NCT06703268已完成2 期
A Multicenter, Randomized, Open-label, Controlled Study on Evaluating the Efficacy and Safety of Switching From Daily DPP-4 Inhibitors to HSK7653 Tablets in Patients With Type 2 Diabetes Mellitus in China
Haisco Pharmaceutical Group Co., Ltd.1 个研究点 分布在 1 个国家目标入组 64 人开始时间: 2024年1月15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
- 64
- 试验地点
- 1
- 主要终点
- Time in range
研究概览
简要总结
To assess the effectiveness of HSK7653 tablets following the substitution of daily DPP-4 inhibitor (DPP-4i) over a 24-week treatment period.
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
- •Age ≥18 and Age ≤75 years
- •T2DM patients,
- •During the 12 weeks before screening, on the basis of diet control and exercise therapy, patients only regularly received daily DPP-4 inhibitors (such as sitagliptin, vildagliptin, saxagliptin, linagliptin, alogliptin and retagliptin , etc.) or combined with metformin (with a metformin dose of ≥ 1500 mg/day, or the maximum tolerated dose < 1500 mg/day but ≥ 1000 mg/day);
- •HbA1c ≥6.5% and HbA1c <8.0%
- •FPG <10.0 mmol/L
- •BMI ≥19 and BMI ≤ 35 kg/m2 (Body Mass Index)
排除标准
- •Non-type 2 diabetes: Type 1 diabetes, gestational diabetes or other special types of diabetes.
- •The presence of any of the following medical histories or conditions at the time of screening:
- •History of diabetic ketoacidosis or hyperglycemic hyperosmolar state within the recent 6 months;
- •History of ≥2 episodes of severe hypoglycemia within the last 6 months;
- •History of malignant tumors within the recent 5 years (except for cured basal cell carcinoma of the skin and cervical carcinoma in situ), or currently being evaluated for potential malignant tumors.
- •Presence of severe mental disorders or language barriers, unwilling or unable to fully understand and cooperate.
- •History of drug abuse within the past 5 years
- •Previous history or clinical evidence of acute or chronic pancreatitis.
- •Using other drugs that may affect blood glucose metabolism within 12 weeks prior to screening, including systemic glucocorticoids (except for inhaled or topical ones), growth hormones, etc.
- •Any laboratory test index meeting the following criteria:
- •Hemoglobin < 110 g/L (for males) or < 100 g/L (for females).
- •Alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) > 3 times the upper limit of the normal value.
- •Total bilirubin (TBIL) > 2 times the upper limit of the normal value.
- •Fasting triglyceride (TG) > 5.7 mmol/L.
- •Estimated glomerular filtration rate (eGFR) calculated using the CKD-EPI formula < 45 mL/min/1.73m².
- •Known to be allergic to the investigational products or related excipients.
研究组 & 干预措施
HSK7653
Experimental
HSK7653 10mg Q2W
干预措施: HSK7653 10 mg (Drug)
Daily DPP-4 inhibitor
Active Comparator
Daily DPP-4 inhibitor
干预措施: Daily DPP-4 inhibitor (Drug)
结局指标
主要结局
Time in range
时间窗: 24 weeks
The change in time in range (TIR) of continuous glucose monitoring (CGM) relative to the baseline after 24 weeks of treatment.
次要结局
- HbA1c(24 weeks)
- Fasting glucose(24 weeks)
- Mean glucose(24 weeks)
- Treatment-emergent adverse events.(24 weeks)
研究者
研究点 (1)
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