A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment

Astellas

Status and phase

Completed

Phase 3

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: placebo

Drug: ASP1941

Study type

Interventional

Funder types

Industry

Identifiers

NCT01316094

1941-CL-0072

Details and patient eligibility

About

This study is to assess the effect of renal function on the efficacy and safety of ASP1941 in type 2 diabetic patients with mild to moderate renal impairment.

Full description

This study will be conducted in patients with type 2 diabetes mellitus and mild to moderate renal impairment who have inadequate glycemic control on an exercise program and stable diet, or one oral hypoglycemic agent.

The severity of the reduction in renal function in each subject will be classified according to the glomerular filtration rate (GFR) estimated using the Japanese GFR estimation equation. Subjects will start with a screening period, followed by a single-blind placebo run-in period, and will be randomized to the ASP1941 groups or the placebo group at a ratio of 2:1. For randomization, subjects will be stratified according to the severity of the reduction in renal function. In a treatment period, subject will receive study drug or placebo for 24 weeks under double-blind conditions.

At 24 week, subjects who are willing to continue participation in the study will receive study drug for another 28 weeks in an open label condition. ASP1941 can be increased. After completion of the study drug administration, a follow-up period will be provided.

Enrollment

165 patients

Sex

All

Ages

20 to 74 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

type 2 diabetes mellitus patient
subject has been on an exercise program and stable diet, or one oral hypoglycemic agent (alpha-glucosidase inhibitor, sulfonylurea agent and pioglitazone)
estimated GFR value based on the Japanese GFR estimation equation of ≥ 30 mL/min/1.73 m2 and < 90 mL/min/1.73 m2
HbA1C value between 6.5 and 8.5%
body mass index (BMI) 29.0 - 45.0 kg/m2

Exclusion criteria

type 1 diabetes mellitus patients
proliferative diabetic retinopathy
subject has received insulin within 12 weeks before the study
subject has a chronic disease which requires the continuous use of adrenocortical steroids, immunosuppressant, and loop diuretic
serum creatinine > upper limit of normal
proteinuria (albumin/creatinine ratio > 300mg/g)
dysuria and/or urinary tract infection, genital infection
significant renal, hepatic or cardiovascular diseases
severe gastrointestinal diseases