NCT01354990

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,974

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2009

Status
completed

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

February 1, 2009

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

May 16, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 17, 2011

Completed
1.1 years until next milestone

Results Posted

Study results publicly available

June 4, 2012

Completed
Last Updated

August 27, 2015

Status Verified

August 1, 2015

Enrollment Period

1.2 years

First QC Date

May 16, 2011

Results QC Date

February 1, 2012

Last Update Submit

August 26, 2015

Conditions

Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (4)

  • Number of Participants With an Adverse Event

    Up to approximately 28 months

  • Age of Participants Prescribed Sitagliptin

    Up to approximately 28 months

  • Number of Participants With Concomitant Therapies

    Up to approximately 28 months

  • Number of Participants With Concomitant Conditions

    Up to approximately 28 months

Study Arms (1)

Participants treated with sitagliptin

Drug: Sitagliptin (JANUVIA®)

Interventions

Sitagliptin (JANUVIA®)DRUG

Participants prescribed Sitagliptin (JANUVIA®) in routine clinical practice.

Participants treated with sitagliptin

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • \- Must be taking sitagliptin (JANUVIA™) for the treatment of type 2 diabetes
  • mellitus
  • \- Treating physician must agree to provide information regarding the participants treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Sitagliptin Phosphate

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

TriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrazines

Results Point of Contact

Title
Senior Vice President, Global Clinical Development
Organization
Merck Sharp & Dohme Corp
ClinicalTrialsDisclosure@merck.com
1-800-672-6372

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 16, 2011

First Posted

May 17, 2011

Study Start

February 1, 2009

Primary Completion

May 1, 2010

Study Completion

May 1, 2010

Last Updated

August 27, 2015

Results First Posted

June 4, 2012

Record last verified: 2015-08