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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01316094
First received: March 14, 2011
Last updated: October 16, 2014
Last verified: October 2014

March 14, 2011
October 16, 2014
February 2011
November 2012   (final data collection date for primary outcome measure)
changes in Hemoglobin A1c (HbA1c) [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01316094 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
A Study to Assess Efficacy and Safety of ASP1941 in Diabetic Patients With Renal Impairment
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

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Type 2 Diabetes Mellitus
  • Drug: ASP1941
    oral
  • Drug: placebo
    oral
  • Experimental: ASP group
    Intervention: Drug: ASP1941
  • Placebo Comparator: placebo group
    Intervention: Drug: placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
165
November 2012
November 2012   (final data collection date for primary outcome measure)

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
Both
20 Years to 74 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT01316094
1941-CL-0072
No
Astellas Pharma Inc
Astellas Pharma Inc
Not Provided
Study Chair: Central Contact Astellas Pharma Inc
Astellas Pharma Inc
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP