Clinical trial NCT03987308: Comparing the Efficacy and Safety Between Continuous Subcutaneous Beinaglutide and CSII for Newly Diagnosed T2DM Patients
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetic Patients
T2DM (Type 2 Diabetes Mellitus)
T2DM
Keywords: T2DM
beinaglutide
CSII
subcutaneous pump
Lead sponsor: Beijing Hospital
Sponsor class: OTHER_GOV
First posted: 2019-06-17
Enrollment: 115
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 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.

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.

Primary outcomes:
measure: 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.
timeFrame: From baseline to the end of treatment at 8 week
Secondary outcomes:
measure: Proportion of subjects achieving HbA1c reduction <7% after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Changes in fasting blood glucose from baseline after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Changes in postprandial blood glucose from baseline after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Changes in HbA1C from baseline after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Proportion of subjects with weight reduction ≥5% from baseline after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Changes in weight from baseline after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Changes in waist circumference from baseline after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Changes in waist-to-hip ratio from baseline after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Changes in fasting insulin from baseline after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Changes in fasting C-peptide from baseline after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Changes in HOMA-β from baseline after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Changes in HOMA-IR from baseline after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Changes in lipid profile from baseline after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Changes in blood pressure baseline after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Changes in heart rate from baseline after 8 weeks of treatment.
timeFrame: From baseline to the end of treatment at 8 week
measure: Proportion of subjects achieving HbA1c <6.5% at 20 weeks.
timeFrame: From baseline to week 20
measure: Proportion of subjects achieving HbA1c <7% at 20 weeks.
timeFrame: From baseline to week 20
measure: Proportion of subjects with fasting blood glucose <7.0 mmol/L at 20 weeks.
timeFrame: From baseline to week 20
measure: Changes in weight from baseline at 20 weeks.
timeFrame: From baseline to week 20
measure: Changes in BMI from baseline at 20 weeks.
timeFrame: From baseline to week 20
measure: Changes in waist-to-hip ratio from baseline at 20 weeks.
timeFrame: From baseline to week 20
measure: Changes in fasting blood glucose from baseline at 20 weeks.
timeFrame: From baseline to week 20
measure: Changes in postprandial blood glucose from baseline at 20 weeks.
timeFrame: From baseline to week 20
measure: Changes in HbA1c from baseline at 20 weeks.
timeFrame: From baseline to week 20
measure: Changes in HOMA-β from baseline at 20 weeks.
timeFrame: From baseline to week 20
measure: Changes in HOMA-IR from baseline at 20 weeks.
timeFrame: From baseline to week 20
measure: Changes in fasting insulin from baseline at 20 weeks.
timeFrame: From baseline to week 20
measure: Changes in fasting C-peptide from baseline at 20 weeks.
timeFrame: From baseline to week 20
measure: Changes in lipid profile from baseline at 20 weeks.
timeFrame: From baseline to week 20
Other outcomes:
Locations:
city: Beijing
country: China
facility: Pinggu District Hospital
state: Beijing
city: Beijing
country: China
facility: Capital Medical University Beijing Anzhen Hospital
state: Beijing
city: Beijing
country: China
facility: Emergency General Hospital
state: Beijing
city: Beijing
country: China
facility: Peking University Shougang Hospital
state: Beijing
city: Guangzhou
country: China
facility: Southern Medical University Nanfang Hospital
state: Guangdong
city: Harbin
country: China
facility: Harbin Medical University Second Hospital
state: Heilongjiang
city: Nanjing
country: China
facility: Southeast University Zhongda Hospital
state: Jiangsu
city: Xuzhou
country: China
facility: Xuzhou Medical University Affiliated Hospital
state: Jiangsu
city: Changchun
country: China
facility: China-Japan Union Hospital of Jilin University
state: Jilin
city: Changchun
country: China
facility: Jilin University Second Hospital
state: Jilin
city: Xian
country: China
facility: Xi'an Jiaotong University Second Hospital
state: Shaanxi
city: Luzhou
country: China
facility: Southwest Medical University Affiliated Hospital
state: Sichuan
city: Tianjin
country: China
facility: Peking University Binhai Hospital
state: Tianjin
city: Beijing
country: China
facility: First Hospital of Peking University
city: Harbin
country: China
facility: Heilongjiang provincial hospital
city: Zhengzhou
country: China
facility: Henan People's Hospital
Study officials:
References: