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

Beijing Hospital115 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

115

Conditions

Type 2 Diabetic Patients T2DM (Type 2 Diabetes Mellitus)T2DM

Interventions

BeinaglutideDRUG

Beinaglutide (continuous subcutaneous infusion)

Insulin aspartDRUG

Insulin aspart (CSII)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (16)

Pinggu District Hospital

Beijing, Beijing Municipality, China

RECRUITING

Capital Medical University Beijing Anzhen Hospital

Outcomes

Primary Outcomes

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.

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..

Time frame: From baseline to the end of treatment at 8 week

Secondary Outcomes

Proportion of subjects achieving HbA1c reduction <7% after 8 weeks of treatment.

Proportion of participants achieving a reduction in HbA1c levels to below 7% after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Changes in fasting blood glucose from baseline after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Changes in postprandial blood glucose from baseline after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Changes in HbA1C from baseline after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Proportion of subjects with weight reduction ≥5% from baseline after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Central Contacts

Lixin Guo, M.D.，Ph.D.

CONTACT

+8613901317569 glx1218@163.com

Dongni Yu, M.D.

CONTACT

+8613621273587 yudongni@outlook.com

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.

Beijing, Beijing Municipality, China

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

...and 6 more locations

Changes in weight from baseline after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Changes in waist circumference from baseline after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Changes in waist-to-hip ratio from baseline after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Changes in fasting insulin from baseline after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Changes in fasting C-peptide from baseline after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Changes in HOMA-β from baseline after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Changes in HOMA-IR from baseline after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Changes in lipid profile from baseline after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Changes in blood pressure baseline after 8 weeks of treatment.

Changes in blood pressure (assessing both of systolic and diastolic pressure) from baseline after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Changes in heart rate from baseline after 8 weeks of treatment.

Time frame: From baseline to the end of treatment at 8 week

Proportion of subjects achieving HbA1c <6.5% at 20 weeks.

Proportion of subjects achieving HbA1c \<6.5% at 20 weeks.

Time frame: From baseline to week 20

Proportion of subjects achieving HbA1c <7% at 20 weeks.

Proportion of subjects achieving HbA1c \<7% at 20 weeks.

Time frame: From baseline to week 20

Proportion of subjects with fasting blood glucose <7.0 mmol/L at 20 weeks.

Proportion of subjects with fasting blood glucose \<7.0 mmol/L at 20 weeks.

Time frame: From baseline to week 20

Changes in weight from baseline at 20 weeks.

Time frame: From baseline to week 20

Changes in BMI from baseline at 20 weeks.

Time frame: From baseline to week 20

Changes in waist-to-hip ratio from baseline at 20 weeks.

Time frame: From baseline to week 20

Changes in fasting blood glucose from baseline at 20 weeks.

Changes in fasting blood glucose HbA1c from baseline at 20 weeks.

Time frame: From baseline to week 20

Changes in postprandial blood glucose from baseline at 20 weeks.

Time frame: From baseline to week 20

Changes in HbA1c from baseline at 20 weeks.

Time frame: From baseline to week 20

Changes in HOMA-β from baseline at 20 weeks.

Time frame: From baseline to week 20

Changes in HOMA-IR from baseline at 20 weeks.

Time frame: From baseline to week 20

Changes in fasting insulin from baseline at 20 weeks.

Time frame: From baseline to week 20

Changes in fasting C-peptide from baseline at 20 weeks.

Time frame: From baseline to week 20

Changes in lipid profile from baseline at 20 weeks.

Time frame: From baseline to week 20