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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01071850
First received: February 18, 2010
Last updated: October 16, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Diabetes Mellitus, Type 2
Drug: ASP1941
Drug: Metformin
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by Astellas Pharma Inc:

Primary Outcome Measures:
  • Mean change from baseline in Hemoglobin A1c (HbA1c) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Mean change from baseline in fasting plasma glucose (FPG) [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving target goal of HbA1c <7.0% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Proportion of subjects achieving target goal of HbA1c <6.5% [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Enrollment: 412
Study Start Date: March 2010
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: ASP1941 lowest dose Drug: ASP1941
oral tablet
Experimental: ASP1941 low dose Drug: ASP1941
oral tablet
Experimental: ASP1941 high dose Drug: ASP1941
oral tablet
Experimental: ASP1941 highest dose Drug: ASP1941
oral tablet
Active Comparator: Metformin Drug: Metformin
oral tablet
Placebo Comparator: Placebo Drug: Placebo
oral tablet

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01071850

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

Additional Information:
No publications provided by Astellas Pharma Inc

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc
ClinicalTrials.gov Identifier: NCT01071850     History of Changes
Other Study ID Numbers: 1941-CL-0004
Study First Received: February 18, 2010
Last Updated: October 16, 2014
Health Authority: United States: Food and Drug Administration
Mexico: Federal Commission for Protection Against Health Risks
Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos
Peru: Instituto Nacional de Salud
India: Drugs Controller General of India
Philippines: Bureau of Food and Drugs

Keywords provided by Astellas Pharma Inc:
Type 2 diabetes
diabetes
ASP1941
Metformin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Endocrine System Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Metformin
Hypoglycemic Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on October 30, 2014