Phase III Long-Term Clinical Study of CSG452(RG7201) in Patients with Type 2 Diabetes. -Long-term Study in Combination Therapy

Chugai Pharmaceutical Co., Ltd.0 个研究点目标入组 565 人开始时间: 2010年11月17日最近更新: 2023年10月17日

适应症

试验速览

暂无简介。

•Has been diagnosed with type 2 diabetes
•-Has been receiving treatment with one of oral hypoglycaemic drugs at an approved dosing regimen in addition to diet and exercise therapy, and there has been no change in the prescription
•-HbA1c (Japanese Diabetes Society [JDS] value) >=6.5% and <10.0%
•-Body mass index (BMI) >=18.5 kg/m2 and <45.0 kg/m2

•Had the following history and/or complications within 24 weeks of tests for screening test
•-Acute diabetic complications such as diabetic ketoacidosis or hyperglycemic hyperosmolar coma
•-Acute coronary disease (acute myocardial infarction, unstable angina, etc.) or stroke
•-Recurrent genitourinary tract infection, defined as two or more episodes of complicated or uncomplicated cystitis or pyelonephritis
•-Impaired hepatic function
•-Impaired renal function

发起方