sitagliptin phosphate/metformin HCl
Interventions
Participants prescribed Sitagliptin Phosphate/Metformin HCl (JANUMET®) in routine clinical practice.
Eligibility Criteria
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
You may qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Senior Vice President, Global Clinical Development
- Organization
- Merck Sharp & Dohme Corp
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 18, 2011
First Posted
May 20, 2011
Study Start
March 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
August 10, 2015
Results First Posted
March 7, 2012
Record last verified: 2015-08