NCT02537834已完成4 期
An Open-Label, Multicenter Study to Evaluate 52-Week Long-Term Safety, Tolerability and Efficacy of Tofogliflozin With Glucagon-like Peptide-1(GLP-1) Analogue Treatment In Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 65
- 主要终点
- Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction
研究概览
简要总结
An open-label, multicenter study to evaluate 52-week long-term safety, tolerability and efficacy of Tofogliflozin with GLP-1 analogue treatment in type 2 diabetes mellitus.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The subject aged from 20 to 75 years old with type 2 diabetes mellitus(T2DM)
- •The subject with hemoglobin A1c ≧7.5% - <10.5 %
- •The subject who has been receiving a stable dose and regimen of GLP-1 analogue over 8 weeks before Screening test
排除标准
- •The subject with type 1 diabetes mellitus
- •The subject with Pregnancy or lactation
- •The subject with Fasting Plasma Glucose ≧ 270 mg/dl
- •The subject with history of metabolic acidosis, including diabetic ketoacidosis ,within 1 year prior to screening
- •The subject with myocardial infarction, stroke, or heart failure requiring hospitalization or drug or alcohol abuse within the previous 6 months
- •The subject with serum creatinine level greater than 2.0 mg/dL for men and 1.5 mg/dL for women
- •The subject with aspartate aminotransferase(AST) or alanine aminotransferase(ALT) ≧ 2.5 times the upper limit of the reference range at the central laboratory test facility
- •The subject has received treatment with another investigational product or non-approved drug 3 months before screening
- •The subject with history of Tofogliflozin therapy
- •The subject with estimated glomerular filtration rate of <30 mL/min/1.73 m^2
- •The subject who frequently experiencing orthostatic hypotension
- •The subject systolic blood pressure of ≧ 180 or mmHg of diastolic blood pressure of ≧ 100 mmHg
- •The subject required a change in the dosing regiment for the following drugs within 4 weeks before screening : Lipid-lowering drug , Antihypertensive drug, Thyroid hormone drug , Uric acid lowering drug
研究组 & 干预措施
Tofogliflozin ＋GLP-1 analogue
Experimental
Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.
干预措施: Tofogliflozin (Drug)
Tofogliflozin ＋GLP-1 analogue
Experimental
Tofogliflozin administered once daily for 52 weeks. GLP-1 analogue administered as base treatment.
干预措施: GLP-1 analogue (Drug)
结局指标
主要结局
Safety and Tolerability Assessed by Adverse Event and Adverse Drug Reaction
时间窗: baseline and Week 52
Change from Baseline in HbA1c at 52 weeks
时间窗: Week 52
次要结局
- Change in Fasting plasma glucose(baseline and week 52)
- Change in Blood pressure(baseline and week 52)
- Change in Uric Acid(baseline and week 52)
- Change in LDL-C(baseline and week 52)
- Change in Total cholesterol(baseline and week 52)
- Change in non HDL-C(baseline and week 52)
- Change in Free Fatty Acid(baseline and week 52)
- Change in Body Weight(baseline and week 52)
- Change in HDL-C(baseline and week 52)
研究者
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