A Post-Marketing Surveillance Study on NesinaAct® Tablet Use Among Type 2 Diabetes Mellitus Participants in Korea

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

730 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-10-02

Study Completion Date

2019-08-30

Brief Summary

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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.

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Detailed Description

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The drug being tested in this survey is called NesinaAct® tablet. A surveillance is planned to examine safety and effectiveness of NesinaAct® tablet therapy in participants who are being treated for type 2 diabetes mellitus.

The study will enroll approximately 730 patients.

The study observes percentage of participants with adverse events (AEs) including serious adverse events (SAEs) and serious adverse drug reactions (SADRs) administered a dose of NesinaAct® tablet (alogliptin/pioglitazone) once daily as prescribed by the physician in routine practice over a period of 26 weeks.

This multi-center trial is conducted in a total of 19 sites in Korea.

The data is collected between October 2 2015 to August 30 2019 from the re-examination period up to 26 weeks.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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NesinaAct® Tablet

Participants with a diagnosis of Type 2 Diabetes who took NesinaAct® tablet, a fixed dose combination of alogliptin along with pioglitazone, as prescribed by the physician, are observed in this study.

NesinaAct® Tablet

Intervention Type DRUG

NesinaAct® tablet is a fixed dose combination (FDC) of alogliptin benzoate with pioglitazone HCl.

Interventions

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NesinaAct® Tablet

NesinaAct® tablet is a fixed dose combination (FDC) of alogliptin benzoate with pioglitazone HCl.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants inadequately controlled on diet and exercise.
* Participants inadequately controlled on metformin alone.
* Participants inadequately controlled on pioglitazone alone.
* Participants inadequately controlled on metformin and pioglitazone combination therapy.
* Participants switching from alogliptin co-administered with pioglitazone.

Exclusion Criteria

* Participants treated with study drug outside of the locally approved label in Korea.
* Participants with contraindication for the use of study drug (as described in the Korean product label).

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No