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Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM 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
Lead sponsor
Asset
Beinaglutide
Subcutaneous · GLP-1 agonist
Listed sites
16
Recruiting sites
16
Enrollment
115
estimated
Study population
Obesity / overweight, Type 2 diabetes
Key I/E criterion
•HbA1c 7.5-10%
Primary endpoint
•HbA1c <7.0%, no weight increase (≤0 kg) (HbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia, Severe hypoglycemia)
Footprint
Where this trial recruits
Site locations as reported to ClinicalTrials.gov. Site count is not enrollment count; per-site enrollment is not available from source.
Identifiers
Registered as
Timeline
Milestones
Assets
Investigational agents
Study populations
Who this study enrolls
Eligibility
Who can enroll
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.
Endpoints (30)
What's being measured
Protocol endpoints and posted registry outcome measures, grouped into outcome categories. Composite endpoints show their component event types. Standard codes (LOINC, SNOMED CT) are shown where available.
Coverage by outcome category
Weight & body composition
7 endpointsProportion 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
≥5% weight-loss responders
threshold achievement, improvement
Changes in weight from baseline after 8 weeks of treatment.
Time frame:From baseline to the end of treatment at 8 week
Body weight, absolute change (kg)
change from baseline, improvement
Changes in waist circumference from baseline after 8 weeks of treatment.
Time frame:From baseline to the end of treatment at 8 week
Waist circumference, change
change from baseline, improvement
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
change from baseline, improvement
Changes in weight from baseline at 20 weeks.
Time frame:From baseline to week 20
Body weight, absolute change (kg)
change from baseline, improvement
Changes in BMI from baseline at 20 weeks.
Time frame:From baseline to week 20
BMI, change
change from baseline, improvement
Changes in waist-to-hip ratio from baseline at 20 weeks.
Time frame:From baseline to week 20
change from baseline, improvement
Glycemic / diabetes
19 endpointsThe 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.
Time frame:From baseline to the end of treatment at 8 week
threshold achievement, improvement
componentsHbA1c <7.0% achievement, Body weight, absolute change (kg), Documented hypoglycemia, Severe hypoglycemia
Proportion of subjects achieving HbA1c reduction <7% after 8 weeks of treatment.
Time frame:From baseline to the end of treatment at 8 week
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Changes in fasting blood glucose from baseline after 8 weeks of treatment.
Time frame:From baseline to the end of treatment at 8 week
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Changes in postprandial blood glucose from baseline after 8 weeks of treatment.
Time frame:From baseline to the end of treatment at 8 week
Postprandial glucose
change from baseline, improvement
Changes in HbA1C from baseline after 8 weeks of treatment.
Time frame:From baseline to the end of treatment at 8 week
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Changes in fasting insulin from baseline after 8 weeks of treatment.
Time frame:From baseline to the end of treatment at 8 week
change from baseline, improvement
Changes in fasting C-peptide from baseline after 8 weeks of treatment.
Time frame:From baseline to the end of treatment at 8 week
C-peptide AUC
change from baseline, improvement
Changes in HOMA-β from baseline after 8 weeks of treatment.
Time frame:From baseline to the end of treatment at 8 week
change from baseline, improvement
Changes in HOMA-IR from baseline after 8 weeks of treatment.
Time frame:From baseline to the end of treatment at 8 week
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Proportion of subjects achieving HbA1c <6.5% at 20 weeks.
Time frame:From baseline to week 20
HbA1c <6.5% achievement
threshold achievement, improvement
LOINC 4548-4
Proportion of subjects achieving HbA1c <7% at 20 weeks.
Time frame:From baseline to week 20
HbA1c <7.0% achievement
threshold achievement, improvement
LOINC 4548-4
Proportion of subjects with fasting blood glucose <7.0 mmol/L at 20 weeks.
Time frame:From baseline to week 20
Fasting glucose, change
threshold achievement, improvement
LOINC 1558-6
Changes in fasting blood glucose from baseline at 20 weeks.
Time frame:From baseline to week 20
Fasting glucose, change
change from baseline, improvement
LOINC 1558-6
Changes in postprandial blood glucose from baseline at 20 weeks.
Time frame:From baseline to week 20
Postprandial glucose
change from baseline, improvement
Changes in HbA1c from baseline at 20 weeks.
Time frame:From baseline to week 20
HbA1c, change
change from baseline, improvement
LOINC 4548-4
Changes in HOMA-β from baseline at 20 weeks.
Time frame:From baseline to week 20
change from baseline, improvement
Changes in HOMA-IR from baseline at 20 weeks.
Time frame:From baseline to week 20
HOMA-IR (insulin sensitivity)
change from baseline, improvement
Changes in fasting insulin from baseline at 20 weeks.
Time frame:From baseline to week 20
change from baseline, improvement
Changes in fasting C-peptide from baseline at 20 weeks.
Time frame:From baseline to week 20
change from baseline, improvement
Cardiometabolic biomarkers
4 endpointsChanges in lipid profile from baseline after 8 weeks of treatment.
Time frame:From baseline to the end of treatment at 8 week
change from baseline, improvement
Changes in blood pressure baseline after 8 weeks of treatment.
Time frame:From baseline to the end of treatment at 8 week
change from baseline, improvement
Changes in heart rate from baseline after 8 weeks of treatment.
Time frame:From baseline to the end of treatment at 8 week
Heart rate, change
change from baseline, improvement
Changes in lipid profile from baseline at 20 weeks.
Time frame:From baseline to week 20
change from baseline, improvement
Provenance
Sources
Trial facts come from public ClinicalTrials.gov records. Endpoint categories are Delfa's classification of those records, not a ClinicalTrials.gov field. All figures reflect the July 1, 2026 snapshot.