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
Status: Recruiting
Location: See all (16) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• 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.
Locations
Other Locations
China
Capital Medical University Beijing Anzhen Hospital
RECRUITING
Beijing
Emergency General Hospital
RECRUITING
Beijing
First Hospital of Peking University
RECRUITING
Beijing
Peking University Shougang Hospital
RECRUITING
Beijing
Pinggu District Hospital
RECRUITING
Beijing
China-Japan Union Hospital of Jilin University
RECRUITING
Changchun
Jilin University Second Hospital
RECRUITING
Changchun
Southern Medical University Nanfang Hospital
RECRUITING
Guangzhou
Harbin Medical University Second Hospital
RECRUITING
Harbin
Heilongjiang provincial hospital
RECRUITING
Harbin
Southwest Medical University Affiliated Hospital
RECRUITING
Luzhou
Southeast University Zhongda Hospital
RECRUITING
Nanjing
Peking University Binhai Hospital
RECRUITING
Tianjin
Xi'an Jiaotong University Second Hospital
RECRUITING
Xi'an
Xuzhou Medical University Affiliated Hospital
RECRUITING
Xuzhou
Henan People's Hospital
RECRUITING
Zhengzhou
Contact Information
Primary
Lixin Guo, M.D.,Ph.D.
glx1218@163.com
+8613901317569
Backup
Dongni Yu, M.D.
yudongni@outlook.com
+8613621273587
Time Frame
Start Date:2019-07-02
Estimated Completion Date:2025-12
Participants
Target number of participants:115
Treatments
Experimental: Continuous Beinaglutide infusion
8-week Beinaglutide (continuous subcutaneous infusion) treatment group