At a glance
ClinicalIndex Comparison RecordN/ACompleted· 4,065 enrolled
Drug / intervention
Sitagliptin/metformindrug
Likely dose
Sitagliptin/metformin 500 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Re-examination Study for General Drug Use to Assess the Safety and Efficacy Profile of JANUMET in Usual Practice
In Brief
An observational study evaluating Sitagliptin/metformin for Type 2 Diabetes Mellitus. Completed, enrolled 4,065 participants.
Detailed Summary
This survey is conducted for preparing application materials for re-examination under the Pharmaceutical Affairs Laws and its Enforcement Regulation, its aim is to reconfirm the clinical usefulness of sitagliptin/metformin (JANUMET) through collecting the safety and efficacy information according to the Re-examination Regulation for New Drugs.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
Countries--
Collaborators--
Timeline
N/ACompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartMar 2009
First PostedFeb 2010
Primary CompletionMay 2013
TodayJul 2026
First PostedFeb 9, 2010
Enrollment StartMar 1, 2009
Primary CompletionMay 1, 2013
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 16.4 years ago
Interventions
Sitagliptin/metformindrug
Sitagliptin/metformin 50/500 mg, 50/850 mg, or 50/1000 mg tablet administered twice daily with meals.