A Study to Assess Safety and Efficacy of ASP1941 in Combination With Nateglinide in Type 2 Diabetic Patients
Phase III Study of ASP1941 - Open-label, Non-comparative Study to Assess the Long-term Safety, Tolerability and Efficacy of ASP1941 in Combination With Nateglinide in Japanese Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control With Nateglinide Alone
1 other identifier
interventional
122
1 country
4
Brief Summary
This study is to evaluate long-term safety and efficacy after concomitant administration of ASP1941 and Nateglinide inhibitor 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 2011
4 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 15, 2011
CompletedFirst Submitted
Initial submission to the registry
March 14, 2011
CompletedFirst Posted
Study publicly available on registry
March 16, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 19, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
October 19, 2012
CompletedMay 30, 2025
May 1, 2025
1.8 years
March 14, 2011
May 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
change from baseline in hemoglobin A1c (HbA1c)
baseline and for 24 weeks
Secondary Outcomes (3)
change from baseline in fasting plasma glucose
baseline and for 24 weeks
change from baseline in fasting serum insulin
baseline and for 24 weeks
Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs)
for 52 weeks
Study Arms (1)
ASP group
EXPERIMENTALConcomitant administration of ASP1941 and nateglinide
Interventions
Eligibility Criteria
You may qualify if:
- Type 2 diabetic patients receiving with Nateglinide mono-therapy for at least 4 weeks
- HbA1c value between 6.5 and 9.5%
- Body Mass Index (BMI) 20.0 - 45.0 kg/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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
Hokkaido, Japan
Unknown Facility
Kantou, Japan
Unknown Facility
Kyushu, Japan
Unknown Facility
Tōhoku, Japan
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Central Contact
Astellas Pharma Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 14, 2011
First Posted
March 16, 2011
Study Start
January 15, 2011
Primary Completion
October 19, 2012
Study Completion
October 19, 2012
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/.