NCT07244003招募中4 期
Efficacy and Safety of the Triple Combination Therapy of Met/SGLT-2i/GLP-1RA or Other Oral Antidiabetic Drugs in Patients With Type 2 Diabetes Exhibiting Poor Glycemic Control
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 430
- 试验地点
- 1
- 主要终点
- The change of HbA1c compared to the baseline
研究概览
简要总结
The main objective of this study is to compare the efficacy and safety of the triple combination therapy of Met/SGLT-2i/GLP-1RA or other oral antidiabetic drugs in patients with type 2 diabetes exhibiting poor glycemic control.
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
- •Meet the diagnostic criteria for type 2 diabetes (refer to the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020 edition)); -Age: 18-75 years old (including the threshold), male or female;
- •Body mass index (BMI) ≥20kg/m² ;
- •Patients who took 1000mg or more of metformin in combination with or without another oral hypoglycemic agent (except SGLT-2i and oral GLP-1RA) for at least 8 weeks before screening and had poor blood glucose control (centralized detection of HBA1C >=7.5% and<=11.0%);
- •Volunteer to participate in this study and sign informed consent.
排除标准
- •Patients with type 1 diabetes or other special types of diabetes;
- •Patients with acute complications of ketoacidosis/hyperglycemic hyperosmolar state/lactic acidosis within 6 months before screening
- •Those who have used GLP-1RA and SGLT-2i drugs within 12 weeks before screening, or have used GLP-1RA and SGLT-2i drugs in the past and discontinued due to poor efficacy
- •Those who received insulin treatment within the previous week
- •Those who have a history of chronic or acute pancreatitis before screening, or have clinical manifestations of pancreatitis at the time of screening, or fasting triglycerides > 5.7 mmol/L during the screening period
- •Liver function impairment at screening: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 UNL, or total blood bilirubin (TBIL) > 2 UNL;
- •Renal impairment at screening: calculated according to the CKD-EPI formula, eGFR≤45 mL/min/1.73m² or serum creatinine≥1.5 UNL;
- •Patients with a past or family history of medullary thyroid cancer (MTC) and patients with multiple endocrine neoplasia syndrome type 2 (MEN2)
- •Female subjects who are currently pregnant, breastfeeding, or have a pregnancy plan during the study period
- •Those who have a history of hypersensitivity reaction to metformin, gapagliflozin, liraglutide injection and other drugs used in research and their excipients or have contraindications to the study drugs;
- •Those who have participated in other drug clinical trials within 3 months before screening;
- •Subjects who are unable to comply with the protocol under the judgment of the investigator, and those who have other serious physical or psychological diseases that may affect the effectiveness and safety.
研究组 & 干预措施
Met+SGLT-2i+GLP-1RA
Experimental
Metformin+Ganagliflozin+Liraglutide
干预措施: Metformin (Drug)
Met+SGLT-2i+GLP-1RA
Experimental
Metformin+Ganagliflozin+Liraglutide
干预措施: ganagliflozin (Drug)
Met+SGLT-2i+GLP-1RA
Experimental
Metformin+Ganagliflozin+Liraglutide
干预措施: liraglutide (Drug)
Triple Therapy of Other Oral Antidiabetic Drugs
Active Comparator
Building upon the previously stable treatment regimen, the addition of 1-2 oral hypoglycemic agents (excluding SGLT-2 inhibitors and oral GLP-1 receptor agonists) constitutes a triple oral hypoglycemic regimen.
干预措施: Triple Therapy of Other Oral Antidiabetic Drugs (Drug)
结局指标
主要结局
The change of HbA1c compared to the baseline
时间窗: from baseline to week 24
次要结局
- The changes of waist-hip ratio, waist-to-height ratio compared to the baseline(from baseline to 24 week)
- The changes of fasting blood glucose, 2-hour post-meal blood glucose, fasting glucagon, fasting insulin, insulin resistance index (HOMA-IR) compared to the baseline(from baseline to week 24)
- Changes in systolic and diastolic blood pressure compared to the baseline(from baseline to week 24)
- The changes in urine albumin-to-creatinine ratio (UACR) compared to the baseline(from baseline to week 24)
- The changes of body mass compared to the baseline(from baseline to 24 week)
- The changes of BMI compared to the baseline(from baseline to 24 week)
- The changes of waist circumference and hip circumference compared to the baseline(from baseline to week 24)
- The proportion of participants achieving HbA1c, blood pressure, and cholesterol targets(week 24)
- The proportion of patients achieving HbA1c target without hypoglycemia or weight gainning(week 24)
研究者
研究点 (1)
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