Clinical trial NCT04980014: A Post-Marketing Surveillance Study on NesinaAct® Tablet Use Among Type 2 Diabetes Mellitus Participants in Korea
Official title: Post-Marketing Surveillance Study on NesinaAct Tablet® Use Among Type 2 Diabetes Mellitus Patients in Korea
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Type 2 Diabetes Mellitus
Keywords: Drug Therapy
Lead sponsor: Takeda
Sponsor class: INDUSTRY
First posted: 2021-07-28
Enrollment: 730
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult participants diagnosed with type 2 diabetes mellitus (T2DM) will be observed.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Percentage of Participants With Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs)
timeFrame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
measure: Percentage of Participants With Unexpected Adverse Events (AEs) and Adverse Drug Reactions (ADRs) Not Mentioned in Precautions
timeFrame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
measure: Percentage of Participants With Expected/Already Known ADRs at Week 13
timeFrame: Week 13
measure: Percentage of Participants With Expected/Already Known ADRs at Week 26
timeFrame: Week 26
measure: Percentage of Participants With Expected/Already Known ADRs at Week 39
timeFrame: Week 39
measure: Percentage of Participants With Expected/Already Known ADRs at Week 52
timeFrame: Week 52
measure: Percentage of Participants With Expected/Already Known ADRs at Week 153
timeFrame: Week 153
measure: Percentage of Participants With Non-serious ADRs
timeFrame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
measure: Percentage of Participants With Abnormal Laboratory Findings Reported as AEs
timeFrame: First dose of surveillance drug treatment to within 30 days after the end of the treatment (up to 153 weeks)
Secondary outcomes:
measure: Change From Baseline in Haemoglobin A1c (HbA1c) Levels
timeFrame: Baseline, Weeks 13 and 26
measure: Change From Baseline in Fasting Serum Glucose
timeFrame: Baseline, Weeks 13 and 26
measure: Change From Baseline in Total Cholesterol
timeFrame: Baseline, Weeks 13 and 26
measure: Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C)
timeFrame: Baseline, Weeks 13 and 26
measure: Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C)
timeFrame: Baseline, Weeks 13 and 26
measure: Change From Baseline in Body Weight
timeFrame: Baseline, Weeks 13 and 26
measure: Change From Baseline in Systolic Blood Pressure
timeFrame: Baseline, Weeks 13 and 26
measure: Change From Baseline in Diastolic Blood Pressure
timeFrame: Baseline, Weeks 13 and 26
Other outcomes:
Locations:
city: Busan
country: Korea, Republic of
city: Chuncheon
country: Korea, Republic of
city: Daejeon
country: Korea, Republic of
city: Gangneung-si
country: Korea, Republic of
city: Goyang-si
country: Korea, Republic of
city: Jeonju
country: Korea, Republic of
city: Seongam
country: Korea, Republic of
city: Seoul
country: Korea, Republic of
Study officials:
affiliation: Takeda
name: Study Director
role: STUDY_DIRECTOR
References: