Back to resultsA Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
Japan
Study Type
Interventional
Intervention
ASP1941
Sponsored by
About this trial
This is an interventional other trial for Type 2 Diabetes Mellitus focused on measuring Urinary glucose excretion, Diabetes mellitus, ASP1941
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
Normal renal function group
Mild renal impairment group
Moderate renal impairment group
Arm Description
oral
oral
oral
Outcomes
Primary Outcome Measures
Plasma concentration of ASP1941
Secondary Outcome Measures
Urinary levels of ASP1941
Urinary glucose excretion
Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01097681
Brief Title
A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2018
Overall Recruitment Status
Completed
Study Start Date
February 16, 2010 (Actual)
Primary Completion Date
June 18, 2010 (Actual)
Study Completion Date
June 18, 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Urinary glucose excretion, Diabetes mellitus, ASP1941
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Normal renal function group
Arm Type
Experimental
Arm Description
oral
Arm Title
Mild renal impairment group
Arm Type
Experimental
Arm Description
oral
Arm Title
Moderate renal impairment group
Arm Type
Experimental
Arm Description
oral
Intervention Type
Drug
Intervention Name(s)
ASP1941
Intervention Description
oral
Primary Outcome Measure Information:
Title
Plasma concentration of ASP1941
Time Frame
For 72 hours after dosing
Secondary Outcome Measure Information:
Title
Urinary levels of ASP1941
Time Frame
For 72 hours after dosing
Title
Urinary glucose excretion
Time Frame
For 72 hours after dosing
Title
Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs
Time Frame
For 72 hours after dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
79 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Inc
Official's Role
Study Chair
Facility Information:
City
Kansai
Country
Japan
City
Kantou
Country
Japan
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
Access to anonymized individual participant level data will not be provided for this trial as it meets one or more of the exceptions described on www.clinicalstudydatarequest.com under "Sponsor Specific Details for Astellas."
Links:
URL
https://astellasclinicalstudyresults.com/study.aspx?ID=92
Description
Link to results on Astellas Clinical Study Results Web site
Learn more about this trial
A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment
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