Renal Impairment Study With ASP1941
Primary Purpose
Type 2 Diabetes Mellitus
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ASP1941
Sponsored by
About this trial
This is an interventional basic science trial for Type 2 Diabetes Mellitus focused on measuring Renal Impairment, ASP1941, Pharmacokinetics
Eligibility Criteria
Inclusion Criteria:
- Patient with stable type 2 diabetes mellitus or healthy subject
Subject must have pre-dose estimated Glomerular filtration rate (GFR) values (Modification of diet in renal disease (MDRD) method) at screening of:
- >90 (normal renal function)
- 60-90 (mild renal impairment)
- 30-60 (moderate renal impairment)
- 15-30 (severe renal impairment)
- BMI between 25.0-40.0 kg/m2, inclusive
- Fasted plasma glucose (FPG) <11.5 mmol/l (type 2 DM patients) or >5.6 mmol/l (Healthy volunteers)
Exclusion Criteria:
- Patients with Type 1 diabetes
- Pulse <40 or >90; SBP >160 mmHg; DBP > 100 mmHg
- T2DM patients who are not on a stable regimen for their current medication (1 month or 5 half lives, whichever is longer) to control their disease
- Healthy Volunteers: Any of the liver function tests above the upper limit of normal
T2DM: The liver function tests should be within the following ranges:
- AST/ALT: <2 x ULN
- Bilirubin: <1.5 x ULN
- Alk Phos: < 1.5 x ULN
- Patients with renal impairment who have a history of a clinically significant illness (other than renal diseases and T2DM and associated clinical symptoms), medical condition, or laboratory abnormality within 3 months prior to screening
- Patients with renal impairment who have not been on a stable dose of concomitant medications for at least 2 weeks for at least 2 weeks (or 5 halflives, whichever is longer) and/or for whom dose changes are likely to occur during the study
- Patients with T2DM treated with a diet only
- T2DM patients with recent evidence (e.g within the last 6 months) of severe hypoglycemia, for example plasma glucose < 3mmol/l (<55 mg/dl), help from others to resolve the hypo or requiring hospitalization
- T2DM patients with a Hemoglobin value < 9 g/dl (5.6 mmol/l)
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Active Comparator
Experimental
Experimental
Experimental
Experimental
Arm Label
Healthy volunteers with normal renal function
T2DM patient with normal renal function
T2DM patient with mild renal impairment
T2DM patient with moderate renal impairment
T2DM patient with severe renal impairment
Arm Description
Oral
Oral
Oral
Oral
Oral
Outcomes
Primary Outcome Measures
Effect of grade of renal impairment on the pharmacokinetics of ASP1941
Secondary Outcome Measures
Effect of grade of renal impairment on the pharmacodynamics of ASP1941
Assessment of safety through evaluation of adverse events, physical examination, vital sins, lab-tests and 12-lead ECG
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01302028
Brief Title
Renal Impairment Study With ASP1941
Official Title
An Open-label, Parallel Group Study to Assess the Effect of Different Grades of Renal Impairment in Patients With Type 2 Diabetes Mellitus on the Pharmacokinetics, Pharmacodynamics and Safety & Tolerability of ASP1941 Relative to Type 2 Diabetes Mellitus With Normal Renal Function and Healthy Volunteers
Study Type
Interventional
2. Study Status
Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 22, 2010 (Actual)
Primary Completion Date
June 26, 2010 (Actual)
Study Completion Date
June 26, 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
A study to investigate if the pharmacokinetics of ASP1941 is different in Type 2 Diabetes Mellitus (T2DM) patients with different grades of renal failure compared with T2DM patients with normal renal function and healthy volunteers.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
Keywords
Renal Impairment, ASP1941, Pharmacokinetics
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Healthy volunteers with normal renal function
Arm Type
Active Comparator
Arm Description
Oral
Arm Title
T2DM patient with normal renal function
Arm Type
Experimental
Arm Description
Oral
Arm Title
T2DM patient with mild renal impairment
Arm Type
Experimental
Arm Description
Oral
Arm Title
T2DM patient with moderate renal impairment
Arm Type
Experimental
Arm Description
Oral
Arm Title
T2DM patient with severe renal impairment
Arm Type
Experimental
Arm Description
Oral
Intervention Type
Drug
Intervention Name(s)
ASP1941
Intervention Description
Oral
Primary Outcome Measure Information:
Title
Effect of grade of renal impairment on the pharmacokinetics of ASP1941
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Effect of grade of renal impairment on the pharmacodynamics of ASP1941
Time Frame
5 days
Title
Assessment of safety through evaluation of adverse events, physical examination, vital sins, lab-tests and 12-lead ECG
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Patient with stable type 2 diabetes mellitus or healthy subject
Subject must have pre-dose estimated Glomerular filtration rate (GFR) values (Modification of diet in renal disease (MDRD) method) at screening of:
>90 (normal renal function)
60-90 (mild renal impairment)
30-60 (moderate renal impairment)
15-30 (severe renal impairment)
BMI between 25.0-40.0 kg/m2, inclusive
Fasted plasma glucose (FPG) <11.5 mmol/l (type 2 DM patients) or >5.6 mmol/l (Healthy volunteers)
Exclusion Criteria:
Patients with Type 1 diabetes
Pulse <40 or >90; SBP >160 mmHg; DBP > 100 mmHg
T2DM patients who are not on a stable regimen for their current medication (1 month or 5 half lives, whichever is longer) to control their disease
Healthy Volunteers: Any of the liver function tests above the upper limit of normal
T2DM: The liver function tests should be within the following ranges:
AST/ALT: <2 x ULN
Bilirubin: <1.5 x ULN
Alk Phos: < 1.5 x ULN
Patients with renal impairment who have a history of a clinically significant illness (other than renal diseases and T2DM and associated clinical symptoms), medical condition, or laboratory abnormality within 3 months prior to screening
Patients with renal impairment who have not been on a stable dose of concomitant medications for at least 2 weeks for at least 2 weeks (or 5 halflives, whichever is longer) and/or for whom dose changes are likely to occur during the study
Patients with T2DM treated with a diet only
T2DM patients with recent evidence (e.g within the last 6 months) of severe hypoglycemia, for example plasma glucose < 3mmol/l (<55 mg/dl), help from others to resolve the hypo or requiring hospitalization
T2DM patients with a Hemoglobin value < 9 g/dl (5.6 mmol/l)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Use Central Contact
Organizational Affiliation
Astellas Pharma Europe B.V.
Official's Role
Study Director
Facility Information:
City
Brno
ZIP/Postal Code
62500
Country
Czechia
City
Prague
ZIP/Postal Code
16900
Country
Czechia
City
Balatonfured
ZIP/Postal Code
8230
Country
Hungary
City
Warsaw
ZIP/Postal Code
02-097
Country
Poland
City
Bratislava
ZIP/Postal Code
83305
Country
Slovakia
12. IPD Sharing Statement
Citations:
PubMed Identifier
23359360
Citation
Ferrannini E, Veltkamp SA, Smulders RA, Kadokura T. Renal glucose handling: impact of chronic kidney disease and sodium-glucose cotransporter 2 inhibition in patients with type 2 diabetes. Diabetes Care. 2013 May;36(5):1260-5. doi: 10.2337/dc12-1503. Epub 2013 Jan 28.
Results Reference
derived
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=6
Description
Link to results on Astellas Clinical Study Results website
Learn more about this trial
Renal Impairment Study With ASP1941
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