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NCT01097681 Clinical Trial

A Study to Assess the Pharmacokinetics, Pharmacodynamics of ASP1941 in Diabetes Mellitus Patients With Renal Impairment

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01097681
Other study ID # 1941-CL-0073
Secondary ID
Status Completed
Phase Phase 1
First received
Last updated
Start date February 16, 2010
Est. completion date June 18, 2010

Study information
Verified date October 2018
Source Astellas Pharma Inc
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 25
Est. completion date June 18, 2010
Est. primary completion date June 18, 2010
Accepts healthy volunteers No
Gender All
Age group 20 Years to 79 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• ASP1941
oral

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Astellas Pharma Inc

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Plasma concentration of ASP1941 For 72 hours after dosing
Secondary Urinary levels of ASP1941 For 72 hours after dosing
Secondary Urinary glucose excretion For 72 hours after dosing
Secondary Safety assessed by adverse events, vital signs, laboratory tests and 12-lead ECGs For 72 hours after dosing
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