NCT06716216招募中3 期
A Phase 3, Randomized, Open-Label Trial Comparing Efficacy and Safety of BGM0504 Versus Semaglutide Once Weekly As Add-on Therapy to Metformin And/or Sulfonylureas in Patients with Type 2 Diabetes
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 537
- 试验地点
- 1
- 主要终点
- Change From Baseline in Hemoglobin A1c (HbA1c)
研究概览
简要总结
This trial is conducted in China. The aim of the trial is to evaluate the efficacy and safety of BGM0504 versus semaglutide as add-on to metformin and/or sulfonylureas in patients with type 2 diabetes
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
- •■ Have been diagnosed with type 2 diabetes mellitus (T2DM);
- •Metformin is used in screening : 1) After used stable-dose metformin (≥1500 mg/day) or maximum tolerated (< 1500mg but≥1000mg daily) for 8 weeks before screening； 2)Metformin treatment dose <1500mg/day at Screening and have not reached the maximum tolerated dose ；3) Metformin combined with daily fixed-dose sulfonylureas (minimum therapeutic dose on the drug label) had been stable for ≥8 weeks when entering the induction period.
- •Have a BMI ≥23 kilograms per meter squared (kg/m²) at screening;
- •Be of stable weight (± 5%) for at least 3 months before screening;
- •Have HbA1c between ≥7.5% and ≤11.0%；
排除标准
- •■ Previous diagnosis of type 1 diabetes, special type diabetes;
- •There are malignant tumors within 5 years before screening, or patients are in latent of clinical malignant tumors (except patients with skin basal cell carcinoma and squamous cell carcinoma, cervical carcinoma in situ, prostate carcinoma in situ or papillary thyroid carcinoma who have no recurrence after surgery).
- •Have had chronic or acute pancreatitis any time prior to study entry;
- •Known allergic constitution (allergy to 3 or more kinds of food or drugs), or allergy to GLP-1 receptor agonists, or severe allergic diseases (asthma, urticaria, eczematous dermatitis, etc.) at screening;
- •Mentally incapacitated or speech-impaired;
- •Suspected or confirmed history of alcohol or drug abuse;
- •Pregnant or lactating woman;
- •The investigator considers that there are any other conditions that make it inappropriate to participate in this study.
结局指标
主要结局
Change From Baseline in Hemoglobin A1c (HbA1c)
时间窗: Week 0 to Week 32
Change from baseline in HbA1c after 32 weeks of treatment.
次要结局
- Change From Baseline in Body Weight(Week 0 to Week 52)
- Change From Baseline in Hemoglobin A1c (HbA1c)(Week 0 to Week 52)
- Percentage of Participants With HbA1c Target Value of <7%(Week 0 to Week 52)
- Percentage of Participants With HbA1c Target Value of <5.7%(Week 0 to Week 52)
- Change From Baseline in Fasting Serum Glucose(Week 0 to Week 52)
研究者
研究点 (1)
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