JPRN-jRCT2080221315未知3 期
Phase III Long-Term Clinical Study of CSG452(RG7201) in Patients with Type 2 Diabetes. -Long-term Study in Combination Therapy
适应症
试验速览
- 阶段
- 3 期
- 入组人数
- 565
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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