Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Nesina Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus|
- Frequency of Adverse events [ 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:||August 2011|
|Estimated Study Completion Date:||January 2017|
|Estimated Primary Completion Date:||January 2017 (Final data collection date for primary outcome measure)|
Aloglipin 25 mg, tablets, orally, once daily for up to 12 months
This is a special drug use surveillance on long-term use of alogliptin, designed to investigate the safety and efficacy of treatment with alogliptin in patients with mild type 2 diabetes mellitus in the routine clinical setting.
Participants will be patients with mild type 2 diabetes mellitus. The planned sample size is 20,000.
The usual adult dosage for oral use is 1 alogliptin tablet (25 mg of alogliptin) once daily.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01964963
|Study Chair:||Postmarketing Group Manager||Takeda|