JPRN-jRCT2080223082未知2 期
A phase 2, randomized, double-blind, placebo-controlled, add-on study of DS-8500a in Japanese patients with type 2 diabetes mellitus receiving sitagliptin
适应症
试验速览
- 阶段
- 2 期
- 入组人数
- 90
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
- •Main Inclusion Criteria;
- •1)Japanese patients with type 2 diabetes mellitus
- •2)Patients aged >= 20 years
- •3)Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus
- •4)Patients who have >= 7.0% and < 9.0% HbA1c
排除标准
- •Main Exclusion Criteria;
- •-Patients with type 1 diabetes mellitus or with a history of diabetic coma, precoma, or ketoacidosis
- •-Patients receiving or requiring treatment with insulin
- •-Patients with a body mass index (BMI) of < 18.5 kg/m2 or >= 35.0 kg/m2
- •-Patients with clinically evident renal impairment (estimated glomerular filtration rate [eGFR] of < 45 mL/min per 1.73 m2) or clinically significant renal disease
- •-Patients with fasting plasma glucose >= 240 mg/d
研究者
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