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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01316094
Recruitment Status : Completed
First Posted : March 16, 2011
Last Update Posted : January 20, 2016
Information provided by (Responsible Party):
Astellas Pharma Inc

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 Type : Interventional  (Clinical Trial)
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 - 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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: ASP group Drug: ASP1941

Placebo Comparator: placebo group Drug: placebo

Primary Outcome Measures :
  1. changes in Hemoglobin A1c (HbA1c) [ Time Frame: baseline and 24 weeks ]

Secondary Outcome Measures :
  1. changes in fasting plasma glucose [ Time Frame: baseline and 24 weeks ]
  2. changes in fasting serum insulin level [ Time Frame: baseline and 24 weeks ]
  3. changes in eGFR (estimated glomerular filtration rate) [ Time Frame: baseline and 52 weeks ]
  4. safety assessed by the incidence of adverse events, vital signs, laboratory tests and 12-lead ECGs [ Time Frame: for 52 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01316094

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

Additional Information:
Responsible Party: Astellas Pharma Inc Identifier: NCT01316094     History of Changes
Other Study ID Numbers: 1941-CL-0072
First Posted: March 16, 2011    Key Record Dates
Last Update Posted: January 20, 2016
Last Verified: January 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Astellas Pharma Inc:
Renal impairment

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