Alogliptin Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus
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|ClinicalTrials.gov Identifier: NCT01964963|
Recruitment Status : Completed
First Posted : October 17, 2013
Results First Posted : May 9, 2019
Last Update Posted : November 21, 2019
|Condition or disease||Intervention/treatment|
|Type 2 Diabetes Mellitus||Drug: Alogliptin|
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:||Alogliptin (Nesina) Tablets Special Drug Use Surveillance: Mild Type 2 Diabetes Mellitus|
|Actual Study Start Date :||August 3, 2011|
|Actual Primary Completion Date :||July 31, 2017|
|Actual Study Completion Date :||July 31, 2017|
Alogliptin 25 mg, tablets, orally, once daily for up to 12 months. Participants will receive interventions as part of routine medical care.
- Percentage of Participants Who Had One or More Adverse Events [ Time Frame: Up to Month 36 ]
- Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, and final assessment point (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 final assessment point (up to Month 36) relative to baseline.
- Change From Baseline in Fasting Blood Glucose [ Time Frame: Baseline, and final assessment point (up to Month 36) ]The change in the value of fasting blood glucose level collected at final assessment point (up to 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): NCT01964963
|Study Director:||Study Director||Takeda|