A Phase III Study of BMS-512148 (Dapagliflozin) in Asian Patients With Type 2 Diabetes Who Are Not Well Controlled on Metformin Alone
Launched by ASTRAZENECA · Mar 26, 2010
Trial Information
Current as of May 30, 2025
Completed
Keywords
ClinConnect Summary
No description provided
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Males and females, 18 to 77 years old, with type 2 diabetes and with inadequate glycemic control
- • Drug naive or treated with anti-diabetic medication for \< 24 weeks
- • C-peptide ≥ 1.0 ng/mL
- • Body Mass Index ≤ 45.0 kg/m²
- Exclusion Criteria:
- • AST and/or ALT \> 3 times ULN
- • Serum total bilirubin \> 2 mg/dL
- • Serum creatinine ≥ 1.50 mg/dL for men or ≥ 1.40 mg/dL for women
- • Creatine kinase ≥ 3 times ULN
- • Symptoms of severely uncontrolled diabetes
- • 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
Vellore, Tamilnadu, , India
Hefei, Anhui, China
Hangzhou, Zhejiang, China
Busan, , Korea, Republic Of
Guangzhou, Guangdong, China
Haerbin, Heilongjiang, China
Changsha, Hunan, China
Shenyang, Liaoning, China
Shanghai, Shanghai, China
Beijing, Beijing, China
Nanjing, Jiangsu, China
Changchun, Jilin, China
Indore, Madhya Pradesh, India
Chongqing, Chongqing, China
Wuxi, Jiangsu, China
Chengdu, Sichuan, China
Tianjin, Tianjin, China
Bangalore, Karnataka, India
Jaipur, , India
Seoul, Nowon Gu, Korea, Republic Of
Xi'an, , China
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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