At a glance
ClinicalIndex Comparison RecordN/ACompleted· 730 enrolled
Drug / intervention
NesinaAct® Tabletdrug
Likely dose
Not stated in 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.
Post-Marketing Surveillance Study on NesinaAct Tablet® Use Among Type 2 Diabetes Mellitus Patients in Korea
In Brief
An observational study evaluating NesinaAct® Tablet for Type 2 Diabetes Mellitus. Completed, enrolled 730 participants across 8 sites.
Detailed Summary
The purpose of this post marketing surveillance (PMS) study is to estimate the proportion of all adverse events (AEs) including serious adverse events (SAEs) and serious adverse drug reactions (SADRs) in participants who are treated for type 2 diabetes mellitus under NesinaAct® tablet therapy (alogliptin/pioglitazone) once daily by physicians in the real-world clinical practice setting over a period of 26 weeks.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsType 2 Diabetes Mellitus
CountriesSouth Korea
Collaborators--
Timeline
N/ACompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartOct 2015
Primary CompletionAug 2019
First PostedJul 2021
TodayJul 2026
First PostedJul 28, 2021
Enrollment StartOct 2, 2015
Primary CompletionAug 30, 2019
TodayJul 2, 2026
Enrollment to primary: 3.9 yearsPosted 4.9 years ago
Interventions
NesinaAct® Tabletdrug
NesinaAct® tablet is a fixed dose combination (FDC) of alogliptin benzoate with pioglitazone HCl.