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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
  Purpose

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 Intervention Phase
Type 2 Diabetes Mellitus
Drug: ASP1941
Drug: placebo
Phase 3

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • changes in Hemoglobin A1c (HbA1c) [ Time Frame: baseline and 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 165
Study Start Date: February 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP group Drug: ASP1941
oral
Placebo Comparator: placebo group Drug: placebo
oral

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.

  Eligibility

Ages Eligible for Study:   20 Years to 74 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01316094

Locations
Japan
Chubu, Japan
Chugoku, Japan
Hokkaido, Japan
Kansai, Japan
Kantou, Japan
Kyushu, Japan
Shikoku, Japan
Touhoku, Japan
Sponsors and Collaborators
Astellas Pharma Inc
Investigators
Study Chair: Central Contact Astellas Pharma Inc
  More Information

Additional Information:
No publications provided

Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01316094     History of Changes
Other Study ID Numbers: 1941-CL-0072
Study First Received: March 14, 2011
Last Updated: October 16, 2014
Health Authority: Japan: Pharmaceuticals and Medical Devices Agency

Keywords provided by Astellas Pharma Inc:
Renal impairment
ASP1941
Pharmacokinetics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Renal Insufficiency
Endocrine System Diseases
Glucose Metabolism Disorders
Kidney Diseases
Metabolic Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on November 25, 2014