Ignite Creation Date:
2025-12-24 @ 4:48 PM
Ignite Modification Date:
2026-01-04 @ 4:37 PM
Study NCT ID:
NCT01964950
Status:
COMPLETED
Last Update Posted:
2017-04-13
First Post:
2013-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Alogliptin Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea
Sponsor:
Takeda
Organization:
Study Overview
Official Title:
Nesina Tablets Special Drug Use Surveillance Type 2 Diabetes Mellitus: Combination Therapy With Sulfonylurea
Status:
COMPLETED
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine the safety and efficacy of long-term combination therapy with alogliptin (Nesina) and sulfonylurea in participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy.
Detailed Description:
This is a special drug use surveillance on long-term use of alogliptin with a 1-year (12-month) observational period, designed to investigate the safety and efficacy of long-term combination therapy with alogliptin and sulfonylurea in participants with type 2 diabetes mellitus in a routine clinical setting.
Participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy will be enrolled in this study. The planned sample size is 1,000.
The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.
Participants with type 2 diabetes mellitus who responded inadequately to treatment with sulfonylurea in addition to diet therapy and exercise therapy will be enrolled in this study. The planned sample size is 1,000.
The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: