Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients
1 other identifier
interventional
115
1 country
16
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2019
Longer than P75 for not_applicable
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 12, 2019
CompletedFirst Posted
Study publicly available on registry
June 17, 2019
CompletedStudy Start
First participant enrolled
July 2, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2025
CompletedMay 2, 2025
April 1, 2025
6.2 years
June 12, 2019
April 30, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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..
From baseline to the end of treatment at 8 week
Secondary Outcomes (29)
Proportion of subjects achieving HbA1c reduction <7% after 8 weeks of treatment.
From baseline to the end of treatment at 8 week
Changes in fasting blood glucose from baseline after 8 weeks of treatment.
From baseline to the end of treatment at 8 week
Changes in postprandial blood glucose from baseline after 8 weeks of treatment.
From baseline to the end of treatment at 8 week
Changes in HbA1C from baseline after 8 weeks of treatment.
From baseline to the end of treatment at 8 week
Proportion of subjects with weight reduction ≥5% from baseline after 8 weeks of treatment.
From baseline to the end of treatment at 8 week
- +24 more secondary outcomes
Study Arms (2)
Continuous Beinaglutide infusion
EXPERIMENTAL8-week Beinaglutide (continuous subcutaneous infusion) treatment group
Continuouns Insulin aspart infusion
ACTIVE COMPARATOR8-week insulin aspart (CSII) treatment group
Interventions
Eligibility Criteria
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.
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Beijing Hospitallead
Study Sites (16)
Pinggu District Hospital
Beijing, Beijing Municipality, 000, China
Capital Medical University Beijing Anzhen Hospital
Beijing, Beijing Municipality, China
Emergency General Hospital
Beijing, Beijing Municipality, China
Peking University Shougang Hospital
Beijing, Beijing Municipality, China
Southern Medical University Nanfang Hospital
Guangzhou, Guangdong, 000, China
Harbin Medical University Second Hospital
Harbin, Heilongjiang, China
Southeast University Zhongda Hospital
Nanjing, Jiangsu, 000, China
Xuzhou Medical University Affiliated Hospital
Xuzhou, Jiangsu, China
China-Japan Union Hospital of Jilin University
Changchun, Jilin, China
Jilin University Second Hospital
Changchun, Jilin, China
Xi'an Jiaotong University Second Hospital
Xi'an, Shaanxi, 000, China
Southwest Medical University Affiliated Hospital
Luzhou, Sichuan, 000, China
Peking University Binhai Hospital
Tianjin, Tianjin Municipality, China
First Hospital of Peking University
Beijing, 100034, China
Heilongjiang provincial hospital
Harbin, 150030, China
Henan People's Hospital
Zhengzhou, 450003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 12, 2019
First Posted
June 17, 2019
Study Start
July 2, 2019
Primary Completion
September 1, 2025
Study Completion
December 1, 2025
Last Updated
May 2, 2025
Record last verified: 2025-04
Data Sharing
- IPD Sharing
- Will not share