NCT06256549进行中（未招募）2 期
A Multicenter, Randomized, Controlled Phase II Clinical Trial to Evaluate the Efficacy and Safety of GZR18 Injection in Chinese Patients With Type 2 Diabetes Mellitus
Gan and Lee Pharmaceuticals, USA1 个研究点 分布在 1 个国家目标入组 272 人开始时间: 2023年8月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 272
- 试验地点
- 1
- 主要终点
- Compared with Semaglutide, the changes of HbA1c compared with baseline after continuous administration of GZR18 injection for 24 weeks
研究概览
简要总结
This study was a multicenter, randomized, parallel and controlled study in adult patients with T2DM to evaluate the efficacy, safety (including immunogenicity) and pharmacokinetics of GZR18 injection in adult patients with T2DM.
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
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(1) Chinese adults, male or female aged between 18 and 75 (including both ends).
- •(2) According to the diagnostic and classification criteria of diabetes issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria of WHO in 2011, type 2 diabetes was diagnosed for more than 3 months.
- •(3) Lifestyle intervention and / or unregulated use of antidiabetic drugs within 3 months before screening, or stable use of less than 3 oral hypoglycemic drugs within 3 months before screening.
- •(4) HbA1c (HbA1c) ≥ 7.0% and ≤ 11% during screening.
- •(5) Body mass index (BMI) ≥ 18.5 kg/m
- •(6) There is no birth plan within 6 months from the signing of informed consent to the last administration, and those who voluntarily take effective contraceptive measures and have no sperm donation plan. Fertile women are not breastfeeding, and the screening and baseline pregnancy tests must be negative.
- •(7) Patients fully understand the purpose, nature, methods and possible adverse reactions of the trial, can communicate well with researchers, and can understand and comply with the requirements of this study. During the study, they can maintain a stable diet and exercise lifestyle, and voluntarily sign an informed consent form to enter this study.
排除标准
- •(1) Known or suspected to be allergic to GLP-1 drugs or their excipients, or have contraindications to their use.
- •(2) Those who participated in clinical trials of other drugs or devices within 3 months before were screened and given treatment.
- •(3) Surgery that can lead to weight instability was performed within 2 months before screening, or non-diabetic drugs that affect weight are currently being used or are in the weight loss program and are not in the maintenance stage.
- •(4) History of alcohol or drug abuse, or positive results of pre-random drug abuse screening (urine screening).
- •(5) Continuous use of insulin for more than 14 days in one year before screening (the time for gestational diabetes to receive insulin treatment is not within this limit); GLP-1RA drugs were used in the first 6 months; dipeptidyl peptidase-4 (DPP-4) inhibitors were used in the first month.
- •(6) Growth hormone and other drug treatments determined by researchers to affect insulin levels were performed within 3 months before screening.
- •(7) Diabetic ketoacidosis, diabetic lactic acidosis or hyperosmotic nonketotic diabetic coma within 6 months before screening.
研究组 & 干预措施
GZR18
Experimental
GZR18 injection s.c.
干预措施: GZR18 (Drug)
Semaglutide
Active Comparator
Semaglutide injection s.c.
干预措施: Semaglutide (Drug)
结局指标
主要结局
Compared with Semaglutide, the changes of HbA1c compared with baseline after continuous administration of GZR18 injection for 24 weeks
时间窗: 24 weeks
次要结局
- HbA1c compliance rate (< 7.0% and ≤ 6.5% of patients)(24 weeks)
- The overall incidence of adverse events and the incidence of serious adverse events(27 weeks)
研究者
研究点 (1)
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