Renal Impairment Study With ASP1941

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01302028

Collaborator

(none)

Enrollment

Locations

Arms

5.1

Actual Duration (Months)

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: ASP1941	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

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

Actual Study Start Date :

Jan 22, 2010

Actual Primary Completion Date :

Jun 26, 2010

Actual Study Completion Date :

Jun 26, 2010

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Healthy volunteers with normal renal function Oral	Drug: ASP1941 Oral
Experimental: T2DM patient with normal renal function Oral	Drug: ASP1941 Oral
Experimental: T2DM patient with mild renal impairment Oral	Drug: ASP1941 Oral
Experimental: T2DM patient with moderate renal impairment Oral	Drug: ASP1941 Oral
Experimental: T2DM patient with severe renal impairment Oral	Drug: ASP1941 Oral

Outcome Measures

Primary Outcome Measures

Effect of grade of renal impairment on the pharmacokinetics of ASP1941 [5 days]

Secondary Outcome Measures

Effect of grade of renal impairment on the pharmacodynamics of ASP1941 [5 days]
Assessment of safety through evaluation of adverse events, physical examination, vital sins, lab-tests and 12-lead ECG [5 days]

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)