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

May 19, 2025 updated by: Astellas Pharma Inc

Long-term Study of ASP1941 - Long-term Study in Patients With Type 2 Diabetes Mellitus With Decreased Renal Function (Japanese)

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

165

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Chubu, Japan
      • Chugoku, Japan
      • Hokkaido, Japan
      • Kansai, Japan
      • Kantou, Japan
      • Kyushu, Japan
      • Shikoku, Japan
      • Touhoku, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 74 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: placebo group
oral
Drug: placebo
oral
Experimental: ASP group
oral
Drug: ASP1941
oral

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
changes in Hemoglobin A1c (HbA1c)
Time Frame: baseline and 24 weeks
baseline and 24 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
changes in fasting plasma glucose
Time Frame: baseline and 24 weeks
baseline and 24 weeks
changes in fasting serum insulin level
Time Frame: baseline and 24 weeks
baseline and 24 weeks
changes in eGFR (estimated glomerular filtration rate)
Time Frame: baseline and 52 weeks
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
for 52 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astellas Pharma Inc

Investigators

  • Study Chair: Central Contact, Astellas Pharma Inc

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 18, 2011

Primary Completion (Actual)

November 28, 2012

Study Completion (Actual)

November 28, 2012

Study Registration Dates

First Submitted

March 14, 2011

First Submitted That Met QC Criteria

March 14, 2011

First Posted (Estimated)

March 16, 2011

Study Record Updates

Last Update Posted (Actual)

May 22, 2025

Last Update Submitted That Met QC Criteria

May 19, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1941-CL-0072

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Access to anonymized individual participant level data will not be provided for this trial. Further details on Astellas' data sharing policy can be found at https://www.clinicaltrials.astellas.com/transparency/.

IPD Sharing Time Frame

Access to participant level data is offered to researchers after publication of the primary manuscript (if applicable) and is available as long as Astellas has legal authority to provide the data.

IPD Sharing Access Criteria

Researchers must submit a proposal to conduct a scientifically relevant analysis of the study data. The research proposal is reviewed by an Independent Research Panel. If the proposal is approved, access to the study data is provided in a secure data sharing environment after receipt of a signed Data Sharing Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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