Safety and Efficacy of Dapagliflozin as Monotherapy in Subjects With Type 2 Diabetes
Launched by ASTRAZENECA · Aug 15, 2008
Trial Information
Current as of June 25, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Male and females, ≥18 to ≤77 years old, with type 2 diabetes mellitus
- • Subjects must have central laboratory pre-randomization A1C ≥7.0 and ≤ 10.0%
- • C-peptide ≥ 1.0 ng/mL (0.34 nmol/L)
- • Body Mass Index ≤ 45 kg/m²
- • Must be able to perform self monitoring of blood glucose
- Exclusion Criteria:
- • aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3\* upper limit of normal (ULN)
- • Serum Total bilirubin \>2 mg/dL (34.2 µmol/L)
- • Creatinine kinase \>3\* ULN
- • Serum creatinine ≥1.50 mg/dL (133 µmol/L) for male subjects, ≥1.40 mg/dL (124 µmol/L) for female subjects
- • Currently unstable or serious cardiovascular, renal, hepatic, hematological, oncological, endocrine, psychiatric, or rheumatic diseases
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
Fresno, California, United States
Smolensk, , Russian Federation
Taylors, South Carolina, United States
Ponce, , Puerto Rico
St.Petersburg, , Russian Federation
Tustin, California, United States
Paarl, Western Cape, South Africa
New London, Connecticut, United States
Marianna, Florida, United States
Roswell, Georgia, United States
St Leonard, Quebec, Canada
Df, Distrito Federal, Mexico
Guadalajara, Jalisco, Mexico
Monterrey, Nuevo Leon, Mexico
Tygerberg, Western Cape, South Africa
San Antonio, Texas, United States
Merida, Yucatan, Mexico
Kursk, , Russian Federation
St. Petersburg, , Russian Federation
Phoenix, Arizona, United States
Jacksonville, Florida, United States
West Seneca, New York, United States
Winnipeg, Manitoba, Canada
Bathurst, New Brunswick, Canada
Toronto, Ontario, Canada
Drummondville, Quebec, Canada
Jaipur, , India
Salt Lake City, Utah, United States
L'ancienne Lorette, Quebec, Canada
Durango, , Mexico
Saint Petersburg, , Russian Federation
Altamonte Springs, Florida, United States
Litchfield Park, Arizona, United States
Tempe, Arizona, United States
Saratov, , Russian Federation
Veracruz, , Mexico
Olympia, Washington, United States
Midvale, Utah, United States
Lomita, California, United States
Los Gatos, California, United States
Greeley, Colorado, United States
Belzoni, Mississippi, United States
Hamilton, New Jersey, United States
Syracuse, New York, United States
Morehead City, North Carolina, United States
Akron, Ohio, United States
Oklahoma, Oklahoma, United States
Spokane, Washington, United States
Calgary, Alberta, Canada
Coquitlam, British Columbia, Canada
Ajax, Ontario, Canada
Waterloo, Ontario, Canada
Ahmedabad, , India
Bangalore, , India
Mexico City, , Mexico
Benoni, Gauteng, South Africa
Soweto, Gauteng, South Africa
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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