N/A
Completed N=3,317
Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"
Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution
Source: ClinicalTrials.gov NCT01945216 ↗
Enrolled (actual)
3,317
Serious AEs
0.4%
Results posted
Nov 2018
Primary outcomePrimary: Number of Participants Who Experience at Least One Adverse Events — 151; 98; 139 Participants
Summary
The purpose of this study is to determine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor.
In addition, examining the safety and efficacy of alogliptin in patients with renal impairment, information on the appropriate dosage of alogliptin according to the severity of impaired renal function should be collected.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Experience at Least One Adverse Events |
151; 98; 139 | — |
| PRIMARY Change From Baseline in Glycosylated Hemoglobin (HbA1c) |
-0.45; -0.33; -0.79; -0.54; -0.84; -0.70 | — |
| SECONDARY Change From Baseline in Fasting Blood Glucose |
-22.9; -4.9; -21.7; -8.3; -19.1; -14.5 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with type 2 diabetes mellitus who have not adequately responded to any one of the following therapies:
- Diet therapy and exercise therapy alone
- In addition to diet therapy and exercise therapy, use of α-glucosidase inhibitor
Exclusion Criteria
- Patients contraindicated for Nesina
- Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.)
- Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury (blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.)
- Patients with a history of hypersensitivity to any ingredient of Nesina
Data sourced from ClinicalTrials.gov (NCT01945216). 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.