A Study of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
A Phase 1, Randomized, Double-blind, Placebo Controlled, Monotherapy Study to Assess the Pharmacodynamics, Pharmacokinetics, Safety and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus
1 other identifier
interventional
30
1 country
1
Brief Summary
The primary purpose of this study is to evaluate the pharmacodynamic profile (blood glucose and urinary glucose excursion) of ASP1941 in patients with type 2 diabetes mellitus. Safety, tolerability and pharmacokinetics are also evaluated.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_1 type-2-diabetes-mellitus
Started Nov 2009
1 active site
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 7, 2009
CompletedFirst Submitted
Initial submission to the registry
November 30, 2009
CompletedFirst Posted
Study publicly available on registry
December 2, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 26, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 26, 2010
CompletedNovember 12, 2024
November 1, 2024
5 months
November 30, 2009
November 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in plasma glucose levels
On day 14
Secondary Outcomes (4)
Urinary glucose excursion
On day 14
Pharmacokinetic parameter of ASP1941
On day 14
Safety by adverse events, routine safety laboratories and vital signs.
During treatment
Change in serum insulin levels
On day 14
Study Arms (3)
ASP1941 high dose group
EXPERIMENTALoral
ASP1941 low dose 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% at screening
- Fasting plasma glucose ≥ 126mg/dL and \< 240mg/dL at screening
- 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
- Significant renal, hepatic or cardiovascular diseases
- Severe gastrointestinal diseases
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Unknown Facility
Kantou, Japan
Related Publications (1)
Toyoshima J, Saito M, Kaibara A, Isaka H, Sakatani T. Comparison of the Pharmacokinetic and Pharmacodynamic Relationship of Ipragliflozin Between Patients With Type 1 and Type 2 Diabetes Mellitus. Clin Ther. 2020 Sep;42(9):1787-1798.e3. doi: 10.1016/j.clinthera.2020.07.009. Epub 2020 Aug 21.
PMID: 32839028DERIVED
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 1
- 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
November 30, 2009
First Posted
December 2, 2009
Study Start
November 7, 2009
Primary Completion
March 26, 2010
Study Completion
March 26, 2010
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/.