N/A
Completed N=3,623
A Study for Post-Marketing Surveillance of Nesina® Tablet Monotherapy or Combination Therapy in Participants With Type 2 Diabetes (T2DM) in South Korea
Source: ClinicalTrials.gov NCT04980040 ↗Enrolled (actual)
3,623
Serious AEs
1.2%
Results posted
Apr 2022
Primary outcomePrimary: Percentage of Participants With Serious Adverse Events (SAEs) — 1.18 percentage of participants
Summary
The purpose of this study is to evaluate safety by determining the incidence rates of all adverse events (AEs) including serious adverse events (SAEs)/serious adverse drug reactions (ADRs), unexpected AEs and ADRs that are not reflected in the precautions for use, ADRs already known, non-serious ADRs and other safety related information among participants who have received alogliptin for type 2 diabetes mellitus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Serious Adverse Events (SAEs) |
1.18 | — |
| PRIMARY Percentage of Participants With Serious Adverse Drug Reactions (ADRs) |
0.16 | — |
| PRIMARY Percentage of Participants With Unexpected Adverse Events |
8.88 | — |
| PRIMARY Percentage of Participants With Unexpected Adverse Drug Reactions (ADRs) |
2.01 | — |
| SECONDARY Haemoglobin (HbA1c) Levels |
8.05; 6.96; 6.87 | — |
| SECONDARY Fasting Blood Glucose Levels |
166.22; 136.84; 133.09 | — |
| SECONDARY Percentage of Participants With HbA1c < 7.00% |
17.84; 60.96; 63.49 | — |
| SECONDARY Percentage of Participants With Overall Improvement and Final Effectiveness Assessment |
82.57; 9.64; 7.79 | — |
Eligibility Criteria
Inclusion Criteria
- Had one of the following treatments with alogliptin for the first time as an adjunct to diet and exercise to improve glycemic control:
- Monotherapy with alogliptin
- Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with metformin or sulfonylurea or thiazolidinedione single therapy
- Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with thiazolidinedione and metformin combination therapy
- Combination therapy with the surveillance drug (alogliptin) in case of inadequate glycemic control with insulin (single therapy or combination with metformin) therapy
- Combination therapy with metformin in patients who have no prior history of antidiabetic medication and may not achieve adequate glycemic control with monotherapy alogliptin
Exclusion Criteria
- Had alogliptin treatment outside of the locally approved label in Korea
- Had a contraindication for the use of alogliptin (as described in the Korean product label)
Data sourced from ClinicalTrials.gov (NCT04980040). 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. Informational only — not medical advice.