Alogliptin/Pioglitazone (Liovel) Liovel Combination Tablets Survey on Long-term Use in Patients With Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT01990300|
Recruitment Status : Completed
First Posted : November 21, 2013
Last Update Posted : July 25, 2017
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes Mellitus||Drug: Alogliptin/pioglitazone|
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.
|Study Type :||Observational|
|Actual Enrollment :||3281 participants|
|Official Title:||Long-term Use of Alogliptin/Pioglitazone Combination Tablets in Patients With Type 2 Diabetes Mellitus|
|Actual Study Start Date :||November 28, 2011|
|Actual Primary Completion Date :||March 31, 2015|
|Actual Study Completion Date :||March 31, 2015|
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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01990300
|Study Director:||Study Director||Takeda|