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Clinical Trial NCT03987308 for Type 2 Diabetic Patients, T2DM (Type 2 Diabetes Mellitus), T2DM is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients 115
Clinical Trial NCT03987308 is an interventional study for Type 2 Diabetic Patients, T2DM (Type 2 Diabetes Mellitus), T2DM that is recruiting. It started on July 2, 2019 with plans to enroll 115 participants. Led by Beijing Hospital, it is expected to complete by December 1, 2025. The latest data from ClinicalTrials.gov was last updated on May 2, 2025.
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.
Detailed Description
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 terminatin...Show More
Official Title
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
Conditions
Type 2 Diabetic PatientsT2DM (Type 2 Diabetes Mellitus)T2DMOther Study IDs
- BN-IIT-IS-008
NCT ID Number
Start Date (Actual)
2019-07-02
Last Update Posted
2025-05-02
Completion Date (Estimated)
2025-12
Enrollment (Estimated)
115
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Keywords
T2DM
beinaglutide
CSII
subcutaneous pump
beinaglutide
CSII
subcutaneous pump
Primary Purpose
Treatment
Design Allocation
Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalContinuous Beinaglutide infusion 8-week Beinaglutide (continuous subcutaneous infusion) treatment group | Beinaglutide Beinaglutide (continuous subcutaneous infusion) |
Active ComparatorContinuouns Insulin aspart infusion 8-week insulin aspart (CSII) treatment group | Insulin aspart Insulin aspart (CSII) |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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 |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | From baseline to the end of treatment at 8 week |
Changes in fasting blood glucose from baseline after 8 weeks of treatment. | 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. | 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. | 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. | Proportion of subjects with weight reduction ≥5% from baseline after 8 weeks of treatment. | From baseline to the end of treatment at 8 week |
Changes in weight from baseline after 8 weeks of treatment. | Changes in weight from baseline after 8 weeks of treatment. | From baseline to the end of treatment at 8 week |
Changes in waist circumference from baseline after 8 weeks of treatment. | Changes in waist circumference from baseline after 8 weeks of treatment. | From baseline to the end of treatment at 8 week |
Changes in waist-to-hip ratio from baseline after 8 weeks of treatment. | Changes in waist-to-hip ratio from baseline after 8 weeks of treatment. | From baseline to the end of treatment at 8 week |
Changes in fasting insulin from baseline after 8 weeks of treatment. | Changes in fasting insulin from baseline after 8 weeks of treatment. | From baseline to the end of treatment at 8 week |
Changes in fasting C-peptide from baseline after 8 weeks of treatment. | Changes in fasting C-peptide from baseline after 8 weeks of treatment. | From baseline to the end of treatment at 8 week |
Changes in HOMA-β from baseline after 8 weeks of treatment. | Changes in HOMA-β from baseline after 8 weeks of treatment. | From baseline to the end of treatment at 8 week |
Changes in HOMA-IR from baseline after 8 weeks of treatment. | Changes in HOMA-IR from baseline after 8 weeks of treatment. | From baseline to the end of treatment at 8 week |
Changes in lipid profile from baseline after 8 weeks of treatment. | Changes in lipid profile from baseline after 8 weeks of treatment. | 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. | From baseline to the end of treatment at 8 week |
Changes in heart rate from baseline after 8 weeks of treatment. | Changes in heart rate from baseline after 8 weeks of treatment. | 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. | From baseline to week 20 |
Proportion of subjects achieving HbA1c <7% at 20 weeks. | Proportion of subjects achieving HbA1c \<7% at 20 weeks. | 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. | From baseline to week 20 |
Changes in weight from baseline at 20 weeks. | Changes in weight from baseline at 20 weeks. | From baseline to week 20 |
Changes in BMI from baseline at 20 weeks. | Changes in BMI from baseline at 20 weeks. | From baseline to week 20 |
Changes in waist-to-hip ratio from baseline at 20 weeks. | Changes in waist-to-hip ratio from baseline at 20 weeks. | 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. | From baseline to week 20 |
Changes in postprandial blood glucose from baseline at 20 weeks. | Changes in postprandial blood glucose from baseline at 20 weeks. | From baseline to week 20 |
Changes in HbA1c from baseline at 20 weeks. | Changes in HbA1c from baseline at 20 weeks. | From baseline to week 20 |
Changes in HOMA-β from baseline at 20 weeks. | Changes in HOMA-β from baseline at 20 weeks. | From baseline to week 20 |
Changes in HOMA-IR from baseline at 20 weeks. | Changes in HOMA-IR from baseline at 20 weeks. | From baseline to week 20 |
Changes in fasting insulin from baseline at 20 weeks. | Changes in fasting insulin from baseline at 20 weeks. | From baseline to week 20 |
Changes in fasting C-peptide from baseline at 20 weeks. | Changes in fasting C-peptide from baseline at 20 weeks. | From baseline to week 20 |
Changes in lipid profile from baseline at 20 weeks. | Changes in lipid profile from baseline at 20 weeks. | From baseline to week 20 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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.
- Presence of other severe diseases that may interfere with the study, as judged by the investigator.
- Pregnant or breastfeeding women.
- Poor compliance, as judged by the investigator, and inability to complete the study as required.
- 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.
- Any other factors deemed unsuitable for participation in the study by the investigator.
Beijing HospitalStudy Central Contact
Contact: Lixin Guo, M.D.，Ph.D., +8613901317569, [email protected]
Contact: Dongni Yu, M.D., +8613621273587, [email protected]
16 Study Locations in 1 Countries
Beijing Municipality
Pinggu District Hospital, Beijing, Beijing Municipality, 000, China
Yufeng Li, M.D., Contact, +8613911080328, [email protected]
Recruiting
Capital Medical University Beijing Anzhen Hospital, Beijing, Beijing Municipality, China
Liping Ma, M.D., Contact, +8613901249835, [email protected]
Recruiting
Emergency General Hospital, Beijing, Beijing Municipality, China
Kailiang Wang, M.D., Contact, +8613911151692, [email protected]
Recruiting
Peking University Shougang Hospital, Beijing, Beijing Municipality, China
Xiuqin Sun, M.D., Contact, +8613552300467, [email protected]
Recruiting
Guangdong
Southern Medical University Nanfang Hospital, Guangzhou, Guangdong, 000, China
Yaoming Xue, M.D., Contact, +8613926066999, [email protected]
Recruiting
Heilongjiang
Harbin Medical University Second Hospital, Harbin, Heilongjiang, China
Qiao Hong, M.D., Contact, +8613359854888, [email protected]
Recruiting
Jiangsu
Southeast University Zhongda Hospital, Nanjing, Jiangsu, 000, China
Ling Li, M.D., Contact, +8613951606816, [email protected]
Recruiting
Xuzhou Medical University Affiliated Hospital, Xuzhou, Jiangsu, China
Hongwei Ling, M.D., Contact, +8618052268607, [email protected]
Recruiting
Jilin
China-Japan Union Hospital of Jilin University, Changchun, Jilin, China
Qing Wang, M.D., Contact, +8613614301117, [email protected]
Recruiting
Jilin University Second Hospital, Changchun, Jilin, China
Hanqing Cai, M.D., Contact, +8613674315050, [email protected]
Recruiting
Shaanxi
Xi'an Jiaotong University Second Hospital, Xi'an, Shaanxi, 000, China
Jing Xu, M.D., Contact, +8613772151682, [email protected]
Recruiting
Sichuan
Southwest Medical University Affiliated Hospital, Luzhou, Sichuan, 000, China
Xu Yong, M.D., Contact, +8613980255895, [email protected]
Recruiting
Tianjin Municipality
Peking University Binhai Hospital, Tianjin, Tianjin Municipality, China
Su Wang, M.D., Contact, +8615122328988, [email protected]
Recruiting
First Hospital of Peking University, Beijing, 100034, China
Geheng Yuan, Ph.D. M.D., Contact, 13811235488, [email protected]
Recruiting
Heilongjiang provincial hospital, Harbin, 150030, China
Binhong Duan, M.D, Ph.D., Contact
Recruiting
Henan People's Hospital, Zhengzhou, 450003, China
Huijuan Yuan, Ph.D. M.D., Contact
Recruiting