NCT02750007Unknown1 期
Open-label, Non-randomized, Weekly-dose Titration Study to Assess the Tolerability to HS-20004 in Type 2 (Diabetes Mellitus) Diabetic Patients
Jiangsu Hansoh Pharmaceutical Co., Ltd.1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年12月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Number of Treatment Emergent Adverse Events(TEAEs)
研究概览
简要总结
This study is conducted in China. The aim of this trial is to assess the tolerability to HS-20004 with titration administration in type 2 diabetic patients.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Type 2 diabetes diagnosed for more than 3 months;
- •HbA1c between ≥6.0 and ≤9.0 %, and FPG between ≥7.0 and ≤13.9 mmol/L;
- •Body Mass Index (BMI) between 18.5 and 30 kg/m^2 (inclusive) with a total body weight of at least 50 kg;
- •Agree to stop any other drugs for diabetes during washout and study period;
排除标准
- •Treatment of GLP-1 analogues, DPP-IV enzyme inhibitors or other analogues before;
- •History or family history of drug allergy;
- •Smoker or alcohol abuse;
- •Currently use or plan to use systemic corticosteroid;
- •History of recurrent severe hypoglycemia;
- •History of proliferative retinopathy or maculopathy which required acute treatment;
- •Impaired hepatic or renal function, or cardiac problem;
- •Uncontrolled active or untreated hypertension;
- •Family history of thyroid cancer or submandibular gland cancer, or past history of pancreatitis, cholelithiasis, or serious unconscious hypoglycemia history;
- •Positive of hepatitis B surface antigen, hepatitis C antibody, HIV antibody or syphilis antibody;
- •Subject has participated in any investigational study within 3 months, or is currently participating in another clinical study;
- •Female subject of childbearing potential who does not use an acceptable method of birth control, is pregnant or planning a pregnancy, or breastfeeding, or male subject who does not use an acceptable method of birth control, within six months before randomization; Subject who cannot refrain from smoking, eating and/or drinking containing xanthine/caffeine, or strenuous exercise, or others that affect drug absorption, distribution, metabolism and excretion within 2 days before the study drug administration;
- •Have any other medical abnormality (such as cardiovascular, hepatic, renal, gastrointestinal, immunologic, hematological, hormonal, metabolic, neoplasmatic or mental disease), which in the opinion of the investigator, might affect the absorption, distribution, metabolism, and excretion of the study drug, or prevent the patient from following and completing the protocol；
- •Subject was not used for the study as determined by the Investigator.
研究组 & 干预措施
Experimental
Experimental
Weekly-dose titration from 0.04mg/day HS-20004 to the maximum tolerable dose or of the ultimate 0.18mg/day
干预措施: HS-20004 (Drug)
结局指标
主要结局
Number of Treatment Emergent Adverse Events(TEAEs)
时间窗: through study completion, an maximum of 8 weeks
次要结局
- Number of Nausea and vomiting during titration(through study completion, an maximum of 8 weeks)
- Change in plasma concentration of glucose from baseline at different dose steps(through study completion, an maximum of 8 weeks)
- Change in plasma concentration of insulin from baseline at different dose steps(through study completion, an maximum of 8 weeks)
- Change in plasma concentration of glucagon from baseline at different dose steps(through study completion, an maximum of 8 weeks)
- The minimum dose of HS-20004 that could keep plasma glucose under 6.1 mmol/L in Type 2 Diabetic Patients(through study completion, an maximum of 8 weeks)
- Mean Change From Baseline in Body Weight at different dose steps(through study completion, an maximum of 8 weeks)
- Change in plasma concentration of HS-20004 from baseline at different dose steps(through study completion, an maximum of 8 weeks)
研究者
研究点 (1)
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