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

Astellas

Status and phase: Completed; Phase 1

Conditions: Type 2 Diabetes Mellitus

Treatments: Drug: ASP1941

Study type: Interventional

Funder types: Industry

Identifiers

NCT01097681

1941-CL-0073

Details and patient eligibility

About

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.

Enrollment: 25 patients

Sex: All

Ages: 20 to 79 years old

Volunteers: No 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 3 patient groups

Normal renal function group

Experimental group

Description:

oral

Treatment:

Drug: ASP1941

Mild renal impairment group

Experimental group

Description:

oral

Treatment:

Drug: ASP1941

Moderate renal impairment group

Experimental group

Description:

oral

Treatment:

Drug: ASP1941