NCT06202079已完成2 期
A Phase 2 Clinical Trial Comparing the Efficacy and Safety of Once-weekly GZR4 Injection Versus Once-daily Insulin Degludec in Subjects with Type 2 Diabetes Mellitus on OAD Therapy or OAD Therapy in Combination with Basal Insulin
Gan and Lee Pharmaceuticals, USA8 个研究点 分布在 1 个国家目标入组 179 人开始时间: 2023年8月11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
- 已完成
- 发起方
- 入组人数
- 179
- 试验地点
- 8
- 主要终点
- Change in HbA1c
研究概览
简要总结
This study compares the efficacy, safety, and tolerability of once-weekly GZR4 Injection versus once-daily insulin degludec in patients with type 2 diabetes mellitus in inadquete control on oral antidiabetic drug (OAD) therapy or OAD Therapy in combination with 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
- •Aged 18-75 years (both inclusive) at the time of signing informed consent form (ICF)
- •Body mass index between 18.5 and 35.0 kg/m2 (both inclusive)
- •Diagnosed with type 2 diabetes mellitus above or equal to 6 months
- •7.5% ≤ HbA1c ≤ 10.0% at screening.
排除标准
- •Female who is pregnant, breast-feeding.
- •Presence or history of malignant neoplasm prior to screening.
- •Diabetic ketoacidosis, diabetic lactic acidosis, or diabetic nonketotic hyperosmolar syndrome within 6 months prior to screening.
- •Known or suspected hypersensitivity to investigational medical product(s) or related products.
- •Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening
- •History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening.
- •Participation in a clinical study of another study drug within 3 month prior to randomization.
研究组 & 干预措施
GZR4 Injection
Experimental
GZR4 Injection + Oral Antidiabetic Drug
干预措施: GZR4 Injection (Drug)
Insulin Degludec
Active Comparator
Insulin Degludec + Oral Antidiabetic Drug
干预措施: Insulin Degludec (Drug)
结局指标
主要结局
Change in HbA1c
时间窗: From baseline (week 0) to week 16
Change from baseline in HbA1c after 16 weeks of treatment
次要结局
- Weekly doses of GZR4 Injection/Insulin Degludec(Week 15-16)
- Incidence and Rate of Treatment-emergent adverse events (TEAEs)(From baseline (week 0) to week 20)
- Change in ADA of GZR4(From baseline (week 0) to week 16)
- Change in Nab of GZR4(From baseline (week 0) to week 16)
- Change in fasting plasma glucose(FPG)(From baseline (week 0) to week 16)
- Incidence and Rate of hypoglycemia episodes(From baseline (week 0) to week 20)
研究者
研究点 (8)
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