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临床试验/NCT03987308
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

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

发起方
Beijing Hospital
申办方类型
Other Gov
责任方
Sponsor

研究点 (16)

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