A Multicenter, Randomized, Open-label, Parallel-controlled Phase III Clinical Study to Compare the Efficacy and Safety of Insulin Degludec Injection Versus Tresiba® in Subjects With Type 2 Diabetes
Who is this study for? Patients with type 2 diabetes
What treatments are being studied? Insulin degludec
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
This study is a multi-center, randomized, open-label, parallel, positive-controlled registered clinical study,to evaluate the efficacy and safety of insulin degludec injection developed by Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 70
Healthy Volunteers: f
View:
• Type 2 diabetes (diagnosed clinically) for at least 6 months.
• Aged ≥18 and ≤70 years old, male or female.
• Subjects who were treated with a stable dose of oral hypoglycemic agents for more than 3 months before the random visit.
• HbA1c is in the range of 7.5% -11.0 % by local laboratory analysis.
• Body mass index (BMI) ≥18 kg/m2 and ≤40kg/m2.
• Patients must give informed consent to this study before the trial, and voluntarily sign an informed consent form.
• Patients who can communicate well with the investigator and can complete the study in accordance with the research regulations.
Locations
Other Locations
China
The Second Xiangya Hospital of Central South University
RECRUITING
Changsha
The First Affiliated Hospital of Chongqing Medical University
RECRUITING
Chongqing
Contact Information
Primary
Zhiguang Zhou, Doctor
zhouzg@hotmail.com
0731-85294018
Backup
Qifu Li, Doctor
liqifu@yeah.net
023-89012755
Time Frame
Start Date:2021-07-27
Estimated Completion Date:2025-12-31
Participants
Target number of participants:344
Treatments
Experimental: Insulin degludec injection
Insulin degludec injection subcutaneous administration once daily for 26 weeks in combination with Oral antidiabetic drugs (OADs) used before.
Active_comparator: Tresiba®
Insulin degludec injection（Tresiba®）subcutaneous administration once daily for 26 weeks in combination with Oral antidiabetic drugs (OADs) used before.