Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"
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.
Patients With Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Nesina Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"|
- Frequency of Adverse event [ Time Frame: 36 months ] [ Designated as safety issue: Yes ]The frequency of adverse events by type, seriousness, time to onset, etc. Adverse events are defined as any unfavorable and unintended sign, symptom or disease temporally associated with the use of a medicinal product reported from first dose of study drug to the last dose of study drug.
- Change from Baselin in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline and month 36 ] [ Designated as safety issue: No ]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.
- Change from Baselin in Fasting Blood Glucose [ Time Frame: Baseline and month 36 ] [ Designated as safety issue: No ]The change in the value of fasting blood glucose collected at month 36 relative to baseline.
|Study Start Date:||July 2010|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
|Aloglipin 25mg, tablets, orally, once daily, up to 36 months||
Other Name: Nesina; SYR-322
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01945216
|Study Chair:||Postmarketing Group Manager||Takeda|