A Study to Evaluate the Effect of ASP1941 in Adult Patients With Type 2 Diabetes Mellitus
This study has been completed.
Sponsor:
Astellas Pharma Inc
Information provided by (Responsible Party):
Astellas Pharma Inc
ClinicalTrials.gov Identifier:
NCT01071850
First received: February 18, 2010
Last updated: April 29, 2012
Last verified: April 2012
- Full Text View
- Tabular View
- Study Results
- Disclaimer
- How to Read a Study Record
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071850
Hide Study Locations
Hide Study LocationsLocations
| 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 | |
| APEX Medical Research, AMR, Inc | |
| Chicago, Illinois, United States, 60616 | |
| Cedar Crosse Research Center | |
| Chicago, Illinois, United States, 60607 | |
| 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 | |
| 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 | |
| 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 | |
| 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 | |
| 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
No publications provided
| 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: | April 29, 2012 |
| 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 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Metformin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 19, 2013