A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Diabetes Patients
A Phase III, Double-Blind, Randomized, Placebo-Controlled Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Asian Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone
1 other identifier
interventional
171
2 countries
12
Brief Summary
To compare the efficacy and safety of ASP1941 + metformin with metformin alone in Asian subjects with type 2 diabetes mellitus.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2011
Shorter than P25 for phase_3
12 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
November 28, 2011
CompletedFirst Submitted
Initial submission to the registry
January 4, 2012
CompletedFirst Posted
Study publicly available on registry
January 6, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 14, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
January 14, 2013
CompletedNovember 12, 2024
November 1, 2024
1.1 years
January 4, 2012
November 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in HbA1c from baseline to end of treatment
Baseline and up to 24 weeks
Secondary Outcomes (5)
Change in fasting plasma glucose level
Baseline and up to 24 weeks
Change in fasting serum insulin level
Baseline and up to 24 weeks
Change in body weight
Baseline and up to 24 weeks
Change in waist circumference
Baseline and up to 24 weeks
Safety assessed by the incidence of adverse events, vital signs safety labo-tests and 12-lead ECG
For 24 weeks
Study Arms (2)
ASP1941 group
EXPERIMENTALASP1941 + metformin
placebo group
PLACEBO COMPARATORplacebo + metformin
Interventions
Eligibility Criteria
You may qualify if:
- Diagnosed as type 2 diabetes mellitus patient at least 12 weeks before the study
- Stable diet and exercise program for at least 8 weeks before the study
- On a stable dose of at least 1500 mg/day metformin monotherapy or at least 1000 mg/day metformin monotherapy for the subject who can not titrate up to 1500 mg/day due to safety concern of metformin
- BMI of 20.0 to 45.0 kg/m2
- A HbA1c value between 7.0 and 10.0% at screening AND does not meet any of discontinuation criteria on fasting plasma glucose
You may not qualify if:
- Type 1 diabetes mellitus
- Proliferative diabetic retinopathy
- Receiving insulin within 12 weeks prior to the study
- History of clinically significant renal disease(s)
- Significant dysuria caused by a neurogenic bladder or a benign prostate hypertrophy etc.
- Urinary tract infection or genital infection
- Continuous use of systemic corticosteroids, immunosuppressants, or loop diuretics
- History of cerebrovascular attack, unstable angina, myocardial infarction, angioplasty, serious cardiac diseases within 12 weeks prior to the study
- Severe infection, serious trauma, or perioperative subject
- Known or suspected hypersensitivity to ASP1941
- History of treatment with ASP1941
- Participated in another clinical study, postmarketing study or medical device study within 12 weeks before the study
- Serum creatinine value exceeding the upper limit of normal range
- Urinary microalbumin/urinary creatinine ratio \>300 mg/g
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (12)
Unknown Facility
Busan, South Korea
Unknown Facility
Daegu, South Korea
Unknown Facility
Daejeon, South Korea
Unknown Facility
Gwangju, South Korea
Unknown Facility
Incheon, South Korea
Unknown Facility
Jeonju, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Wŏnju, South Korea
Unknown Facility
Kaohsiung City, Taiwan
Unknown Facility
Taichung, Taiwan
Unknown Facility
Tainan, Taiwan
Unknown Facility
Taipei, Taiwan
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)
Intervention 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 4, 2012
First Posted
January 6, 2012
Study Start
November 28, 2011
Primary Completion
January 14, 2013
Study Completion
January 14, 2013
Last Updated
November 12, 2024
Record last verified: 2024-11
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/.