N/A
N=730
A Post-Marketing Surveillance Study on NesinaAct® Tablet Use Among Type 2 Diabetes Mellitus Participants in Korea
Type 2 Diabetes Mellitus
Bottom Line
View on ClinicalTrials.gov: NCT04980014 ↗Enrolled (actual)
730
Serious AEs
0.2%
Results posted
Mar 2022
Primary outcome: Primary: Percentage of Participants With Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) — 0.15; 0.00 percentage of participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- NesinaAct® Tablet (Drug)
- Age
- Adult, Older Adult · 19+ yrs
- Sex
- All
- Sponsor
- Takeda
- Primary completion
- Aug 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) and Serious Adverse Drug Reactions (SADRs) |
0.15; 0.00 | — |
| PRIMARY Percentage of Participants With Unexpected Adverse Events (AEs) and Adverse Drug Reactions (ADRs) Not Mentioned in Precautions |
4.58; 1.22 | — |
| PRIMARY Percentage of Participants With Expected/Already Known ADRs at Week 13 |
1.99 | — |
| PRIMARY Percentage of Participants With Expected/Already Known ADRs at Week 26 |
0.19 | — |
| PRIMARY Percentage of Participants With Expected/Already Known ADRs at Week 39 |
0.00 | — |
| PRIMARY Percentage of Participants With Expected/Already Known ADRs at Week 52 |
0.93 | — |
| PRIMARY Percentage of Participants With Expected/Already Known ADRs at Week 153 |
0.00 | — |
| PRIMARY Percentage of Participants With Non-serious ADRs |
3.36 | — |
| PRIMARY Percentage of Participants With Abnormal Laboratory Findings Reported as AEs |
0.46; 0.31; 0.15; 0.15; 0.15; 0.15 | — |
| SECONDARY Change From Baseline in Haemoglobin A1c (HbA1c) Levels |
7.90; -0.93; -1.40 | — |
| SECONDARY Change From Baseline in Fasting Serum Glucose |
170.75; -25.26; -33.49 | — |
| SECONDARY Change From Baseline in Total Cholesterol |
182.51; -13.14; -8.64 | — |
| SECONDARY Change From Baseline in Low Density Lipoprotein-Cholesterol (LDL-C) |
104.65; -7.85; -8.28 | — |
| SECONDARY Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C) |
47.18; 2.36; 1.90 | — |
| SECONDARY Change From Baseline in Body Weight |
69.98; -0.67; -0.48 | — |
| SECONDARY Change From Baseline in Systolic Blood Pressure |
128.20; -0.88; -1.66 | — |
| SECONDARY Change From Baseline in Diastolic Blood Pressure |
79.84; -1.40; -0.34 | — |
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.
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).
Data sourced from ClinicalTrials.gov (NCT04980014). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.