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

Phase 3

Completed

• Conditions: Type 2 Diabetes Mellitus
• Interventions: Drug: ASP1941; Drug: placebo

• Registration Number: NCT01316094
• Lead Sponsor: Astellas Pharma Inc

Brief Summary

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

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.

Study Timeline

• Study Start: 2011-01-18
• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-16
• Primary Completion: 2012-11-28
• Study Completion: 2012-11-28
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-19
• Last Update Posted: 2025-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 165

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ASP group	ASP1941	oral
placebo group	placebo	oral

Primary Outcome Measures

Name	Time	Method
changes in Hemoglobin A1c (HbA1c)	baseline and 24 weeks

Secondary Outcome Measures

Name	Time	Method
changes in fasting serum insulin level	baseline and 24 weeks
changes in fasting plasma glucose	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