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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01071850
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : November 21, 2017
Information provided by (Responsible Party):
Astellas Pharma Inc

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Drug: ASP1941 Drug: Metformin Drug: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 412 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Actual Study Start Date : March 3, 2010
Actual Primary Completion Date : April 11, 2011
Actual Study Completion Date : April 11, 2011

Resource links provided by the National Library of Medicine

Drug Information available for: Metformin
U.S. FDA Resources

Arm Intervention/treatment
Experimental: ASP1941 lowest dose
oral tablet
Drug: ASP1941
oral tablet
Experimental: ASP1941 low dose
oral tablet
Drug: ASP1941
oral tablet
Experimental: ASP1941 high dose
oral tablet
Drug: ASP1941
oral tablet
Experimental: ASP1941 highest dose
oral tablet
Drug: ASP1941
oral tablet
Active Comparator: Metformin
oral tablet
Drug: Metformin
oral tablet
Placebo Comparator: Placebo
oral tablet
Drug: Placebo
oral tablet

Primary Outcome Measures :
  1. Mean change from baseline in Hemoglobin A1c (HbA1c) [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Mean change from baseline in fasting plasma glucose (FPG) [ Time Frame: 12 weeks ]
  2. Proportion of subjects achieving target goal of HbA1c <7.0% [ Time Frame: 12 weeks ]
  3. Proportion of subjects achieving target goal of HbA1c <6.5% [ Time Frame: 12 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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


  • 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


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


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01071850

  Hide Study 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
Saint 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
Barranquilla, Colombia
Centro de Reumatologia y ortopedia
Barranquilla, Colombia
Fundacion de Caribe para le Investigacion Biomedica
Barranquilla, Colombia
Dexa Diad Servicios Medicos
Bogota, Colombia
School of Medicine University of Rosario
Bogota, Colombia
Fundacion Cardiovascular de Columbia
Floridablanca Santander, Colombia
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
Unidad Metabólica y Cardiovascular, SC.
Cuernavaca, Mexico, 62250
Instituto Jaliscience de Investigacion Clinica
Guadalajara, Mexico, 44100
Torre Medica Providencia
Guadalajara, Mexico, 44670
Medical Care and Research
Merida, Mexico, 97070
CEDIME, Instituto Vascular
Merida, Mexico, 97129
Hospital Universitario Dr. Eleuterio Gonzalez
Monterrey, Mexico, 66460
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
Study Director: Medical Director Astellas Pharma Global Development

Additional Information:
Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Astellas Pharma Inc Identifier: NCT01071850     History of Changes
Other Study ID Numbers: 1941-CL-0004
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: November 21, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Details of the IPD sharing plan for this study can be found at
URL: http://

Keywords provided by Astellas Pharma Inc:
Type 2 diabetes

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