A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Long-term Study of ASP1941 - Study to Assess the Efficacy and Safety of ASP1941 in Patients With Type 2 Diabetes Mellitus Who Have Renal Impairment|
- changes in Hemoglobin A1c (HbA1c) [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
- changes in fasting plasma glucose [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
- changes in fasting serum insulin level [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
- changes in eGFR (estimated glomerular filtration rate) [ Time Frame: baseline and 52 weeks ] [ Designated as safety issue: No ]
- safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs [ Time Frame: for 52 weeks ] [ Designated as safety issue: No ]
|Study Start Date:||February 2011|
|Study Completion Date:||November 2012|
|Primary Completion Date:||November 2012 (Final data collection date for primary outcome measure)|
|Experimental: ASP group||
|Placebo Comparator: placebo group||
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 Chair:||Central Contact||Astellas Pharma Inc|