Alogliptin/Pioglitazone (Liovel) Liovel Combination Tablets Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Long-term Use of Alogliptin/Pioglitazone Combination Tablets in Patients With Type 2 Diabetes Mellitus|
- Frequency of Adverse events [ Time Frame: 12 months ]The frequency of adverse events by type, seriousness, type 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 Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline and month 12 ]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 12 relative to baseline.
- Change from Baselin in Fasting blood glucose [ Time Frame: Baseline and 12 months ]The change in the value of fasting blood glucose collected at month 12 relative to baseline.
|Study Start Date:||November 2011|
|Study Completion Date:||March 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Alogliptin/pioglitazone (Liovel) combination tablets
Alogliptin/pioglitazone (Liovel) combination tablets, taken orally, once daily for up to 12 months
Alogliptin/pioglitazone combination tablets
Other Name: Liovel、SYR-322-4833
This is a special drug use surveillance on long-term use of alogliptin/pioglitazone combination tablets. This study is designed to investigate the safety and efficacy of long-term use of alogliptin/pioglitazone combination tablet in patients with type 2 diabetes mellitus in the routine clinical setting.
Participants will be patients with type 2 diabetes mellitus. The planned sample size is 3000.
The usual adult dosage is 1 tablet (containing alogliptin/pioglitazone at either 25 mg/15 mg or 25 mg/30 mg) taken orally once daily before or after breakfast.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01990300
|Study Chair:||Postmarketing Group Manager||Takeda|