A Study to Assess the Long-term Safety and Efficacy of ASP1941 in Japanese Diabetic Patients
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
1 other identifier
interventional
182
1 country
7
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 type-2-diabetes-mellitus
Started Jan 2010
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 14, 2010
CompletedFirst Submitted
Initial submission to the registry
January 20, 2010
CompletedFirst Posted
Study publicly available on registry
January 22, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 22, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
July 22, 2011
CompletedMay 30, 2025
May 1, 2025
1.5 years
January 20, 2010
May 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
HbA1c
For 52 weeks
Secondary Outcomes (4)
Fasting plasma glucose
For 52 weeks
Fasting serum insulin
For 52 weeks
Plasma levels of ASP1941 for population PK analysis
For 52 weeks
Safety assessed by adverse events, vital signs laboratory tests and 12-lead ECGs
For 52 weeks
Study Arms (2)
before meal group
EXPERIMENTALASP1941 will be administered before meal
after meal group
EXPERIMENTALASP1941 will be administered after meal
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetic patients for at least 12 weeks
- HbA1c value between 6.5 and 9.5%
- Body Mass Index ( BMI )20.0 - 45.0kg/m2
You may not qualify if:
- Type 1 diabetes mellitus patients
- Serum creatinine \> upper limit of normal
- Proteinuria (albumin/creatinine ratio \> 300mg/g)
- Dysuria and/or urinary tract infection, genital infection
- Significant renal, hepatic or cardiovascular diseases
- Severe gastrointestinal diseases
- Proliferative diabetic retinopathy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Chugoku, Japan
Unknown Facility
Chūbu, Japan
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kansai, Japan
Unknown Facility
Kantou, Japan
Unknown Facility
Kyushu, Japan
Unknown Facility
Tōhoku, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Use Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 20, 2010
First Posted
January 22, 2010
Study Start
January 14, 2010
Primary Completion
July 22, 2011
Study Completion
July 22, 2011
Last Updated
May 30, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share
Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.