A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment
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|ClinicalTrials.gov Identifier: NCT01316094|
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : January 20, 2016
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus||Drug: ASP1941 Drug: placebo||Phase 3|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||165 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Study Start Date :||February 2011|
|Actual Primary Completion Date :||November 2012|
|Actual Study Completion Date :||November 2012|
|Experimental: ASP group||
|Placebo Comparator: placebo group||
- changes in Hemoglobin A1c (HbA1c) [ Time Frame: baseline and 24 weeks ]
- changes in fasting plasma glucose [ Time Frame: baseline and 24 weeks ]
- changes in fasting serum insulin level [ Time Frame: baseline and 24 weeks ]
- changes in eGFR (estimated glomerular filtration rate) [ Time Frame: baseline and 52 weeks ]
- safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs [ Time Frame: for 52 weeks ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01316094
|Study Chair:||Central Contact||Astellas Pharma Inc|