A Randomized, Double-blind, Placebo-Controlled Trial Comparing the Efficacy and Safety of BGM0504 Versus Placebo in Patients with Type 2 Diabetes, Inadequately Controlled with Diet and Exercise Alone
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 207
- 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 is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the efficacy and safety of BGM0504 in patients with type 2 diabetes (T2D) with poor glycemic control only through diet and exercise.
The main purpose is to evaluate the clinical efficacy of BGM0504 injection monotherapy for 32 weeks compared with placebo in Chinese patients with type 2 diabetes with poor glycemic control only through diet and exercise, and to evaluate the clinical efficacy and safety of BGM0504 injection for 52 weeks of administration.
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
- Double (Participant, Investigator)
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);
- •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%；
- •Fasting Plasma Glucose (FPG) ≤ 15.0 mmoL/L.
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.
研究组 & 干预措施
Experimental: 5 mg BGM0504
Experimental: 5 mg BGM0504 5 milligrams (mg) BGM0504 administered subcutaneously (SC) once a week.
干预措施: Drug: 5 mg BGM0504 Administered SC (Drug)
Experimental: 10 mg BGM0504
Experimental: 10 mg BGM0504 10 mg BGM0504 administered SC once a week.
干预措施: Drug: : 10 mg BGM0504 Administered SC (Drug)
Placebo Comparator: Placebo
Placebo Comparator: Placebo Placebo administered subcutaneously (SC) once a week.
干预措施: Drug: Placebo Administered SC (Drug)
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)