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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01097681

Enrollment

Registered

2010-04-02

Start date

2010-02-16

Completion date

2010-06-18

Last updated

2024-11-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes Mellitus

Keywords

Urinary glucose excretion, Diabetes mellitus, ASP1941

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.

Interventions

DRUGASP1941

oral

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

20 Years to 79 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Plasma concentration of ASP1941	For 72 hours after dosing

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026