Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"
|ClinicalTrials.gov Identifier: NCT01945216|
Recruitment Status : Completed
First Posted : September 18, 2013
Last Update Posted : July 13, 2016
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.
|Condition or disease||Intervention/treatment|
|Patients With Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution||Drug: Alogliptin|
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.
|Study Type :||Observational|
|Actual Enrollment :||3317 participants|
|Official Title:||Nesina Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||July 2015|
|Actual Study Completion Date :||July 2015|
|Aloglipin 25mg, tablets, orally, once daily, up to 36 months||
Other Name: Nesina; SYR-322
- Frequency of Adverse event [ 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): NCT01945216
|Study Chair:||Postmarketing Group Manager||Takeda|