A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus
Overview[ - collapse ][ - ]
| 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 | Diabetes Mellitus, Type 2 |
| Intervention | Drug: ASP1941 Drug: Metformin Drug: Placebo |
| Phase | Phase 2 |
| Sponsor | Astellas Pharma Inc |
| Responsible Party | Astellas Pharma Inc |
| ClinicalTrials.gov Identifier | NCT01071850 |
| First Received | February 18, 2010 |
| Last Updated | April 29, 2012 |
| Last verified | April 2012 |
Tracking Information[ + expand ][ + ]
| First Received Date | February 18, 2010 |
|---|---|
| Last Updated Date | April 29, 2012 |
| Start Date | March 2010 |
| Estimated Primary Completion Date | April 2011 |
| Current Primary Outcome Measures | Mean change from baseline in Hemoglobin A1c (HbA1c) [Time Frame: 12 weeks] [Designated as safety issue: No] |
| Current Secondary Outcome Measures |
|
Descriptive Information[ + expand ][ + ]
| 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 Subjects With Type 2 Diabetes Mellitus |
| 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. |
| Detailed Description | Not Provided |
| Study Type | Interventional |
| Study Phase | Phase 2 |
| Study Design | Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment |
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | Drug: ASP1941 oral tablet Drug: Metformin oral tablet Drug: Placebo oral tablet |
| Study Arm (s) |
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Recruitment Information[ + expand ][ + ]
| Recruitment Status | Completed |
|---|---|
| Estimated Enrollment | 412 |
| Estimated Completion Date | April 2011 |
| Estimated Primary Completion Date | April 2011 |
| 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 |
| Gender | Both |
| Ages | 18 Years |
| Accepts Healthy Volunteers | No |
| Contacts | Not Provided |
| Location Countries | United States, Colombia, India, Mexico, Philippines |
Administrative Information[ + expand ][ + ]
| NCT Number | NCT01071850 |
|---|---|
| Other Study ID Numbers | 1941-CL-0004 |
| Has Data Monitoring Committee | No |
| Information Provided By | Astellas Pharma Inc |
| Study Sponsor | Astellas Pharma Inc |
| Collaborators | Not Provided |
| Investigators | Study Director: Medical Director Astellas Pharma Global Development |
| Verification Date | April 2012 |
Locations[ + expand ][ + ]
| Parkway Medical Center | Birmingham, Alabama, United States, 35215 |
|---|---|
| Winston Technology Research, LLC | Haleyville, Alabama, United States, 35565 |
| Desert Clinical Research | Mesa, Arizona, United States, 85213 |
| Central Phoenix Medical Clinic | Phoenix, Arizona, United States, 85020 |
| Paul W. Davis, MD, PA | Pine Bluff, Arkansas, United States, 71603 |
| 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 |
| Expresscare Clinical Research | Colorado Springs, Colorado, United States, 80909 |
| 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 |
| 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 |
| APEX Medical Research, AMR, Inc | Chicago, Illinois, United States, 60616 |
| Cedar Crosse Research Center | Chicago, Illinois, United States, 60607 |
| MediSphere Medical Research | Evansville, Indiana, United States, 47714 |
| Bay West Endocrinology | Towson, Maryland, United States, 21204 |
| Prism Research | St. Paul, Minnesota, United States, 55114 |
| PMG Research of Charlotte, LLC | Charlotte, North Carolina, United States, 28209 |
| PMG Research of Salisbury, LLC | Salisbury, North Carolina, United States, 28144 |
| Rapid Medical Research | Cleveland, Ohio, United States, 44122 |
| Primecare of Southeastern Ohio, Inc. | Zanesville, Ohio, United States, 43701 |
| Integris Family Care | Yukon, Oklahoma, United States, 73099 |
| Willamette Valley Clinical Studies | Eugene, Oregon, United States, 97404 |
| Fleetwood Clinical Research | Fleetwood, Pennsylvania, United States, 19522 |
| Southeastern Research Associates, Inc. | Taylors, South Carolina, United States, 29687 |
| 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 |
| 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 |
| Aspen Clinical Research | Orem, Utah, United States, 84058 |
| BIOMELAB | Barranquilla, Colombia |
| Centro de Reumatologia y ortopedia | Barranquilla, Colombia |
| Fundacion de Caribe para le Investigacion Biomedica | Barranquilla, Colombia |
| School of Medicine University of Rosario | Bogota, Colombia |
| Dexa Diad Servicios Medicos | 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 |
| Torre Medica Providencia | Guadalajara, Mexico, 44670 |
| Instituto Jaliscience de Investigacion Clinica | Guadalajara, Mexico, 44100 |
| 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 |