A Multicenter, Randomized, Double-Blind, Placebo and Active Comparator-Controlled, Phase II Clinical Study to Evaluate the Efficacy and Safety of SYH2069 Injection in Participants With Type 2 Diabetes Mellitus With Inadquate Glycemic Control After Diet and Exercise Alone or Metformin Monotherapy
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 240
- 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 study is a multicenter, randomized, double-blind, placebo and active-controlled, dose-finding phase 2 study aimed to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SYH2069 Injection in participants with Type 2 Diabetes Mellitus (T2DM) inadequate glycemic control with diet and exercise alone or metformin monotherapy.
The study consists of four periods: a 2-week screening period, a 3-week run-in period, a 28-week treatment period and a 3-week safety follow-up period.
A total of 240 subjects will be enrolled. All subjects will be stratified by baseline HbA1c levels (≤8.5% or >8.5%) and prior metformin use (yes or no) , then randomized 4:1:4:1:4:1:4:1:4 to SYH2069 group 1, SYH2069 group 1 placebo, SYH2069 group 2, SYH2069 group 2 placebo, SYH2069 group 3, SYH2069 group 3 placebo, SYH2069 group 4, SYH2069 group 4 placebo and Tirzepatide injection 15mg, with 40 participants in each SYH2069 or Tirzepatide group and 10 participants in each SYH2069 placebo group. All treatment groups will implement dose titration to achieve the target dose.
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)
盲法说明
Open-label between treatment arms，double-blind within each treatment arm
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
- •1. Male or female participants, 18-75 years of age.
- •2. Confirmed as T2DM for at least 12 weeks.
- •3. Body Mass Index (BMI): 22 kg/m^2 ≤ BMI ≤ 40 kg/m^
- •4. Treated with lifestyle intervention and stable treatment with metformin at least 8 weeks prior to screening.
- •5. HbA1c 7.5-10.5% (both inclusive) at screening visit.
- •6. Able to understand the protocol, and voluntarily signed informed consent.
排除标准
- •1. Type 1 diabetes or other specific types of diabetes.
- •2. Allergy to any active ingredient or any excipient of the investigational product, or presence of severe allergic diseases at screening.
- •3. Weight change >5% within 1 month before screening.
- •4. History of a level 3 hypoglycemic episode within 6 months prior to screening.
- •5. Acute complications of diabetes occurred within 6 months prior to screening.
- •6. History of severe chronic diabetic complications within 6 months prior to screening, or have non-proliferative diabetic retinopathy that requires treatment during the study.
- •7. History of acute or chronic pancreatitis.
- •8. History of acute cardiovascular and cerebrovascular within 6 months prior to screening.
- •9. History of malignancy of any organ system within 5 years prior to screening, excluding cured basal cell carcinoma and carcinoma in situ.
- •10. History or family history of medullary thyroid carcinoma (MTC), thyroid C-cell hyperplasia, or multiple endocrine neoplasia type 2 (MEN2).
- •11. History of major surgery or suffered blood loss of more than 400 mL within 3 months prior to screening.
- •12. Pregnant or lactating woman.
- •13. Other conditions judged by the investigator to be unsuitable for participation in this trial.
研究组 & 干预措施
SYH2069 Injection (group 1)
Participants received SYH2069 Injection dose 1 subcutaneously for 28 weeks
干预措施: SYH2069 Injection (group 1) (Drug)
SYH2069 Injection (group2)
Participants received SYH2069 Injection dose 2 subcutaneously for 28 weeks
干预措施: SYH2069 Injection (group 2) (Drug)
SYH2069 Injection (group 3)
Participants received SYH2069 Injection dose 3 subcutaneously for 28 weeks
干预措施: SYH2069 Injection (group 3) (Drug)
SYH2069 Injection (group 4)
Participants received SYH2069 Injection dose 4 subcutaneously for 28 weeks
干预措施: SYH2069 Injection (group 4) (Drug)
SYH2069 Injection placebo
Participants received SYH2069 Injection placebo subcutaneously for 28 weeks
干预措施: SYH2069 Injection placebo (Drug)
Tirzepatide Injection 15mg
Participants received Tirzepatide Injection 15mg subcutaneously for 28 weeks
干预措施: Tirzepatide Injection 15mg (Drug)
结局指标
主要结局
Change from baseline in Hemoglobin A1c (HbA1c)
时间窗: Baseline，Week 28
次要结局
- Change from Baseline in Fasting Plasma Glucose (FPG)(Baseline，Week 28)
- The percentage of participants reaching the HbA1c target of<7.0% and≤6.5%(Baseline，Week 28)
- Change from baseline in 2-hour postprandial plasma glucose (2h-PPG)(Baseline，Week 28)
- Changes from baseline in the mean 7-point glucose profile and mean postprandial glucose increment as measured by Self Monitoring of Blood Glucose (SMBG)(Baseline，Week 28)
- Change from body weight(Baseline，Week 28)
- Change from waist circumference(Baseline，Week 28)
- Change from hip circumference(Baseline，Week 28)
- Change from waist-to-hip ratio(Baseline，Week 28)
- Change from Baseline in blood lipids(Baseline，Week 28)
- Change from Baseline in blood pressure [Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)](Baseline，Week 28)
- Change from Baseline in Urinary Albumin to Creatinine Ratio (UACR)(Baseline，Week 28)