NCT03987308招募中不适用
Comparing the Efficacy and Safety Between Short-term Continuous Subcutaneous Beinaglutide Injection and Continuous Subcutaneous Insulin Infusion (CSII) for Treatment of Patients With Newly Diagnosed Type 2 Diabetes: a Multicenter, Randomized Open Trial Study With Parallel Controls
Beijing Hospital16 个研究点 分布在 1 个国家目标入组 115 人开始时间: 2019年7月2日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 115
- 试验地点
- 16
- 主要终点
- The proportion of subjects achieving HbA1c <7.0%, no weight increase (≤0 kg), and no hypoglycemia (blood glucose ≤3.9 mmol/L or severe hypoglycemia) after 8 weeks of treatment.
研究概览
简要总结
The efficacy, safety and post-treatment disease control will be compared between groups of continuous subcutaneous Beinaglutide infusion and continuous subcutaneous insulin infusion (CSII) in adult patients with newly diagnosed type 2 diabetes.
详细描述
Based on the dual roles of glucagon-like peptide 1 (GLP-1) in regulating fasting blood glucose and postprandial blood glucose secretion, we adopted a combinational therapeutic model and will administer drug treatments during meals. Newly diagnosed type 2 diabetic patients will be administered continuous subcutaneous Beinaglutide injections using a pump device. The efficacy, safety and disease control after terminating the drug treatments will be compared to those of patients who receive CSII treatment.
This is a national-level, multicenter, randomized, open study with parallel controls. The study consists of two phases:
a 8-week treatment phase and a 12-week post-treatment follow-up 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 70 years (inclusive) at enrollment, regardless of gender.
- •Voluntary signing of the informed consent form.
- •Newly diagnosed type 2 diabetes mellitus patients, diagnosed according to the WHO 1999 criteria, with a disease duration ≤1 year.
- •HbA1c between 7.5% and 10.0%.
- •BMI between 24 kg/m² and 42 kg/m².
- •Subjects who have not taken antidiabetic medications or have used oral antidiabetic medications for less than 3 months and have discontinued for more than 1 month (calculated from the date of signing the informed consent form).
- •Subjects with reproductive potential (including male subjects whose partners have reproductive potential) agree to use effective contraception during the study and for 1 month after study completion.
排除标准
- •Patients with type 1 diabetes or other types of diabetes.
- •History of obstructive intestinal diseases or potential complications: subjects with post-abdominal surgery or peritoneal infection-related intestinal adhesions, intestinal obstruction sequelae; subjects with intestinal motility disorders, chronic constipation; subjects with a history of Crohn's disease or ulcerative colitis.
- •History of pancreatitis.
- •Family history of medullary thyroid carcinoma.
- •History of malignant tumors.
- •ALT, AST >3 times the upper limit of normal, and/or total bilirubin >2 times the upper limit of normal.
- •Moderate to severe renal insufficiency (eGFR <60 ml/min/1.73m²).
- •Triglycerides ≥5.0 mmol/L.
- •Multiple endocrine neoplasia type 2 (MEN 2).
- •Participation in any pre-marketing drug study within 3 months.
- •Use or expected use of systemic corticosteroids, immunosuppressants, or cytotoxic drugs during the study period.
- •History of diabetic ketoacidosis or non-ketotic hyperosmolar coma within 6 months prior to screening.
- •Blood pressure exceeding the following criteria (untreated or treated): systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg.
- •History of any of the following cardiovascular diseases within 3 months prior to screening: acute myocardial infarction, New York Heart Association functional class III/IV heart failure or left ventricular ejection fraction ≤40%, or cerebrovascular event (stroke).
- •Allergy to binaclotide or any component of the study drug, or allergy to insulin or any component of the insulin used in the study.
- •Presence of other severe diseases that may interfere with the study, as judged by the investigator.
- •Pregnant or breastfeeding women.
- •Poor compliance, as judged by the investigator, and inability to complete the study as required.
- •Inability to undergo continuous pump infusion: subjects allergic to subcutaneous infusion tubes or adhesive tape; subjects unwilling to have long-term subcutaneous infusion tubes or continuous pump use; subjects with psychological aversion to pump therapy; subjects or their families lack relevant knowledge and are unable to master the use after training; subjects with severe psychological disorders or mental abnormalities; subjects who are unable to care for themselves and have no caregivers.
- •Any other factors deemed unsuitable for participation in the study by the investigator.
研究组 & 干预措施
Continuous Beinaglutide infusion
Experimental
8-week Beinaglutide (continuous subcutaneous infusion) treatment group
干预措施: Beinaglutide (Drug)
Continuouns Insulin aspart infusion
Active Comparator
8-week insulin aspart (CSII) treatment group
干预措施: Insulin aspart (Drug)
结局指标
主要结局
The proportion of subjects achieving HbA1c <7.0%, no weight increase (≤0 kg), and no hypoglycemia (blood glucose ≤3.9 mmol/L or severe hypoglycemia) after 8 weeks of treatment.
时间窗: From baseline to the end of treatment at 8 week
The primary endpoint of the trial is a composite endpoint of HbA1c \<7.0%, no weight increase (≤0 kg), and no hypoglycemia (blood glucose ≤3.9 mmol/L or severe hypoglycemia) after 8 weeks of treatment..
次要结局
- Changes in BMI from baseline at 20 weeks.(From baseline to week 20)
- Changes in waist-to-hip ratio from baseline at 20 weeks.(From baseline to week 20)
- Changes in fasting blood glucose from baseline at 20 weeks.(From baseline to week 20)
- Changes in postprandial blood glucose from baseline at 20 weeks.(From baseline to week 20)
- Changes in HbA1c from baseline at 20 weeks.(From baseline to week 20)
- Changes in HOMA-β from baseline at 20 weeks.(From baseline to week 20)
- Changes in fasting blood glucose from baseline after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Changes in postprandial blood glucose from baseline after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Changes in HbA1C from baseline after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Proportion of subjects with weight reduction ≥5% from baseline after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Changes in weight from baseline after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Proportion of subjects achieving HbA1c reduction <7% after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Changes in fasting C-peptide from baseline after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Changes in HOMA-β from baseline after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Changes in waist circumference from baseline after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Changes in waist-to-hip ratio from baseline after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Changes in fasting insulin from baseline after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Changes in HOMA-IR from baseline after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Changes in lipid profile from baseline after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Changes in blood pressure baseline after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Changes in heart rate from baseline after 8 weeks of treatment.(From baseline to the end of treatment at 8 week)
- Proportion of subjects achieving HbA1c <6.5% at 20 weeks.(From baseline to week 20)
- Proportion of subjects achieving HbA1c <7% at 20 weeks.(From baseline to week 20)
- Proportion of subjects with fasting blood glucose <7.0 mmol/L at 20 weeks.(From baseline to week 20)
- Changes in weight from baseline at 20 weeks.(From baseline to week 20)
- Changes in HOMA-IR from baseline at 20 weeks.(From baseline to week 20)
- Changes in fasting insulin from baseline at 20 weeks.(From baseline to week 20)
- Changes in fasting C-peptide from baseline at 20 weeks.(From baseline to week 20)
- Changes in lipid profile from baseline at 20 weeks.(From baseline to week 20)
研究者
研究点 (16)
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