NCT07387003尚未招募2 期
A Multicenter Phase 2 Clinical Study to Evaluate the Efficacy and Safety of GZR101-80 Injection in Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Oral Antidiabetic Drugs or Patients With Type 2 Diabetes Mellitus Inadequately Controlled on Basal Insulin
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 345
- 试验地点
- 1
- 主要终点
- Change in Hemoglobin A1c (HbA1c) from baseline after 16 weeks of treatment.
研究概览
简要总结
This study will be conducted to evaluate the efficacy and safety of GZR101-80 Injection in patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs or Basal Insulin.
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
- •Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and are able to follow the contraindications and restrictions specified in this protocol.
- •At the age of 18-75 (inclusive) at the time of informed consent, male or female.
- •Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at screening.
- •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.
排除标准
- •Confirmed or suspected type 1 diabetes mellitus or specific types of diabetes due to other causes (monogenic diabetes, cystic fibrosis, pancreatitis, drug- or chemical-induced diabetes, etc.) prior to screening.
- •Grade 3 hypoglycemia within 3 months before screening.
- •Subjects who have any diseases that may affect HbA1c testing at screening, or subjects who have donated blood, lost more than 400 mL of blood, or received blood transfusion within 3 months prior to screening.
- •Diagnosis of active malignant tumor within 5 years prior to screening (excluding adequately treated or resected non-metastatic basal or squamous cell skin cancer, in situ cancer of cervix, or prostate cancer in situ), or with a high suspicion of potential malignant tumor at screening.
研究组 & 干预措施
GZR101-80
Experimental
干预措施: GZR101-80 (Drug)
GZR33 or Insulin degludec/Insulin aspart or Insulin aspart 30 (NovoRapid®30)
Active Comparator
干预措施: GZR33 or Insulin degludec/Insulin aspart or Insulin aspart30 (NovoRapid®30) (Drug)
结局指标
主要结局
Change in Hemoglobin A1c (HbA1c) from baseline after 16 weeks of treatment.
时间窗: Baseline , 16 weeks
次要结局
- Change in fasting plasma glucose (FPG) from baseline after 16 weeks of treatment(Baseline , 16 weeks)
- Safety Endpoints(Baseline , 17 weeks)
研究者
研究点 (1)
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