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

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

PHASE3

Total Enrollment

165 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-18

Study Completion Date

2012-11-28

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Type 2 Diabetes Mellitus

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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ASP group

oral

Group Type EXPERIMENTAL

ASP1941

Intervention Type DRUG

oral

placebo group

oral

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral

Interventions

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ASP1941

oral

Intervention Type DRUG

placebo

oral

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

74 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No