N/A
Completed N=19,192
Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus
Source: ClinicalTrials.gov NCT01964963 ↗Enrolled (actual)
19,192
Serious AEs
0.4%
Results posted
May 2019
Primary outcomePrimary: Percentage of Participants Who Had One or More Adverse Events — 10.54 Percentage of Participants
Summary
The purpose of this study is to examine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with mild type 2 diabetes mellitus in the routine clinical setting.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Who Had One or More Adverse Events |
10.54 | — |
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
-0.14 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose |
-5.8 | — |
Eligibility Criteria
Inclusion Criteria
-Patients with Haemoglobin A1c (HbA1c) [Japan Diabetes Society (JDS) value] ≤7.0% at the time of enrolment (within 3 months before initiation of alogliptin therapy), regardless of the use of antidiabetic medication.
Exclusion Criteria
-Patients contraindicated for alogliptin.
- Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus.
- Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury.
- Patients with a history of hypersensitivity to any ingredient of alogliptin.
Data sourced from ClinicalTrials.gov (NCT01964963). 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.