Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 3,317
- Primary Endpoint
- Number of Participants Who Experience at Least One Adverse Events
Study Overview
Brief 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.
Detailed Description
A special drug use surveillance is planned to examine the safety and efficacy of long-term use of alogliptin in patients with type 2 diabetes mellitus under the daily clinical use conditions.
Participants of this surveillance will be patients with type 2 diabetes mellitus who failed to respond adequately to diet therapy and exercise therapy alone or to a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor. The planned sample size is 3,000 subjects.
The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily. Participants will receive the drug as part of routine medical care.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Alogliptin 25mg, tablets, orally, once daily, up to 36 months
Intervention: Alogliptin (Drug)
Outcomes
Primary Outcomes
Number of Participants Who Experience at Least One Adverse Events
Time Frame: Up to Month 36
Change From Baseline in Glycosylated Hemoglobin (HbA1c)
Time Frame: Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36)
The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at month 36 relative to baseline.
Secondary Outcomes
- Change From Baseline in Fasting Blood Glucose(Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36))