A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
An Open-Label Study to Assess the Effect of Different Grades of Renal Impairment in Japanese Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus Patients With Normal Renal Function
1 other identifier
interventional
25
1 country
2
Brief Summary
The primary objective of this study is to compare the pharmacokinetics of ASP1941 in type 2 diabetes mellitus patients with normal renal function and those with mild or moderate renal impairment.
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 Feb 2010
2 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
February 16, 2010
CompletedFirst Submitted
Initial submission to the registry
March 31, 2010
CompletedFirst Posted
Study publicly available on registry
April 2, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 18, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 18, 2010
CompletedNovember 12, 2024
November 1, 2024
4 months
March 31, 2010
November 8, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma concentration of ASP1941
For 72 hours after dosing
Secondary Outcomes (3)
Urinary levels of ASP1941
For 72 hours after dosing
Urinary glucose excretion
For 72 hours after dosing
Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs
For 72 hours after dosing
Study Arms (3)
Normal renal function group
EXPERIMENTALoral
Mild renal impairment group
EXPERIMENTALoral
Moderate renal impairment group
EXPERIMENTALoral
Interventions
oral
Eligibility Criteria
You may qualify if:
- Type 2 diabetic patients for at least 12 weeks
- Fasting plasma glucose level of \< 240 mg/dL
- Body Mass Index ( BMI )20.0 - 35.0kg/m2
- GFR value based on the Japanese GFR estimation equation at screening, of ≥ 30 ml/min/1.73m2
You may not qualify if:
- Type 1 diabetes mellitus patients
- Receiving insulin within 12 weeks before screening
- Diabetic ketoacidosis
- 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 (2)
Unknown Facility
Kansai, Japan
Unknown Facility
Kantou, Japan
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
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 31, 2010
First Posted
April 2, 2010
Study Start
February 16, 2010
Primary Completion
June 18, 2010
Study Completion
June 18, 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/.