Diabetes Mellitus, Type 2 Clinical Trial
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
| Verified date | May 2019 |
| Source | Astellas Pharma Inc |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 412 |
| Est. completion date | April 11, 2011 |
| Est. primary completion date | April 11, 2011 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Colombia | BIOMELAB | 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 | |
| India | Diacon Hospital | Bangalore | |
| India | Hormone Care and Research Centre | Ghaziabad | |
| India | TOTALL Diabetes Hormone Institute Pvt.Ltd. | Indore | |
| India | S R Kalla Memorial Gastro & General Hospital | Jaipur | |
| India | Bride, Bharti Hospital | Karnal | |
| India | Amrita Institute of Medical Sciences and Research Centre, AIMS | Kerala | |
| Mexico | Unidad Metabólica y Cardiovascular, SC. | Cuernavaca | |
| Mexico | Instituto Jaliscience de Investigacion Clinica | Guadalajara | |
| Mexico | Torre Medica Providencia | Guadalajara | |
| Mexico | CEDIME, Instituto Vascular | Merida | |
| Mexico | Medical Care and Research | Merida | |
| Mexico | Hospital Universitario Dr. Eleuterio Gonzalez | Monterrey | |
| Philippines | Cebu Doctors' University Hospital | Cebu | |
| Philippines | St. Paul's Hospital | Iloilo City | |
| Philippines | Amang Rodriguez Memorial Medical Center | Marikina City | |
| Philippines | San Juan De Dios Hospital | Pasay City | |
| United States | CSRA Partners in Health, Inc. | Augusta | Georgia |
| United States | Parkway Medical Center | Birmingham | Alabama |
| United States | PAB Clinical Research | Brandon | Florida |
| United States | PMG Research of Bristol, LLC | Bristol | Tennessee |
| United States | Punzi Medical Center | Carrollton | Texas |
| United States | PMG Research of Charlotte, LLC | Charlotte | North Carolina |
| United States | APEX Medical Research, AMR, Inc | Chicago | Illinois |
| United States | Cedar Crosse Research Center | Chicago | Illinois |
| United States | Rapid Medical Research | Cleveland | Ohio |
| United States | Expresscare Clinical Research | Colorado Springs | Colorado |
| United States | Clinical Therapeutics Corp. | Coral Gables | Florida |
| United States | Corpus Christi Family Wellness Center | Corpus Christi | Texas |
| United States | Clinical Innovations, Inc. | Costa Mesa | California |
| United States | Willamette Valley Clinical Studies | Eugene | Oregon |
| United States | MediSphere Medical Research | Evansville | Indiana |
| United States | Fleetwood Clinical Research | Fleetwood | Pennsylvania |
| United States | Winston Technology Research, LLC | Haleyville | Alabama |
| United States | A.G.A Clinical Trials DBA Neostart Group | Hialeah | Florida |
| United States | Excel Clinical Research, LLC | Houston | Texas |
| United States | Del Rosario Medical Clinic, Inc | Huntington Park | California |
| United States | Holston Medical Group | Kingsport | Tennessee |
| United States | Torrance Clinical Research | Lomita | California |
| United States | Southwind Medical Specialist | Memphis | Tennessee |
| United States | Desert Clinical Research | Mesa | Arizona |
| United States | Suncoast Clinical Research | New Port Richey | Florida |
| United States | Aspen Clinical Research | Orem | Utah |
| United States | Central Phoenix Medical Clinic | Phoenix | Arizona |
| United States | Paul W. Davis, MD, PA | Pine Bluff | Arkansas |
| United States | Prism Research | Saint Paul | Minnesota |
| United States | PMG Research of Salisbury, LLC | Salisbury | North Carolina |
| United States | Cetero Research | San Antonio | Texas |
| United States | San Diego Managed Care Group Clinical Research | San Diego | California |
| United States | Southeastern Research Associates, Inc. | Taylors | South Carolina |
| United States | Bay West Endocrinology | Towson | Maryland |
| United States | Atlanta Vascular Research Foundation, Atlanta Cardiology & Primary Care P.C. | Tucker | Georgia |
| United States | Integris Family Care | Yukon | Oklahoma |
| United States | Primecare of Southeastern Ohio, Inc. | Zanesville | Ohio |
| Lead Sponsor | Collaborator |
|---|---|
| Astellas Pharma Inc |
United States, Colombia, India, Mexico, Philippines,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Mean change from baseline in Hemoglobin A1c (HbA1c) | 12 weeks | ||
| Secondary | Mean change from baseline in fasting plasma glucose (FPG) | 12 weeks | ||
| Secondary | Proportion of subjects achieving target goal of HbA1c <7.0% | 12 weeks | ||
| Secondary | Proportion of subjects achieving target goal of HbA1c <6.5% | 12 weeks |
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