NCT03848793已完成2 期
A Phase 2, Multiple Centers, Double-blind, Placebo-Controlled, Randomised Study to Evaluate the Efficacy and Safety of HS-20004 in Type 2 Diabetes Subjects.
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
- 128
- 试验地点
- 1
- 主要终点
- HbA1c
研究概览
简要总结
The study is being conducted to evaluate the efficacy and safety of Noiiglutide Injection as mono-therapy with different doses in subjects with type 2 diabetes compared to placebo for 16 weeks.
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
- 18 Years 至 70 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 7.5 and 11.0 % (inclusive), and FPG ≥9.0mmol/l
- •Body Mass Index (BMI) between 23 and 35 kg/m2(inclusive)
- •Exclusion Criteria：
- •History or family history of drug allergy
- •Subjects treated with any other anti-diabetes drug within 8 weeks before screening
- •Participation in any other clinical trial of an investigational medicinal product within 3 months before screening
- •Smoker or alcohol abuse
- •Currently use or plan to use systemic corticosteroid
- •History of recurrent severe hypoglycemia
- •Type 1 diabetes or secondary diabetes mellitus
- •Uncontrolled active or untreated hypertension
- •History of pancreatitis (acute or chronic)
- •Family or personal history of Multiple Endocrine Neoplasia Type 2 (MEN2) or Medullary Thyroid Carcinoma (MTC)
- •Serious unconscious hypoglycemia history
- •Within the past 6 months before screening any of the following: coronary artery revascularization, patients presently classified as being in New York Heart Association (NYHA) Class III or IV, myocardial infarction, stroke or unstable angina and/or persistent and clinically significant arrhythmias
- •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
- •Subject was not used for the study as determined by the Investigator
排除标准
- 未提供
研究组 & 干预措施
HS-20004 or placebo treatment (Low dose)
Other
HS-20004 or placebo SC once daily (Low dose)
干预措施: HS-20004 (Drug)
HS-20004 or placebo treatment (median dose 1)
Other
HS-20004 or placebo SC once daily (median dose 1)
干预措施: HS-20004 (Drug)
HS-20004 or placebo treatment (median dose 2)
Other
HS-20004 or placebo SC once daily (median dose 2)
干预措施: HS-20004 (Drug)
HS-20004 or placebo treatment (high dose)
Other
HS-20004 or placebo SC once daily (high dose)
干预措施: HS-20004 (Drug)
结局指标
主要结局
HbA1c
时间窗: 16 weeks treatment
Estimated mean change from baseline in HbA1c at week 16. The data were analysed for the "on-treatment until rescue medication" observation period which includes observations recorded at or after date of first dose of trial product
次要结局
- Change in Fasting Plasma Glucose(16 weeks treatment)
- Change in Body Weight(16 weeks treatment)
研究者
研究点 (1)
Loading locations...
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