Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"
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|ClinicalTrials.gov Identifier: NCT01945216|
Recruitment Status : Completed
First Posted : September 18, 2013
Results First Posted : November 8, 2018
Last Update Posted : November 8, 2018
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|
|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. Participants will receive the drug as part of routine medical care.
|Study Type :||Observational|
|Actual Enrollment :||3317 participants|
|Official Title:||Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"|
|Actual Study Start Date :||July 8, 2010|
|Actual Primary Completion Date :||October 31, 2015|
|Actual Study Completion Date :||October 31, 2015|
|Alogliptin 25mg, tablets, orally, once daily, up to 36 months||
Other Name: Nesina; SYR-322
- Number of Participants Who Experience at Least One Adverse Events [ Time Frame: Up to Month 36 ]
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to 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 Baseline in Fasting Blood Glucose [ Time Frame: Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36) ]The change in the value of fasting blood glucose collected at month 36 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): NCT01945216
|Study Director:||Study Director||Takeda|