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

Primary Purpose

Diabetes Mellitus, Type 2

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ipragliflozin
Metformin
Placebo
Sponsored by
Astellas Pharma Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring ASP1941, Metformin, Type 2 diabetes, diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Parkway Medical Center
  • Winston Technology Research, LLC
  • Desert Clinical Research
  • Central Phoenix Medical Clinic
  • Paul W. Davis, MD, PA
  • Clinical Innovations, Inc.
  • Del Rosario Medical Clinic, Inc
  • Torrance Clinical Research
  • San Diego Managed Care Group Clinical Research
  • Expresscare Clinical Research
  • PAB Clinical Research
  • Clinical Therapeutics Corp.
  • A.G.A Clinical Trials DBA Neostart Group
  • Suncoast Clinical Research
  • CSRA Partners in Health, Inc.
  • Atlanta Vascular Research Foundation, Atlanta Cardiology & Primary Care P.C.
  • Cedar Crosse Research Center
  • APEX Medical Research, AMR, Inc
  • MediSphere Medical Research
  • Bay West Endocrinology
  • Prism Research
  • PMG Research of Charlotte, LLC
  • PMG Research of Salisbury, LLC
  • Rapid Medical Research
  • Primecare of Southeastern Ohio, Inc.
  • Integris Family Care
  • Willamette Valley Clinical Studies
  • Fleetwood Clinical Research
  • Southeastern Research Associates, Inc.
  • PMG Research of Bristol, LLC
  • Holston Medical Group
  • Southwind Medical Specialist
  • Punzi Medical Center
  • Corpus Christi Family Wellness Center
  • Excel Clinical Research, LLC
  • Cetero Research
  • Aspen Clinical Research
  • BIOMELAB
  • Centro de Reumatologia y ortopedia
  • Fundacion de Caribe para le Investigacion Biomedica
  • Dexa Diad Servicios Medicos
  • School of Medicine University of Rosario
  • Fundacion Cardiovascular de Columbia
  • Diacon Hospital
  • Hormone Care and Research Centre
  • TOTALL Diabetes Hormone Institute Pvt.Ltd.
  • S R Kalla Memorial Gastro & General Hospital
  • Bride, Bharti Hospital
  • Amrita Institute of Medical Sciences and Research Centre, AIMS
  • Unidad Metabólica y Cardiovascular, SC.
  • Instituto Jaliscience de Investigacion Clinica
  • Torre Medica Providencia
  • Medical Care and Research
  • CEDIME, Instituto Vascular
  • Hospital Universitario Dr. Eleuterio Gonzalez
  • Cebu Doctors' University Hospital
  • St. Paul's Hospital
  • Amang Rodriguez Memorial Medical Center
  • San Juan De Dios Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Placebo Comparator

Arm Label

ASP1941 lowest dose

ASP1941 low dose

ASP1941 high dose

ASP1941 highest dose

Metformin

Placebo

Arm Description

oral tablet

oral tablet

oral tablet

oral tablet

oral tablet

oral tablet

Outcomes

Primary Outcome Measures

Mean change from baseline in Hemoglobin A1c (HbA1c)

Secondary Outcome Measures

Mean change from baseline in fasting plasma glucose (FPG)
Proportion of subjects achieving target goal of HbA1c <7.0%
Proportion of subjects achieving target goal of HbA1c <6.5%

Full Information

First Posted
February 18, 2010
Last Updated
May 20, 2019
Sponsor
Astellas Pharma Inc
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1. Study Identification

Unique Protocol Identification Number
NCT01071850
Brief Title
A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 3, 2010 (Actual)
Primary Completion Date
April 11, 2011 (Actual)
Study Completion Date
April 11, 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Astellas Pharma Inc

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
ASP1941, Metformin, Type 2 diabetes, diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
412 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ASP1941 lowest dose
Arm Type
Experimental
Arm Description
oral tablet
Arm Title
ASP1941 low dose
Arm Type
Experimental
Arm Description
oral tablet
Arm Title
ASP1941 high dose
Arm Type
Experimental
Arm Description
oral tablet
Arm Title
ASP1941 highest dose
Arm Type
Experimental
Arm Description
oral tablet
Arm Title
Metformin
Arm Type
Active Comparator
Arm Description
oral tablet
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
oral tablet
Intervention Type
Drug
Intervention Name(s)
ipragliflozin
Other Intervention Name(s)
ASP1941
Intervention Description
oral tablet
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
oral tablet
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
oral tablet
Primary Outcome Measure Information:
Title
Mean change from baseline in Hemoglobin A1c (HbA1c)
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Mean change from baseline in fasting plasma glucose (FPG)
Time Frame
12 weeks
Title
Proportion of subjects achieving target goal of HbA1c <7.0%
Time Frame
12 weeks
Title
Proportion of subjects achieving target goal of HbA1c <6.5%
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Astellas Pharma Global Development
Official's Role
Study Director
Facility Information:
Facility Name
Parkway Medical Center
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Winston Technology Research, LLC
City
Haleyville
State/Province
Alabama
ZIP/Postal Code
35565
Country
United States
Facility Name
Desert Clinical Research
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85213
Country
United States
Facility Name
Central Phoenix Medical Clinic
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Paul W. Davis, MD, PA
City
Pine Bluff
State/Province
Arkansas
ZIP/Postal Code
71603
Country
United States
Facility Name
Clinical Innovations, Inc.
City
Costa Mesa
State/Province
California
ZIP/Postal Code
92626
Country
United States
Facility Name
Del Rosario Medical Clinic, Inc
City
Huntington Park
State/Province
California
ZIP/Postal Code
90255
Country
United States
Facility Name
Torrance Clinical Research
City
Lomita
State/Province
California
ZIP/Postal Code
90717
Country
United States
Facility Name
San Diego Managed Care Group Clinical Research
City
San Diego
State/Province
California
ZIP/Postal Code
92128
Country
United States
Facility Name
Expresscare Clinical Research
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
Country
United States
Facility Name
PAB Clinical Research
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Clinical Therapeutics Corp.
City
Coral Gables
State/Province
Florida
ZIP/Postal Code
33131
Country
United States
Facility Name
A.G.A Clinical Trials DBA Neostart Group
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33012
Country
United States
Facility Name
Suncoast Clinical Research
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
CSRA Partners in Health, Inc.
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30909
Country
United States
Facility Name
Atlanta Vascular Research Foundation, Atlanta Cardiology & Primary Care P.C.
City
Tucker
State/Province
Georgia
ZIP/Postal Code
30084
Country
United States
Facility Name
Cedar Crosse Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60607
Country
United States
Facility Name
APEX Medical Research, AMR, Inc
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60616
Country
United States
Facility Name
MediSphere Medical Research
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Bay West Endocrinology
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
Facility Name
Prism Research
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55114
Country
United States
Facility Name
PMG Research of Charlotte, LLC
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
PMG Research of Salisbury, LLC
City
Salisbury
State/Province
North Carolina
ZIP/Postal Code
28144
Country
United States
Facility Name
Rapid Medical Research
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Primecare of Southeastern Ohio, Inc.
City
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
Country
United States
Facility Name
Integris Family Care
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
Willamette Valley Clinical Studies
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Fleetwood Clinical Research
City
Fleetwood
State/Province
Pennsylvania
ZIP/Postal Code
19522
Country
United States
Facility Name
Southeastern Research Associates, Inc.
City
Taylors
State/Province
South Carolina
ZIP/Postal Code
29687
Country
United States
Facility Name
PMG Research of Bristol, LLC
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Holston Medical Group
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Southwind Medical Specialist
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38125
Country
United States
Facility Name
Punzi Medical Center
City
Carrollton
State/Province
Texas
ZIP/Postal Code
75006
Country
United States
Facility Name
Corpus Christi Family Wellness Center
City
Corpus Christi
State/Province
Texas
ZIP/Postal Code
78414
Country
United States
Facility Name
Excel Clinical Research, LLC
City
Houston
State/Province
Texas
ZIP/Postal Code
77081
Country
United States
Facility Name
Cetero Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Aspen Clinical Research
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
Facility Name
BIOMELAB
City
Barranquilla
Country
Colombia
Facility Name
Centro de Reumatologia y ortopedia
City
Barranquilla
Country
Colombia
Facility Name
Fundacion de Caribe para le Investigacion Biomedica
City
Barranquilla
Country
Colombia
Facility Name
Dexa Diad Servicios Medicos
City
Bogota
Country
Colombia
Facility Name
School of Medicine University of Rosario
City
Bogota
Country
Colombia
Facility Name
Fundacion Cardiovascular de Columbia
City
Floridablanca Santander
Country
Colombia
Facility Name
Diacon Hospital
City
Bangalore
ZIP/Postal Code
560010
Country
India
Facility Name
Hormone Care and Research Centre
City
Ghaziabad
ZIP/Postal Code
201002
Country
India
Facility Name
TOTALL Diabetes Hormone Institute Pvt.Ltd.
City
Indore
ZIP/Postal Code
452001
Country
India
Facility Name
S R Kalla Memorial Gastro & General Hospital
City
Jaipur
ZIP/Postal Code
302001
Country
India
Facility Name
Bride, Bharti Hospital
City
Karnal
ZIP/Postal Code
132001
Country
India
Facility Name
Amrita Institute of Medical Sciences and Research Centre, AIMS
City
Kerala
ZIP/Postal Code
682041
Country
India
Facility Name
Unidad Metabólica y Cardiovascular, SC.
City
Cuernavaca
ZIP/Postal Code
62250
Country
Mexico
Facility Name
Instituto Jaliscience de Investigacion Clinica
City
Guadalajara
ZIP/Postal Code
44100
Country
Mexico
Facility Name
Torre Medica Providencia
City
Guadalajara
ZIP/Postal Code
44670
Country
Mexico
Facility Name
Medical Care and Research
City
Merida
ZIP/Postal Code
97070
Country
Mexico
Facility Name
CEDIME, Instituto Vascular
City
Merida
ZIP/Postal Code
97129
Country
Mexico
Facility Name
Hospital Universitario Dr. Eleuterio Gonzalez
City
Monterrey
ZIP/Postal Code
66460
Country
Mexico
Facility Name
Cebu Doctors' University Hospital
City
Cebu
ZIP/Postal Code
6000
Country
Philippines
Facility Name
St. Paul's Hospital
City
Iloilo City
ZIP/Postal Code
5000
Country
Philippines
Facility Name
Amang Rodriguez Memorial Medical Center
City
Marikina City
ZIP/Postal Code
1800
Country
Philippines
Facility Name
San Juan De Dios Hospital
City
Pasay City
ZIP/Postal Code
1300
Country
Philippines

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Access to anonymized individual participant level data collected during the study, in addition to study-related supporting documentation, is planned for studies conducted with approved product indications and formulations, as well as compounds terminated during development. Studies conducted with product indications or formulations that remain active in development are assessed after study completion to determine if Individual Participant Data can be shared. Conditions and exceptions are described under the Sponsor Specific Details for Astellas on www.clinicalstudydatarequest.com.
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 URL
https://www.clinicalstudydatarequest.com/
Citations:
PubMed Identifier
31606880
Citation
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.
Results Reference
derived
PubMed Identifier
23276620
Citation
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.
Results Reference
derived
Links:
URL
https://www.astellasclinicalstudyresults.com/study.aspx?ID=1
Description
Link to results on Astellas Clinical Study Results website

Learn more about this trial

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

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