Comparing Beinaglutide and Insulin for New Type 2 Diabetes Patients

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

This study is testing whether a new treatment called Beinaglutide works better than insulin for adults who have just been diagnosed with type 2 diabetes.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 115 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Beijing Hospital (other gov)
• Locations: 16 sites (Beijing, Beijing Municipality and 15 other locations)
• Trial ID: NCT03987308 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 70 with newly diagnosed type 2 diabetes and specific HbA1c and BMI criteria.

Not a fit: Patients with type 1 diabetes or other types of diabetes will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a new effective treatment option for managing newly diagnosed type 2 diabetes.

How similar studies have performed: Other studies have shown promising results with GLP-1 receptor agonists, suggesting potential success for this approach.

Eligibility criteria

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 this trial is running

Beijing, Beijing Municipality and 15 other locations

• 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)
• Southeast University Zhongda Hospital — Nanjing, Jiangsu, China (RECRUITING)
• Xuzhou Medical University Affiliated Hospital — Xuzhou, Jiangsu, China (RECRUITING)
• China-Japan Union Hospital of Jilin University — Changchun, Jilin, China (RECRUITING)
• Jilin University Second Hospital — Changchun, Jilin, China (RECRUITING)
• Xi'an Jiaotong University Second Hospital — Xi'an, Shaanxi, China (RECRUITING)
• Southwest Medical University Affiliated Hospital — Luzhou, Sichuan, China (RECRUITING)
• Peking University Binhai Hospital — Tianjin, Tianjin Municipality, China (RECRUITING)
• First Hospital of Peking University — Beijing, China (RECRUITING)
• Heilongjiang provincial hospital — Harbin, China (RECRUITING)
• Henan People's Hospital — Zhengzhou, China (RECRUITING)

Study contacts

• Study coordinator: Lixin Guo, M.D.，Ph.D.

Conditions: Type 2 Diabetic Patients, T2DM, beinaglutide, CSII, subcutaneous pump