A Study to Assess the Efficacy and Safety of ASP1941 in Japanese Type 2 Diabetes Patients
Phase III Study of ASP1941 -A Phase III, Randomized, Double-Blind, Placebo-controlled, Monotherapy Study to Assess the Efficacy, Safety, and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
130
1 country
5
Brief Summary
This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese patients with type 2 diabetes mellitus.
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
Shorter than P25 for phase_3 type-2-diabetes-mellitus
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2010
CompletedFirst Submitted
Initial submission to the registry
January 25, 2010
CompletedFirst Posted
Study publicly available on registry
January 27, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 6, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
November 6, 2010
CompletedMay 30, 2025
May 1, 2025
10 months
January 25, 2010
May 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change from baseline in HbA1c
16 weeks
Secondary Outcomes (3)
change from baseline in fasting plasma glucose
16 weeks
change from baseline in fasting serum insulin
16 weeks
safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)
During treatment
Study Arms (2)
ASP1941 group
EXPERIMENTALoral
placebo group
PLACEBO COMPARATORoral
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetic patients for at least 12 weeks
- HbA1c value between 7.0 and 10.0%
- Body Mass Index (BMI) 20.0 - 45.0 kg/m2
- Investigator adjudicates that a subject is able to discontinue currently taking hypoglycemic agents safely during treatment
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kansai, Japan
Unknown Facility
Kantou, Japan
Unknown Facility
Kyushu, Japan
Unknown Facility
Tōhoku, Japan
Related Publications (1)
Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.
PMID: 31606880DERIVED
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
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 25, 2010
First Posted
January 27, 2010
Study Start
January 13, 2010
Primary Completion
November 6, 2010
Study Completion
November 6, 2010
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/.