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

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: Completed
• Conditions: Diabetes Mellitus, Type 2
• Intervention / Treatment: Drug: Placebo; Drug: ipragliflozin; Drug: Metformin

• Study Type: Interventional
• Enrollment (Actual): 412
• Phase: Phase 2

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Mean change from baseline in Hemoglobin A1c (HbA1c)	12 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline in fasting plasma glucose (FPG)	12 weeks
Proportion of subjects achieving target goal of HbA1c <7.0%	12 weeks
Proportion of subjects achieving target goal of HbA1c <6.5%	12 weeks

Collaborators and Investigators

• Sponsor: Astellas Pharma Inc
• Investigators: Study Director: Medical Director, Astellas Pharma Global Development

Publications and helpful links

General Publications

• Kashiwagi A, Shestakova MV, Ito Y, Noguchi M, Wilpshaar W, Yoshida S, Wilding JPH. Safety of Ipragliflozin in Patients with Type 2 Diabetes Mellitus: Pooled Analysis of Phase II/III/IV Clinical Trials. Diabetes Ther. 2019 Dec;10(6):2201-2217. doi: 10.1007/s13300-019-00699-8. Epub 2019 Oct 12.
• Fonseca VA, Ferrannini E, Wilding JP, Wilpshaar W, Dhanjal P, Ball G, Klasen S. Active- and placebo-controlled dose-finding study to assess the efficacy, safety, and tolerability of multiple doses of ipragliflozin in patients with type 2 diabetes mellitus. J Diabetes Complications. 2013 May-Jun;27(3):268-73. doi: 10.1016/j.jdiacomp.2012.11.005. Epub 2012 Dec 29.

Helpful Links

• Link to results on Astellas Clinical Study Results website

Study record dates

Study Major Dates

• Study Start (Actual): March 3, 2010
• Primary Completion (Actual): April 11, 2011
• Study Completion (Actual): April 11, 2011

Study Registration Dates

• First Submitted: February 18, 2010
• First Submitted That Met QC Criteria: February 18, 2010
• First Posted (Estimated): February 19, 2010

Study Record Updates

• Last Update Posted (Actual): May 22, 2025
• Last Update Submitted That Met QC Criteria: May 20, 2025
• Last Verified: May 1, 2025

More Information

Terms related to this study

• Keywords: diabetes; Type 2 diabetes; Metformin; ASP1941
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; Metformin; Ipragliflozin
• Other Study ID 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