NCT02685345已完成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
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 85
- 主要终点
- change in 24 hour weighted mean glucose
研究概览
简要总结
The objectives of the study is to evaluate the efficacy and safety of DS-8500a compared with placebo in patients with type 2 diabetes mellitus (T2DM) receiving sitagliptin.
详细描述
In patients with type 2 diabetes mellitus being treated with sitagliptin, efficacy and safety of DS-8500a are to be evaluated after 28-day multiple oral administration of DS-8500a at 25 or 75 mg, in a double-blind, placebo-controlled, parallel-group comparison study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Japanese patients with type 2 diabetes
- •Patients aged ≥ 20 years at the time of informed consent
- •Patients who have been treated with sitagliptin 50 mg monotherapy for the treatment of type 2 diabetes mellitus
- •Patients who have HbA1c ≥ 7.0% and < 9.0%
排除标准
- •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/dL
研究组 & 干预措施
DS-8500a 25 mg QD
Experimental
DS-8500a 25 mg tablets, orally, once daily (QD) for up to 28 days
干预措施: DS-8500a 25 mg (Drug)
DS-8500a 75 mg QD
Experimental
DS-8500a 75 mg tablets, orally, once daily (QD) for up to 28 days
干预措施: DS-8500a 75 mg (Drug)
placebo
Placebo Comparator
placebo tablets, orally, once daily for up to 28 days
干预措施: placebo (Drug)
结局指标
主要结局
change in 24 hour weighted mean glucose
时间窗: baseline (Day -1) to Day 28
次要结局
- change in glycoalbumin(baseline (Day -1) and Day 28)
- change in fasting plasma glucose(baseline (Day -1) to Day 28)
- change in serum insulin(baseline (Day -1) and Day 28)
- change in derived glucagon AUC(baseline (Day -1) to after dosing on Day 28)
- change in PYY (pancreatic peptide YY3-36)(baseline (Day -1) and Day 28)
- change in total GLP-1 (Glucagon-like peptide-1)(baseline (Day -1) and Day 28)
- change in total total cholesterol(baseline (Day -1) to after dosing on Day 28)
- change in total LDL (low density lipoprotein) cholesterol(baseline (Day -1) to after dosing on Day 28)
- change in total HDL (high density lipoprotein) cholesterol(baseline (Day -1) to after dosing on Day 28)
- change in plasma glucose(baseline (Day -1) and Day 28)
- change in proinsulin(baseline (Day -1) and Day 28)
- change in total GIP (Gastric inhibitory polypeptide)(baseline (Day -1) and Day 28)
- change in total triglyceride(baseline (Day -1) to after dosing on Day 28)
- change in derived PYY AUC(baseline (Day -1) to after dosing on Day 28)
- change in C-peptide(baseline (Day -1) and Day 28)
- number and severity of adverse events(baseline (Day -1) to after dosing on Day 28)
- change in derived total GIP AUC(baseline (Day -1) to after dosing on Day 28)
- change in active GLP-1 (Glucagon-like peptide-1)(baseline (Day -1) and Day 28)
- change in total glucagon(baseline (Day -1) and Day 28)
- change in derived plasma glucose AUC(baseline (Day -1) to after dosing on Day 28)
- change in derived serum insulin AUC(baseline (Day -1) to after dosing on Day 28)
- change in derived C-peptide AUC(baseline (Day -1) to after dosing on Day 28)
- change in derived total GLP-1 AUC(baseline (Day -1) to after dosing on Day 28)
- change in derived active GLP-1 AUC(baseline (Day -1) to after dosing on Day 28)
研究者
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