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

Study Overview
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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.

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.

Official Title
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Long-term Study of ASP1941 - Long-term Study in Patients With Type 2 Diabetes Mellitus With Decreased Renal Function (Japanese)

Conditions
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Type 2 Diabetes Mellitus

Intervention / Treatment
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* Drug: ASP1941
* Drug: placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 74 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP group<br>oral | Drug: ASP1941<br>* oral<br>|
| Placebo Comparator: placebo group<br>oral | Drug: placebo<br>* oral<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in Hemoglobin A1c (HbA1c) |  | baseline and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in fasting plasma glucose |  | baseline and 24 weeks | 
| changes in fasting serum insulin level |  | baseline and 24 weeks | 
| changes in eGFR (estimated glomerular filtration rate) |  | baseline and 52 weeks | 
| safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs |  | for 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pharmacokinetics, ASP1941, Renal impairment