This is a randomised, open-label, multicenter, active-controlled, parallel-design, phase III clinical trial. The purpose of this study to compare the efficacy and safety of Insulin Degludec/Liraglutide Injection with XULTOPHY® once daily via subcutaneous injection in Chinese Subjects with Type 2 Diabetes.
Subjects who voluntarily participate in this clinical trial and signed the informed consent form (ICF);
Chinese subjects aged 18-75 years (both inclusive) at the time of consent, male or female;
Type 2 diabetes mellitus (clinically diagnosed for more than 6 months);
HbA1c7.0-10.0 % (both inclusive) by central laboratory analysis at the time of screening;
Subjects with diabetes of other types than T2DM;
Known or suspected hypersensitivity to trial product(s) or related components;
Participated in any clinical trial and Receipt of any treatment of investigational medicinal product (IMP) or medical device within 90 days prior screening;
Treatment with glucose lowering agent(s) other than stated in the inclusion criteria 5 for cumulatively more than 14 days in a period of 90 days before screening; or treatment with these agent(s) in a period of 30 days before screening and might influence the assessment of efficacy of glycemic control (Judged by the investigator);
Parallel
Insulin Degludec/liraglutide Injection
DrugSubcutaneously (s.c., under the skin)administration once daily in combination with metformin. Dose was individually adjusted.
XULTOPHY®
DrugSubcutaneously (s.c., under the skin)administration once daily in combination with metformin. Dose was individually adjusted.
Change from baseline in HbA1c after 26 weeks of treatment
Calculated based on HbA1c level measured in plasma
Proportion of subjects that achieved HbA1c<7% after 12, 26 weeks of treatment
Calculated based on HbA1c level measured in plasma
Proportion of subjects that achieved HbA 1c ≤ 6.5% after 12, 26 weeks of treatment
Calculated based on HbA1c level measured in plasma
Changes from baseline in fasting plasma glucose (FPG) after 12, 26 weeks of treatment
Calculated based on FPG level measured in plasma
Change from baseline in 7-point SMBG values after 12, 26 weeks of treatment
Calculated based on 7-point SMBG values
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This trial is not recruiting at the moment. You can still explore other options:
