A Study of BMS-512148 (Dapagliflozin) in Patients With Type 2 Diabetes and Inadequately Controlled Hypertension on an Angiotensin-Converting Enzyme Inhibitor or Angiotensin Receptor Blocker
Launched by ASTRAZENECA · Jun 3, 2010
Trial Information
Current as of May 23, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- • Key inclusion criteria
- • Participants willing and able to give signed and written informed consent
- • Males and females, aged 18 to 89 years, who have type 2 diabetes with inadequate glycemic control (hemoglobin A1c between 7% and 10.5%) and uncontrolled hypertension (seated systolic blood pressure of 140 to 165 mm Hg and seated diastolic blood pressure 85 to 105 mm Hg)
- • Mean 24-hour BP\>=130/80 mmHg determined by ABPM
- • Stable dose of oral antidiabetic agent (OAD) for at least 6 weeks (12 weeks for thiazolidinedione) or a stable daily dose of insulin as monotherapy or in combination with another OAD, for 8 weeks, and a stable dose of an angiotensin-converting enzyme inhibitor or angiotensin-receptor blocker for at least 4 weeks
- • C-peptide level ≥0.8 ng/mL
- • Body mass index ≤ 45.0 kg/m\^2
- • Key exclusion criteria
- • Aspartate aminotransferase or alanine aminotransferase level \>3\*upper limit of normal (ULN)
- • Serum total bilirubin level \>1.5\*ULN
- • Serum creatinine ≥2.0 mg/dL unless subject was on metformin, where exclusionary limits were serum creatinine ≥1.50 mg/dL for men and ≥1.40 mg/dL for women
- • Estimated creatinine clearance of \<60 mL/min
- • Hemoglobin ≤10.0 g/dL for men and ≤9.0 g/dL for women
- • Creatine kinase \>3\*ULN
- • Positive for hepatitis B surface antigen
- • Positive for antihepatitis C virus antibody
- • Abnormal free T4 value
- • History of diabetes insipidus
- • Symptoms of poorly controlled diabetes that would preclude participation in this trial, including but not limited to, marked polyuria and polydipsia with greater than 10% weight loss during the 3 months prior to enrollment.
- • History of diabetic ketoacidosis or hyperosmolar nonketotic coma
- • History of malignant and accelerated hypertension
- • Known or suspected secondary hypertension
- * Any of the following within 6 months of enrollment visit:
- • Myocardial infarction
- • Cardiac surgery or revascularization (coronary artery bypass surgery /percutaneous transluminal coronary angioplasty)
- • Unstable angina
- • Unstable congestive heart disease or New York Heart Association Class III or IV
- • Transient ischemic attack or significant cerebrovascular disease
- • Unstable or previously undiagnosed arrhythmia
About Astrazeneca
AstraZeneca is a global biopharmaceutical company dedicated to the discovery, development, and commercialization of innovative medicines across various therapeutic areas, including oncology, cardiovascular, respiratory, and autoimmune diseases. With a strong commitment to scientific research and patient-centric solutions, AstraZeneca leverages cutting-edge technology and a robust pipeline to address unmet medical needs. The company collaborates with healthcare professionals, academic institutions, and other organizations to advance clinical trials and deliver transformative therapies, aiming to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Birmingham, Alabama, United States
Portland, Oregon, United States
Coral Gables, Florida, United States
Springfield, Illinois, United States
St. Louis, Missouri, United States
Philadelphia, Pennsylvania, United States
Smolensk, , Russian Federation
Oklahoma City, Oklahoma, United States
Salt Lake City, Utah, United States
Jenkintown, Pennsylvania, United States
Los Angeles, California, United States
Canal Fulton, Ohio, United States
Reading, Pennsylvania, United States
Barcelona, , Spain
Ponce, , Puerto Rico
Cincinnati, Ohio, United States
New Port Richey, Florida, United States
Tustin, California, United States
Bangor, Maine, United States
Phoenix, Arizona, United States
Monterrey, Nuevo Leon, Mexico
Havirov, , Czech Republic
Hyderabad, Andhra Pradesh, India
Saratov, , Russian Federation
San Juan, , Puerto Rico
Huntington Park, California, United States
Roswell, Georgia, United States
Pittsburgh, Pennsylvania, United States
Saskatoon, Saskatchewan, Canada
Waterbury, Connecticut, United States
Yaroslavl, , Russian Federation
Yaroslav, , Russian Federation
Fountain Valley, California, United States
Northridge, California, United States
Perrysburg, Ohio, United States
Bradenton, Florida, United States
Chicago, Illinois, United States
New Braunfels, Texas, United States
San Antonio, Texas, United States
Magdeburg, , Germany
Mainz, , Germany
Mannheim, , Germany
Eger, , Hungary
Szentes, , Hungary
Merida, Yucatan, Mexico
Moscow, , Russian Federation
Manassas, Virginia, United States
Tampa, Florida, United States
Tucson, Arizona, United States
Huntington Park, California, United States
Deland, Florida, United States
Orlando, Florida, United States
Bainbridge, Georgia, United States
Biloxi, Mississippi, United States
Jefferson City, Missouri, United States
West Seneca, New York, United States
Charlotte, North Carolina, United States
Morganton, North Carolina, United States
Oklahoma City, Oklahoma, United States
Uniontown, Pennsylvania, United States
Summerville, South Carolina, United States
San Antonio, Texas, United States
Puebla, , Mexico
St Petersburg, Florida, United States
Dallas, Texas, United States
Greensboro, North Carolina, United States
Manipal, , India
Slagelse, , Denmark
Oulu, , Finland
Berlin, , Germany
Sopron, , Hungary
Nagpur, Maharashtra, India
Mexico City, Distrito Federal, Mexico
Culiacan, Sinaloa, Mexico
Queretaro, , Mexico
Cidra, , Puerto Rico
Sibiu, , Romania
Dzerzhinskiy, , Russian Federation
Szeged, , Hungary
Guadalajara, Jalisco, Mexico
Eugene, Oregon, United States
South Miami, Florida, United States
Dallas, Texas, United States
St.Petersburg, , Russian Federation
San Antonio, Texas, United States
Virginia Beach, Virginia, United States
Granby, Quebec, Canada
Durango, , Mexico
Boynton Beach, Florida, United States
Carmichael, California, United States
Chino, California, United States
Elizabeth, New Jersey, United States
Tucson, Arizona, United States
Brooksville, Florida, United States
Blue Ridge, Georgia, United States
Miami, Florida, United States
Krasnoyarsk, , Russian Federation
Mobile, Alabama, United States
Saint Petersburg, , Russian Federation
Rolling Fork, Mississippi, United States
Yukon, Oklahoma, United States
Greenville, South Carolina, United States
Houston, Texas, United States
Veracruz, , Mexico
Hialeah, Florida, United States
Greenbrae, California, United States
Santa Ana, California, United States
Denver, Colorado, United States
Atlanta, Georgia, United States
Tustin, California, United States
Lima, , Peru
Tlalpan, Distrito Federal, Mexico
Baton Rouge, Louisiana, United States
Metairie, Louisiana, United States
Jackson, Mississippi, United States
Trenton, New Jersey, United States
Los Angeles, California, United States
Las Vegas, Nevada, United States
Pasadena, Texas, United States
Clearwater, Florida, United States
Duluth, Georgia, United States
Copenhagen, , Denmark
Pirna, , Germany
Vijayawada, Andhra Pradesh, India
Chiclayo, Lambayeque, Peru
Cusco, , Peru
West Hills, California, United States
Orange, California, United States
Orlando, Florida, United States
Middleburg Heights, Ohio, United States
Santiago De Compostela, A Coruna, Spain
Indore, Madhya Pradesh, India
Houston, Texas, United States
Miami, Florida, United States
Broomall, Pennsylvania, United States
Houston, Texas, United States
Bangalore, Karnataka, India
Watertown, Massachusetts, United States
Ozark, Alabama, United States
Phoenix, Arizona, United States
Tempe, Arizona, United States
Tempe, Arizona, United States
Little Rock, Arkansas, United States
Little Rock, Arkansas, United States
Anaheim, California, United States
Anaheim, California, United States
Lomita, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Los Angeles, California, United States
Northridge, California, United States
Norwalk, California, United States
Riverside, California, United States
Sacramento, California, United States
Santa Monica, California, United States
Aurora, Colorado, United States
Chipley, Florida, United States
Doral, Florida, United States
Hialeah, Florida, United States
Miami Beach, Florida, United States
Miami Springs, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Miami, Florida, United States
Perry, Georgia, United States
Chicago, Illinois, United States
O?Fallon, Illinois, United States
Avon, Indiana, United States
Brownsburg, Indiana, United States
Franklin, Indiana, United States
Michigan City, Indiana, United States
Muncie, Indiana, United States
Silver Spring, Maryland, United States
Brookline, Massachusetts, United States
Fall River, Massachusetts, United States
New Bedford, Massachusetts, United States
Novi, Michigan, United States
Kansas City, Montana, United States
Henderson, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Nashua, New Hampshire, United States
New York, New York, United States
North Massapequa, New York, United States
Wilmington, North Carolina, United States
Fargo, North Dakota, United States
Feasterville Trevose, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Warwick, Rhode Island, United States
Anderson, South Carolina, United States
Simpsonville, South Carolina, United States
Chattanooga, Tennessee, United States
Knoxville, Tennessee, United States
Memphis, Tennessee, United States
Arlington, Texas, United States
Dallas, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
North Richland Hills, Texas, United States
Plano, Texas, United States
Sugarland, Texas, United States
Sugarland, Texas, United States
Magna, Utah, United States
Salt Lake City, Utah, United States
Arlington, Virginia, United States
Burke, Virginia, United States
Suffolk, Virginia, United States
Port Orchard, Washington, United States
Kelowona, British Columbia, Canada
Victoria, British Columbia, Canada
Brampton, Ontario, Canada
Montreal, Quebec, Canada
Medellin, Antioquia, Colombia
Bogota, Cundinamarca, Colombia
Armenia, Quindio, Colombia
Cali, Valle, Colombia
Barranquilla, , Colombia
Beroun, , Czech Republic
Cheb, , Czech Republic
Liberec, , Czech Republic
Ostrava, , Czech Republic
Prague 1, , Czech Republic
Praha 4, , Czech Republic
Frederiksberg, , Denmark
Kokkola, , Finland
Aschaffenburg, Bavaria, Germany
Vellmar, Hessen, Germany
Duisburg, Nordrhein Westfalen, Germany
Bad Kreuznach, , Germany
Karlsruhe, , Germany
Kothen, , Germany
Kronshagen, , Germany
Langenfeld, , Germany
Lueneburg, , Germany
Saarbruecken, , Germany
Gyongyos, Heves, Hungary
Hatvan, , Hungary
Miskolc, , Hungary
Nagykanizsa, , Hungary
Nyiregyhaza, , Hungary
Satoraljaujhely, , Hungary
Szekszard, , Hungary
New Delhi, Delhi, India
Belgaum, Karnatka, India
Delhi, New Delhi, India
Jaipur, Rajasthan, India
Coimbatore, Tamil Nadu, India
Madurai, Tamilnadu, India
Torreon, Coahuila, Mexico
Del. Benito Juarez, Distrito Federal, Mexico
Mexico, Df, Distrito Federal, Mexico
Cuautla, Morelos, Mexico
Chihuahua, , Mexico
Lince, Lima, Peru
Arequipa, , Peru
Ica, , Peru
Piura, , Peru
Bialystok, , Poland
Bydgoszcz, , Poland
Chrzanow, , Poland
Gdansk, , Poland
Gdynia, , Poland
Golub Dobrzyn, , Poland
Kamieniec Zabkowicki, , Poland
Katowice, , Poland
Krakow, , Poland
Lodz, , Poland
Ostroda, , Poland
Poznan, , Poland
Szczecin, , Poland
Warsaw, , Poland
Warszawa, , Poland
Wroc#Aw, , Poland
Wrocb Aw, , Poland
Zamosc, , Poland
Oradea, Bihor, Romania
Timisoara, Jud. Timis, Romania
Targu Mures, Mures, Romania
Ploiesti, Prahova, Romania
Bucuresti, , Romania
Satu Mare, , Romania
Novosibirsk, , Russian Federation
St. Petersburg, , Russian Federation
La Roca Del Valles, , Spain
Peralada, , Spain
Patients applied
Trial Officials
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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