Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат Beinaglutide
  Beinaglutide (continuous subcutaneous infusion)
• Препарат Insulin aspart
  Insulin aspart (CSII)

Первичные конечные точки

• 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. [Срок оценки: From baseline to the end of treatment at 8 week]

Вторичные конечные точки (12)

• Proportion of subjects achieving HbA1c reduction <7% after 8 weeks of treatment. [Срок оценки: From baseline to the end of treatment at 8 week]
• Changes in fasting blood glucose from baseline after 8 weeks of treatment. [Срок оценки: From baseline to the end of treatment at 8 week]
• Changes in postprandial blood glucose from baseline after 8 weeks of treatment. [Срок оценки: From baseline to the end of treatment at 8 week]
• Changes in HbA1C from baseline after 8 weeks of treatment. [Срок оценки: From baseline to the end of treatment at 8 week]
• Proportion of subjects with weight reduction ≥5% from baseline after 8 weeks of treatment. [Срок оценки: From baseline to the end of treatment at 8 week]
• Changes in weight from baseline after 8 weeks of treatment. [Срок оценки: From baseline to the end of treatment at 8 week]
• Changes in waist circumference from baseline after 8 weeks of treatment. [Срок оценки: From baseline to the end of treatment at 8 week]
• Changes in waist-to-hip ratio from baseline after 8 weeks of treatment. [Срок оценки: From baseline to the end of treatment at 8 week]
• Changes in fasting insulin from baseline after 8 weeks of treatment. [Срок оценки: From baseline to the end of treatment at 8 week]
• Changes in fasting C-peptide from baseline after 8 weeks of treatment. [Срок оценки: From baseline to the end of treatment at 8 week]
• Changes in HOMA-β from baseline after 8 weeks of treatment. [Срок оценки: From baseline to the end of treatment at 8 week]
• Changes in HOMA-IR from baseline after 8 weeks of treatment. [Срок оценки: From baseline to the end of treatment at 8 week]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 16 центров

• Pinggu District Hospital — Пекин
• Capital Medical University Beijing Anzhen Hospital — Пекин
• Emergency General Hospital — Пекин
• Peking University Shougang Hospital — Пекин
• Southern Medical University Nanfang Hospital — Гуанчжоу
• Harbin Medical University Second Hospital — Харбин
• Southeast University Zhongda Hospital — Нанкин
• Xuzhou Medical University Affiliated Hospital — Xuzhou
• … и ещё 8 центров

Идентификаторы

NCT: NCT03987308 · BN-IIT-IS-008

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗