Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus
|ClinicalTrials.gov Identifier: NCT01964963|
Recruitment Status : Completed
First Posted : October 17, 2013
Last Update Posted : August 1, 2017
|Condition or disease||Intervention/treatment|
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.
|Study Type :||Observational|
|Actual Enrollment :||19192 participants|
|Official Title:||Nesina Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus|
|Actual Study Start Date :||August 3, 2011|
|Primary Completion Date :||July 31, 2017|
|Study Completion Date :||July 31, 2017|
Aloglipin 25 mg, tablets, orally, once daily for up to 12 months
- Frequency of Adverse events [ Time Frame: 36 months ]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 ]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 ]The change in the value of fasting blood glucose collected at month 36 relative to baseline.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01964963
|Study Chair:||Postmarketing Group Manager||Takeda|