A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus

May 20, 2025 updated by: Astellas Pharma Inc

A Phase 2, Double-Blind, Randomized, Placebo and Active-Controlled Dose-Finding Study to Assess the Efficacy, Safety and Tolerability of Multiple Oral Doses of ASP1941 in Patients With Type 2 Diabetes Mellitus

Evaluate the efficacy, safety, and tolerability of multiple doses of ASP1941 compared to placebo over 12 weeks of therapy in adult patients with type 2 diabetes mellitus.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
412

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

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

  • Colombia
      • Barranquilla, Colombia
        • Biomelab
      • Barranquilla, Colombia
        • Centro de Reumatologia y Ortopedia
      • Barranquilla, Colombia
        • Fundacion de Caribe para le Investigacion Biomedica
      • Bogota, Colombia
        • Dexa Diad Servicios Medicos
      • Bogota, Colombia
        • School of Medicine University of Rosario
      • Floridablanca Santander, Colombia
        • Fundacion Cardiovascular de Columbia
  • India
      • Bangalore, India, 560010
        • Diacon Hospital
      • Ghaziabad, India, 201002
        • Hormone Care and Research Centre
      • Indore, India, 452001
        • TOTALL Diabetes Hormone Institute Pvt.Ltd.
      • Jaipur, India, 302001
        • S R Kalla Memorial Gastro & General Hospital
      • Karnal, India, 132001
        • Bride, Bharti Hospital
      • Kerala, India, 682041
        • Amrita Institute of Medical Sciences and Research Centre, AIMS
  • Mexico
      • Cuernavaca, Mexico, 62250
        • Unidad Metabólica y Cardiovascular, SC.
      • Guadalajara, Mexico, 44100
        • Instituto Jaliscience de Investigacion Clinica
      • Guadalajara, Mexico, 44670
        • Torre Medica Providencia
      • Merida, Mexico, 97070
        • Medical Care and Research
      • Merida, Mexico, 97129
        • CEDIME, Instituto Vascular
      • Monterrey, Mexico, 66460
        • Hospital Universitario Dr. Eleuterio Gonzalez
  • Philippines
      • Cebu, Philippines, 6000
        • Cebu Doctors' University Hospital
      • Iloilo City, Philippines, 5000
        • St. Paul's Hospital
      • Marikina City, Philippines, 1800
        • Amang Rodriguez Memorial Medical Center
      • Pasay City, Philippines, 1300
        • San Juan De Dios Hospital
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35215
        • Parkway Medical Center
      • Haleyville, Alabama, United States, 35565
        • Winston Technology Research, LLC
    • Arizona
      • Mesa, Arizona, United States, 85213
        • Desert Clinical Research
      • Phoenix, Arizona, United States, 85020
        • Central Phoenix Medical Clinic
    • Arkansas
      • Pine Bluff, Arkansas, United States, 71603
        • Paul W. Davis, MD, PA
    • California
      • Costa Mesa, California, United States, 92626
        • Clinical Innovations, Inc.
      • Huntington Park, California, United States, 90255
        • Del Rosario Medical Clinic, Inc
      • Lomita, California, United States, 90717
        • Torrance Clinical Research
      • San Diego, California, United States, 92128
        • San Diego Managed Care Group Clinical Research
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Expresscare Clinical Research
    • Florida
      • Brandon, Florida, United States, 33511
        • PAB Clinical Research
      • Coral Gables, Florida, United States, 33131
        • Clinical Therapeutics Corp.
      • Hialeah, Florida, United States, 33012
        • A.G.A Clinical Trials DBA Neostart Group
      • New Port Richey, Florida, United States, 34652
        • Suncoast Clinical Research
    • Georgia
      • Augusta, Georgia, United States, 30909
        • CSRA Partners in Health, Inc.
      • Tucker, Georgia, United States, 30084
        • Atlanta Vascular Research Foundation, Atlanta Cardiology & Primary Care P.C.
    • Illinois
      • Chicago, Illinois, United States, 60607
        • Cedar Crosse Research Center
      • Chicago, Illinois, United States, 60616
        • APEX Medical Research, AMR, Inc
    • Indiana
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research
    • Maryland
      • Towson, Maryland, United States, 21204
        • Bay West Endocrinology
    • Minnesota
      • Saint Paul, Minnesota, United States, 55114
        • Prism Research
    • North Carolina
      • Charlotte, North Carolina, United States, 28209
        • PMG Research of Charlotte, LLC
      • Salisbury, North Carolina, United States, 28144
        • PMG Research of Salisbury, LLC
    • Ohio
      • Cleveland, Ohio, United States, 44122
        • Rapid Medical Research
      • Zanesville, Ohio, United States, 43701
        • Primecare of Southeastern Ohio, Inc.
    • Oklahoma
      • Yukon, Oklahoma, United States, 73099
        • Integris Family Care
    • Oregon
      • Eugene, Oregon, United States, 97404
        • Willamette Valley Clinical Studies
    • Pennsylvania
      • Fleetwood, Pennsylvania, United States, 19522
        • Fleetwood Clinical Research
    • South Carolina
      • Taylors, South Carolina, United States, 29687
        • Southeastern Research Associates, Inc.
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • PMG Research of Bristol, LLC
      • Kingsport, Tennessee, United States, 37660
        • Holston Medical Group
      • Memphis, Tennessee, United States, 38125
        • Southwind Medical Specialist
    • Texas
      • Carrollton, Texas, United States, 75006
        • Punzi Medical Center
      • Corpus Christi, Texas, United States, 78414
        • Corpus Christi Family Wellness Center
      • Houston, Texas, United States, 77081
        • Excel Clinical Research, LLC
      • San Antonio, Texas, United States, 78229
        • Cetero Research
    • Utah
      • Orem, Utah, United States, 84058
        • Aspen Clinical Research

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Subject has been diagnosed with type 2 diabetes
  • Subject has a HbA1c value between 6.8 and 9.5%
  • Subject has never, is not currently taking anti-diabetic medication OR is receiving a single anti- diabetic agent or low-doses two anti-diabetic medications and is willing to discontinue them during the study
  • Subject is on a stable diet and exercise program
  • Female subject is not pregnant and agrees to use an acceptable form of contraception throughout the duration of the study

Exclusion Criteria:

  • Subject has type 1 diabetes mellitus
  • Subject is using insulin therapy
  • Subject has a serum creatinine higher than upper limit of normal
  • Subject has an ALT and/or AST value higher than 3 times upper limit of normal or a total bilirubin value more than 2 times upper limit of normal
  • Subject has persistent, uncontrolled severe hypertension as indicated by a

systolic blood pressure >180 mmHg or a diastolic blood pressure of

>110mmHg

  • Subject has had significant cardiovascular disease such as myocardial infarction or a vascular intervention (e.g., angioplasty or stent) in the last 3 months
  • Subject is known to have hepatitis or be a carrier of hepatitis B surface

antigen, hepatitis C virus antibody or is known positive for HIV1 and/or

HIV2

  • Subject has a history of lactic acidosis
  • Subject has a history of drug and alcohol abuse/dependency within last 12

months

  • Subject has had a malignancy in the last 5 years, except for successfully

treated basal or squamous cell carcinoma of the skin or of the cervix

  • Subject has a symptomatic urinary tract infection or genital infection
  • Female subject is lactating
  • Subject has an unstable medical or psychiatric illness

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: ASP1941 lowest dose
oral tablet
Drug: ipragliflozin
oral tablet
Other Names:
  • ASP1941
Experimental: ASP1941 low dose
oral tablet
Drug: ipragliflozin
oral tablet
Other Names:
  • ASP1941
Experimental: ASP1941 high dose
oral tablet
Drug: ipragliflozin
oral tablet
Other Names:
  • ASP1941
Experimental: ASP1941 highest dose
oral tablet
Drug: ipragliflozin
oral tablet
Other Names:
  • ASP1941
Active Comparator: Metformin
oral tablet
Drug: Metformin
oral tablet
Placebo Comparator: Placebo
oral tablet
Drug: Placebo
oral tablet

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Mean change from baseline in Hemoglobin A1c (HbA1c)
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Mean change from baseline in fasting plasma glucose (FPG)
Time Frame: 12 weeks
12 weeks
Proportion of subjects achieving target goal of HbA1c <7.0%
Time Frame: 12 weeks
12 weeks
Proportion of subjects achieving target goal of HbA1c <6.5%
Time Frame: 12 weeks
12 weeks

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Astellas Pharma Inc

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Astellas Pharma Global Development

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 3, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 11, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 11, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 18, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 18, 2010

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 19, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 20, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1941-CL-0004

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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