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

Recruiting now · Not applicable

Conditions studied: Type 2 Diabetic Patients, T2DM (Type 2 Diabetes Mellitus), T2DM

In brief

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.

Key facts

Study ID

NCT03987308

Run by

Beijing Hospital

People needed

115

Starts

2019-07-02

Expected to finish

2025-12-01

Last updated by the study team

2025-05-02

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Pinggu District Hospital — Beijing, Beijing Municipality, China (enrolling)
• Capital Medical University Beijing Anzhen Hospital — Beijing, Beijing Municipality, China (enrolling)
• Emergency General Hospital — Beijing, Beijing Municipality, China (enrolling)
• Peking University Shougang Hospital — Beijing, Beijing Municipality, China (enrolling)
• Southern Medical University Nanfang Hospital — Guangzhou, Guangdong, China (enrolling)
• Harbin Medical University Second Hospital — Harbin, Heilongjiang, China (enrolling)
• Southeast University Zhongda Hospital — Nanjing, Jiangsu, China (enrolling)
• Xuzhou Medical University Affiliated Hospital — Xuzhou, Jiangsu, China (enrolling)
• China-Japan Union Hospital of Jilin University — Changchun, Jilin, China (enrolling)
• Jilin University Second Hospital — Changchun, Jilin, China (enrolling)
• Xi'an Jiaotong University Second Hospital — Xi'an, Shaanxi, China (enrolling)
• Southwest Medical University Affiliated Hospital — Luzhou, Sichuan, China (enrolling)
• Peking University Binhai Hospital — Tianjin, Tianjin Municipality, China (enrolling)
• First Hospital of Peking University — Beijing, China (enrolling)
• Heilongjiang provincial hospital — Harbin, China (enrolling)
• Henan People's Hospital — Zhengzhou, China (enrolling)

Full record on ClinicalTrials.gov

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