NCT06256523已完成1 期
A Multicenter, Randomized, Double-blind, Placebo-controlled Phase Ib/IIa Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GZR18 Injection in Chinese Adult Patients With Type 2 Diabetes Mellitus (T2DM)
Gan and Lee Pharmaceuticals, USA1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2022年6月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Changes from baseline in hemoglobin A1c (HbA1c) at the end of the study
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled Phase Ib/IIa clinical study in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise and/or treated with irregular use of antidiabetic drugs to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in adult subjects with T2DM. This study is divided into Part A and Part B, which are to be conducted simultaneously.
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
- Double (Participant, Investigator)
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
- •Chinese adults, male and female, aged 18-65 years (both inclusive; subject to the date of signing of ICF).
- •Diagnosis of type 2 diabetes mellitus according to the diagnostic and classification criteria for diabetes mellitus issued by the World Health Organization (WHO) in
- •Patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise and/or treated with irregular use of antidiabetic drugs.
- •Hemoglobin A1c (HbA1c) ≥ 7.0% and ≤ 10 % at screening;
- •Body mass index (BMI) ≥ 18.5 kg/m2 and ≤ 35 kg/m2 at screening.
- •Those who have no birth and sperm donation plans, and voluntarily take effective contraceptive measures from the signing of ICF to 3 months after the last dose. A negative pregnancy test for women of childbearing potential at screening.
- •Fully understanding the study objectives, the nature of the study, methods used and adverse reactions that may occur in the study, willing to enter the study and sign the ICF, and capable of communicating well with the investigator, and understanding and abiding by the requirements of the study.
排除标准
- •Diabetes mellitus other than T2DM, such as type 1 diabetes mellitus.
- •Fasting C-peptide < 0.3 nmol/L.
- •Use of any DPP-4 inhibitors, insulin secretagogues such as sulfonylureas, TZDs and/or GLP-1 analogs within 3 months prior to screening.
- •Continuous insulin use for more than 14 days within 1 year prior to screening (time of insulin use for gestational diabetes mellitus is excluded from this limit).
- •Treatment with growth hormone, diuretics, etc., that may affect insulin levels as judged by the investigator within 6 months prior to screening.
- •Immunoserologic panel test results [infection screening tests for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV-Ab), human immunodeficiency virus antibody (HIV-Ab), and Treponema pallidum antibody] assessed by the investigator as abnormal and clinically significant.
研究组 & 干预措施
GZR18
Experimental
GZR18 injection s.c.
干预措施: GZR18 (Drug)
Placebo
Placebo Comparator
Placebo injection s.c.
干预措施: Placebo (Other)
结局指标
主要结局
Changes from baseline in hemoglobin A1c (HbA1c) at the end of the study
时间窗: 26 weeks
Number of adverse events and serious adverse events
时间窗: 29 weeks
次要结局
- Trough concentrations of GZR18 following consecutive doses(26 weeks)
- HbA1c control rate (proportions of subjects with HbA1c < 6.5 % and HbA1c < 7.0 %)(26 weeks)
研究者
研究点 (1)
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