Januvia Re-examination Study (MK-0431-181)
Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of Januvia in Usual Practice
2 other identifiers
observational
3,483
0 countries
N/A
Brief Summary
The objectives of this survey are: 1) To examine the safety/efficacy profile of Januvia in Korean participants, and 2) To identify factors that might have an influence on the safety and efficacy profile of Januvia in Korean participants. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2008
Longer than P75 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2008
CompletedFirst Submitted
Initial submission to the registry
February 2, 2010
CompletedFirst Posted
Study publicly available on registry
February 4, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedFebruary 5, 2016
February 1, 2016
4.8 years
February 2, 2010
February 3, 2016
Conditions
Outcome Measures
Primary Outcomes (4)
Percentage of participants with any adverse experience
up to 14 days following cessation of treatment
Mean change in Hemoglobin A1c (HbA1c)
12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
Mean change in fasting plasma glucose (FPG)
12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
Mean change in 2hr-postprandial glucose (PPG)
12 weeks ± 2 weeks and 24 weeks ± 2 weeks after first treatment
Study Arms (1)
All participants
Participants administered Januvia up to 100 mg once daily as monotherapy or combination therapy with a sulfonylurea or with insulin during the re-examination period (up to 6 years)
Interventions
Sitagliptin phosphate monohydrate 25 mg, 50 mg, or 100 mg tablet administered in general use according to the local label
Sulfonylurea administered in general use according to the local label
Eligibility Criteria
Korean participants with Type 2 Diabetes Mellitus being treated with Januvia
You may qualify if:
- Type 2 Diabetes Mellitus
- Treated With Januvia within local label for the first time
You may not qualify if:
- Contraindication to Januvia according to the local label
- Treated with Januvia before contract and out of enrollment period
- Treated with Januvia for more than or equal to 24 weeks
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Merck Sharp & Dohme LLC
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 2, 2010
First Posted
February 4, 2010
Study Start
October 1, 2008
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
February 5, 2016
Record last verified: 2016-02