Clinical trial NCT01071850: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetes Mellitus, Type 2
Keywords: ASP1941
Metformin
Type 2 diabetes
diabetes
Lead sponsor: Astellas Pharma Inc
Sponsor class: INDUSTRY
First posted: 2010-02-19
Enrollment: 412
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Mean change from baseline in Hemoglobin A1c (HbA1c)
timeFrame: 12 weeks
Secondary outcomes:
measure: Mean change from baseline in fasting plasma glucose (FPG)
timeFrame: 12 weeks
measure: Proportion of subjects achieving target goal of HbA1c <7.0%
timeFrame: 12 weeks
measure: Proportion of subjects achieving target goal of HbA1c <6.5%
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Parkway Medical Center
state: Alabama
city: Haleyville
country: United States
facility: Winston Technology Research, LLC
state: Alabama
city: Mesa
country: United States
facility: Desert Clinical Research
state: Arizona
city: Phoenix
country: United States
facility: Central Phoenix Medical Clinic
state: Arizona
city: Pine Bluff
country: United States
facility: Paul W. Davis, MD, PA
state: Arkansas
city: Costa Mesa
country: United States
facility: Clinical Innovations, Inc.
state: California
city: Huntington Park
country: United States
facility: Del Rosario Medical Clinic, Inc
state: California
city: Lomita
country: United States
facility: Torrance Clinical Research
state: California
city: San Diego
country: United States
facility: San Diego Managed Care Group Clinical Research
state: California
city: Colorado Springs
country: United States
facility: Expresscare Clinical Research
state: Colorado
city: Brandon
country: United States
facility: PAB Clinical Research
state: Florida
city: Coral Gables
country: United States
facility: Clinical Therapeutics Corp.
state: Florida
city: Hialeah
country: United States
facility: A.G.A Clinical Trials DBA Neostart Group
state: Florida
city: New Port Richey
country: United States
facility: Suncoast Clinical Research
state: Florida
city: Augusta
country: United States
facility: CSRA Partners in Health, Inc.
state: Georgia
city: Tucker
country: United States
facility: Atlanta Vascular Research Foundation, Atlanta Cardiology & Primary Care P.C.
state: Georgia
city: Chicago
country: United States
facility: Cedar Crosse Research Center
state: Illinois
city: Chicago
country: United States
facility: APEX Medical Research, AMR, Inc
state: Illinois
city: Evansville
country: United States
facility: MediSphere Medical Research
state: Indiana
city: Towson
country: United States
facility: Bay West Endocrinology
state: Maryland
city: Saint Paul
country: United States
facility: Prism Research
state: Minnesota
city: Charlotte
country: United States
facility: PMG Research of Charlotte, LLC
state: North Carolina
city: Salisbury
country: United States
facility: PMG Research of Salisbury, LLC
state: North Carolina
city: Cleveland
country: United States
facility: Rapid Medical Research
state: Ohio
city: Zanesville
country: United States
facility: Primecare of Southeastern Ohio, Inc.
state: Ohio
city: Yukon
country: United States
facility: Integris Family Care
state: Oklahoma
city: Eugene
country: United States
facility: Willamette Valley Clinical Studies
state: Oregon
city: Fleetwood
country: United States
facility: Fleetwood Clinical Research
state: Pennsylvania
city: Taylors
country: United States
facility: Southeastern Research Associates, Inc.
state: South Carolina
city: Bristol
country: United States
facility: PMG Research of Bristol, LLC
state: Tennessee
city: Kingsport
country: United States
facility: Holston Medical Group
state: Tennessee
city: Memphis
country: United States
facility: Southwind Medical Specialist
state: Tennessee
city: Carrollton
country: United States
facility: Punzi Medical Center
state: Texas
city: Corpus Christi
country: United States
facility: Corpus Christi Family Wellness Center
state: Texas
city: Houston
country: United States
facility: Excel Clinical Research, LLC
state: Texas
city: San Antonio
country: United States
facility: Cetero Research
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research
state: Utah
city: Barranquilla
country: Colombia
facility: BIOMELAB
city: Barranquilla
country: Colombia
facility: Centro de Reumatologia y ortopedia
city: Barranquilla
country: Colombia
facility: Fundacion de Caribe para le Investigacion Biomedica
city: Bogota
country: Colombia
facility: Dexa Diad Servicios Medicos
city: Bogota
country: Colombia
facility: School of Medicine University of Rosario
city: Floridablanca Santander
country: Colombia
facility: Fundacion Cardiovascular de Columbia
city: Bangalore
country: India
facility: Diacon Hospital
city: Ghaziabad
country: India
facility: Hormone Care and Research Centre
city: Indore
country: India
facility: TOTALL Diabetes Hormone Institute Pvt.Ltd.
city: Jaipur
country: India
facility: S R Kalla Memorial Gastro & General Hospital
city: Karnal
country: India
facility: Bride, Bharti Hospital
city: Kerala
country: India
facility: Amrita Institute of Medical Sciences and Research Centre, AIMS
city: Cuernavaca
country: Mexico
facility: Unidad Metabólica y Cardiovascular, SC.
city: Guadalajara
country: Mexico
facility: Instituto Jaliscience de Investigacion Clinica
city: Guadalajara
country: Mexico
facility: Torre Medica Providencia
city: Merida
country: Mexico
facility: Medical Care and Research
city: Merida
country: Mexico
facility: CEDIME, Instituto Vascular
city: Monterrey
country: Mexico
facility: Hospital Universitario Dr. Eleuterio Gonzalez
city: Cebu
country: Philippines
facility: Cebu Doctors' University Hospital
city: Iloilo City
country: Philippines
facility: St. Paul's Hospital
city: Marikina City
country: Philippines
facility: Amang Rodriguez Memorial Medical Center
city: Pasay City
country: Philippines
facility: San Juan De Dios Hospital
Study officials:
affiliation: Astellas Pharma Global Development
name: Medical Director
role: STUDY_DIRECTOR
References:
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.
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.