Comparing Beinaglutide and Insulin for New Type 2 Diabetes Patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study compares the efficacy and safety of continuous subcutaneous Beinaglutide infusion with continuous subcutaneous insulin infusion (CSII) in adults who have recently been diagnosed with type 2 diabetes. Participants will receive Beinaglutide via a pump during meals, while the control group will receive insulin. The study includes an 8-week treatment phase followed by a 12-week post-treatment follow-up to assess disease control and safety outcomes. It is a multicenter, randomized, open-label trial with parallel controls.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Age 18 to 70 years (inclusive) at enrollment, regardless of gender.
2. Voluntary signing of the informed consent form.
3. Newly diagnosed type 2 diabetes mellitus patients, diagnosed according to the WHO 1999 criteria, with a disease duration ≤1 year.
4. HbA1c between 7.5% and 10.0%.
5. BMI between 24 kg/m² and 42 kg/m².
6. 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).
7. 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.

Exclusion Criteria:

1. Patients with type 1 diabetes or other types of diabetes.
2. 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.
3. History of pancreatitis.
4. Family history of medullary thyroid carcinoma.
5. History of malignant tumors.
6. ALT, AST \>3 times the upper limit of normal, and/or total bilirubin \>2 times the upper limit of normal.
7. Moderate to severe renal insufficiency (eGFR \<60 ml/min/1.73m²).
8. Triglycerides ≥5.0 mmol/L.
9. Multiple endocrine neoplasia type 2 (MEN 2).
10. Participation in any pre-marketing drug study within 3 months.
11. Use or expected use of systemic corticosteroids, immunosuppressants, or cytotoxic drugs during the study period.
12. History of diabetic ketoacidosis or non-ketotic hyperosmolar coma within 6 months prior to screening.
13. Blood pressure exceeding the following criteria (untreated or treated): systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg.
14. 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).
15. Allergy to binaclotide or any component of the study drug, or allergy to insulin or any component of the insulin used in the study.
16. Presence of other severe diseases that may interfere with the study, as judged by the investigator.
17. Pregnant or breastfeeding women.
18. Poor compliance, as judged by the investigator, and inability to complete the study as required.
19. 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.
20. Any other factors deemed unsuitable for participation in the study by the investigator.

Where it's running

• Pinggu District Hospital
  Beijing, Beijing Municipality, China Recruiting
• Capital Medical University Beijing Anzhen Hospital
  Beijing, Beijing Municipality, China Recruiting
• Emergency General Hospital
  Beijing, Beijing Municipality, China Recruiting
• Peking University Shougang Hospital
  Beijing, Beijing Municipality, China Recruiting
• Southern Medical University Nanfang Hospital
  Guangzhou, Guangdong, China Recruiting
• Harbin Medical University Second Hospital
  Harbin, Heilongjiang, China Recruiting

Study contacts

• Study coordinator: Lixin Guo, M.D.，Ph.D.
• Email: glx1218@163.com
• Phone: +8613901317569

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.