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

Sponsor

Astellas Pharma Inc (Industry)

Overall Status

Completed

CT.gov ID

NCT01316094

Collaborator

(none)

165

Enrollment

Locations

Arms

22.3

Actual Duration (Months)

20.6

Patients Per Site

0.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes Mellitus	Drug: ASP1941 Drug: placebo	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

165 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 18, 2011

Actual Primary Completion Date :

Nov 28, 2012

Actual Study Completion Date :

Nov 28, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ASP group oral	Drug: ASP1941 oral
Placebo Comparator: placebo group oral	Drug: placebo oral

Arm

Intervention/Treatment

Experimental: ASP group

oral

Drug: ASP1941

oral

Placebo Comparator: placebo group

oral

Drug: placebo

oral

Outcome Measures

Primary Outcome Measures

changes in Hemoglobin A1c (HbA1c) [baseline and 24 weeks]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 74 Years

Sexes Eligible for Study:

All

Accepts 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