Renal Impairment Study With ASP1941

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-01-22

Study Completion Date

2010-06-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Healthy volunteers with normal renal function

Oral

Group Type ACTIVE_COMPARATOR

ASP1941

Intervention Type DRUG

Oral

T2DM patient with normal renal function

Oral

Group Type EXPERIMENTAL

ASP1941

Intervention Type DRUG

Oral

T2DM patient with mild renal impairment

Oral

Group Type EXPERIMENTAL

ASP1941

Intervention Type DRUG

Oral

T2DM patient with moderate renal impairment

Oral

Group Type EXPERIMENTAL

ASP1941

Intervention Type DRUG

Oral

T2DM patient with severe renal impairment

Oral

Group Type EXPERIMENTAL

ASP1941

Intervention Type DRUG

Oral

Interventions

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ASP1941

Oral

Intervention Type DRUG

Eligibility Criteria

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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)

Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes