Ignite Creation Date:
2025-12-24 @ 3:53 PM
Ignite Modification Date:
2025-12-29 @ 5:52 PM
Study NCT ID:
NCT01054092
Status:
COMPLETED
Last Update Posted:
2025-05-30
First Post:
2010-01-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Assess the Long-term Safety and Efficacy of ASP1941 in Japanese Diabetic Patients
Sponsor:
Astellas Pharma Inc
Organization:
Study Overview
Official Title:
Long-term Study of ASP1941 - A Phase III, Open-Label, Uncontrolled, Monotherapy Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
Status:
COMPLETED
Status Verified Date:
2025-05
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 primary objective of this study is to evaluate the long-term safety of ASP1941 in patients with type 2 diabetes mellitus. The second objectives are to compare the efficacy and pharmacokinetics of ASP1941 administered before or after food intake.
Detailed Description:
Subject will be randomized into either ASP1941 before meal or ASP1941 after meal groups. Subjects will undergo a screening period before entering the long-term treatment. Dosage may be increased during the treatment period if subjects fulfill increasing criteria and the investigators adjudicate that no impact for subjects safety.
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?: