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 ASP 1941 in Subjects with Type 2 Diabetes Mellitus.

Astellas Pharma Inc0 个研究点目标入组 378 人开始时间: 待定最近更新: 2021年11月24日

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•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

•- 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 >110 mmHg
•- 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 H1V1 and/or HIV2
•- Subject has a history of lactic acidosis
•- Subject has a history of drug and alcohol abuse/dependency within last lst 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 medicalor psychiatric illness

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