Study Stopped
Discontinued due to company's strategic reason
A Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus
A Phase III, Double-Blind, Randomized, Active Controlled, Monotherapy Study to Assess the Efficacy and Safety of ASP1941 in Asian Subjects With Type 2 Diabetes Mellitus
1 other identifier
interventional
46
2 countries
15
Brief Summary
The purpose of this study is to assess the efficacy of ASP1941 based on the changes in HbA1C as well as its safety 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 below P25 for phase_3
Started Apr 2012
Shorter than P25 for phase_3
15 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
First Submitted
Initial submission to the registry
January 18, 2012
CompletedFirst Posted
Study publicly available on registry
January 23, 2012
CompletedStudy Start
First participant enrolled
April 23, 2012
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
CompletedNovember 12, 2024
November 1, 2024
6 months
January 18, 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 body 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)
1941 group
EXPERIMENTALOnce daily over a 24-week treatment period
acarbose group
ACTIVE COMPARATOROnce daily over a 24-week treatment period
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 6 weeks before the study
- for the hypoglycemic agent non-naïve subject, subject has been receiving a single hypoglycemic agent or low-dose of a dual combination therapy
- BMI of 20.0 to 45.0 kg/m2
- for the hypoglycemic agent non-naïve subject, subject has a HbA1c value between 6.8 and 10.0% at screening AND has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period
- for the hypoglycemic agent naïve subject, subject has a HbA1c value between 7.0 and 10.0%, inclusive, at run-in period
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, acarbose or other alpha-GI
- 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 (15)
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
Seongnam, South Korea
Unknown Facility
Seoul, South Korea
Unknown Facility
Wŏnju, South Korea
Unknown Facility
Changha, Taiwan
Unknown Facility
Chiayi City, Taiwan
Unknown Facility
Kaohsiung City, Taiwan
Unknown Facility
Taichung, Taiwan
Unknown Facility
Tainan, Taiwan
Unknown Facility
Taipei, Taiwan
Unknown Facility
Taoyuan District, Taiwan
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 18, 2012
First Posted
January 23, 2012
Study Start
April 23, 2012
Primary Completion
October 19, 2012
Study Completion
October 19, 2012
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/.