A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Type 2 Diabetic Patients
Launched by ASTELLAS PHARMA INC · Jun 1, 2010
Trial Information
Current as of September 06, 2025
Completed
Keywords
ClinConnect Summary
This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in combination with metformin in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with metformin alone. The effects of ASP1941 are compared with those of placebo.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Type 2 diabetic patients receiving with metformin mono-therapy for at least 6 weeks
- • HbA1c value between 7.0 and 9.5%
- • Body Mass Index (BMI) 20.0 - 45.0 kg/m2
- Exclusion Criteria:
- • Type 1 diabetes mellitus patients
- • Serum creatinine \> upper limit of normal
- • Estimated GFR \< 60ml/min/1.73m2
- • Proteinuria (albumin/creatinine ratio \> 300mg/g)
- • Dysuria and/or urinary tract infection, genital infection
- • Significant renal, hepatic or cardiovascular diseases
- • Severe gastrointestinal diseases
About Astellas Pharma Inc
Astellas Pharma Inc. is a global pharmaceutical company dedicated to improving the health of patients through innovative research and development. With a strong focus on urology, oncology, immunology, and neuroscience, Astellas is committed to advancing medical science and delivering transformative therapies. The company operates with a patient-centric approach, striving to address unmet medical needs while adhering to the highest standards of ethics and compliance in clinical trials. Astellas leverages cutting-edge technology and collaborates with healthcare professionals and institutions worldwide to bring forward new treatment options that enhance the quality of life for patients.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hokkaido, , Japan
Chubu, , Japan
Chugoku, , Japan
Kansai, , Japan
Kyushu, , Japan
Touhoku, , Japan
Kantou, , Japan
Patients applied
Trial Officials
Use Central Contact
Study Chair
Astellas Pharma Inc
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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