NCT07055386进行中（未招募）2 期
A Phase II Clinical Study to Compare the Efficacy and Safety of Once-Weekly GZR102 Injection and Bi-weekly GZR18 Injection in Type 2 Diabetes Mellitus With Inadequate Glycemic Control on GLP-1 Receptor Agonists, With or Without Oral Antidiabetic Drugs
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- efficiency endpoint
研究概览
简要总结
This is a multicenter, randomized, open-label, positive controlled efficacy exploration study. To compare the efficacy and safety of once-weekly GZR102 Injection and Bi-Weekly GZR18 Injection in Chinese adult subjects with type 2 diabetes mellitus (T2DM) and inadequate glycemic control on GLP-1 receptor agonists (GLP-1RAs), with or without oral antidiabetic drugs (OADs).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •1. Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and be able to follow the contraindications and restrictions specified in this protocol.
- •2. Males or females aged ≥ 18 years at the time of signing the Informed Consent Form (ICF).
- •3. No birth plan from the signing of ICF to 8 weeks after the last dose, willingness to use effective methods of contraception, and no plan for sperm donation. Females of childbearing potential must not be lactating and must have negative results of blood pregnancy tests at screening and predose.
- •4. According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria recommended by WHO for diagnosis with Hemoglobin A1c (HbA1c) (2011), the time to diagnose T2DM is ≥ 180 days at screening.
- •5. No Insulin treatment within one year before the screening.
- •Subjects who have been on a stable dose of GLP-1RA therapy for diabetes mellitus as per the package insert for ≥ 90 days before screening, with or without antidiabetic drugs.
排除标准
- •1. Subjects with a history of drug abuse before screening or a history of alcohol abuse within 6 months before screening.
- •2. Subjects with a history of allergy to ≥ 2 drugs, or known or suspected hypersensitivity or intolerance to the IMP or similar products and their excipients.
- •3. Subjects who have taken any concomitant medication, that is known to affect weight or glucose metabolism for more than 14 consecutive days within the 90 days before screening, or who require long-term use during the study.
- •4. Participation in a clinical study of another IMP, surgery, or device within 90 days before screening.
- •5. Severe chronic complications of diabetes at the time of screening.
- •Diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar non-ketotic diabetic coma in the 90 days prior to screening.
- •7. Grade 3 hypoglycemic events within 1 year prior to screening.
- •Subjects with significant hematological disorders in screening; or subjects who have donated bloods (> 400 mL), experienced significant blood loss (> 400 mL) or received a transfusion within 90 days before screening.
- •9. Subjects with a history of (acute or chronic) pancreatitis in or before screening.
- •10. Subjects with a history of malignant tumors within 5 years before screening or the presence of potential malignant tumors in screening.
- •11. Subjects with a personal history or first-degree family history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma.
- •12. Subjects with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg during screening.
- •History of renal transplant or current renal replacement therapy.
- •Expect significant changes in diet, exercise, working circadian rhythm and other lifestyles during the study that may affect glycemia control, or unwilling to comply with relevant lifestyle restrictions during the study.
- •15. Subjects who are unable to comply with the requirements of this protocol as judged by the investigator, or have any other conditions that the investigator considers inappropriate to participate in this study
研究组 & 干预措施
GZR102
Experimental
participants will receive GZR102 subcutaneously
干预措施: GZR102 (Drug)
GZR18
Experimental
participants will receive GZR102 subcutaneously
干预措施: GZR18 (Drug)
结局指标
主要结局
efficiency endpoint
时间窗: Week 24
Change from baseline in Hemoglobin A1c (HbA1c)%
次要结局
- efficiency endpoint(Week 24)
- hypoglycemic events.(Week 24)
研究者
研究点 (1)
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