A Multi-center, Randomized, Double-blind, Placebo/Positive Parallel Phase III Clinical Trial to Evaluate the Efficacy and Safety of SAL067 in Type 2 Diabetes Patients Who Cannot Effectively Control Blood Glucose Through Diet and Exercise
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 458
- 试验地点
- 1
- 主要终点
- HbA1c change from baseline at week 24
研究概览
简要总结
This is the first phase 3 randomized, double-blind, placebo/active-controlled clinical study to evaluate the efficacy and long-term safety of SAL067 in treatment-naive T2DM patients uncontrolled with diet and exercise intervention, comprising 24 weeks of double-blind treatment period followed by an open-label treatment period, making up a total of 52 weeks.
详细描述
All eligible subjects would enter the 24 weeks of double-blind treatment period and were randomized into the SAL067 group (12 mg once daily) or alogliptin group (25 mg once daily) or placebo group at a 2:1:1 ratio. After 24 weeks of double-blind treatment, subjects would enter the extended open-label treatment period. Subjects in the placebo group were to be switched to SAL067 (12 mg once daily) treatment, while patients in the SAL067 and alogliptin groups continued the same treatment until the end of the whole 52 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Double-blind
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
- •Type 2 diabetes patients who meet the diagnostic criteria for diabetes issued by the World Health Organization (WHO) in 1999;
- •Men or women aged 18 to 75 years old at the day of signing the informed consent;
- •Body mass index: BMI 19kg/m2 to 35kg/m2, [BMI=weight (kg)/height 2 (m2)];
- •Glycated hemoglobin (HbA1c): Screening period: HbA1c 7.5% to 10.5% (tested by the research center), when randomly enrolled: HbA1c 7.0% to 10.0% (central laboratory test) Measurement);
- •Screening period and random time fasting blood glucose <=13.9mmol/L;
排除标准
- •Drug compliance during the introduction period <80% or >120%;
- •Use other hypoglycemic drugs other than test drugs during the introduction period;
- •The patient may have any contraindications, allergies or hypersensitivity to fuglitagliptin (including study drug and placebo) or its excipients, DPP4 drugs, metformin;
- •Before screening, have any of the following endocrine-related medical history or evidence:
- •Diabetes other than type 2 diabetes, such as type 1 diabetes, single-gene mutation diabetes, diabetes caused by pancreatic injury or secondary diabetes, such as diabetes caused by Cushing's syndrome or acromegaly;
- •diabetic ketoacidosis, hyperglycemia and hyperosmolarity, lactic acidosis and other acute complications of diabetes within 6 months before screening;
- •severe hypoglycemia episodes (such as sleepiness caused by hypoglycemia, unconsciousness, nonsense, and even coma), or a serious history of unconscious hypoglycemia;
- •Before screening, there is a history or evidence of any of the following diseases:
- •Unstable angina, stroke or transient ischemic attack, myocardial infarction, coronary artery bypass graft or percutaneous coronary intervention (diagnostic angiography is allowed of);
- •Decompensated heart failure before screening (New York Heart Association NYHA heart function grades III and IV, persistent and clinically significant arrhythmia;
- •A history of acute and chronic pancreatitis, symptomatic gallbladder disease or history of pancreatic injury, etc. may lead to high risk factors for pancreatitis;
研究组 & 干预措施
SAL067
SAL067 12mg once daily
干预措施: SAL067 (Drug)
Alogliptin
Alogliptin 25mg once daily
干预措施: Alogliptin (Drug)
placebo
placebo once daily
干预措施: Placebo (Drug)
结局指标
主要结局
HbA1c change from baseline at week 24
时间窗: Baseline and week 24
Change From Baseline in Hemoglobin A1c (HbA1c) at week 24
次要结局
- Pancreatic β-cell function change (calculated by HOMA-β ) from baseline at week 24 and week 52(Baseline 、week 24 and week 52)
- Fasting c-peptide change from baseline at week 24 and week 52(Baseline 、week 24 and week 52)
- HbA1c change from baseline at week 4、week 12、week 40 and week 52(Baseline 、week 4、week 12、week 40 and week 52)
- Percentage of patients with HbA1c <7.0% and HbA1c <6.5% at week 24 and week 52(Baseline 、week 24 and week 52)
- Percentage of patients required use of rescue therapy at week 24 and week 52(Baseline 、week 24 and week 52)
- Insulin sensitivity change (calculated by HOMA-IS) from baseline at week 24 and week 52(Baseline 、week 24 and week 52)
- FPG change from baseline at week 4、week 8、week 12、week16、week24、week 40 and week 52(Baseline、week 4、week 8、week 12、week16、week24、week 40 and week 52)