Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin Degludec/liraglutide injection | Experimental | Subcutaneously (s.c., under the skin) administration once daily in combination with metformin. Dose was individually adjusted. |
|
| XULTOPHY® | Active Comparator | Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. Dose was individually adjusted. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Degludec/liraglutide Injection | Drug | Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. Dose was individually adjusted. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in HbA1c after 26 weeks of treatment | Calculated based on HbA1c level measured in plasma | Baseline, Week 26 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of subjects that achieved HbA1c<7% after 12, 26 weeks of treatment | Calculated based on HbA1c level measured in plasma | Week 12, Week 26 |
| Proportion of subjects that achieved HbA 1c ≤ 6.5% after 12, 26 weeks of treatment |
Not provided
Inclusion Criteria:
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;
Current treatment for at least 90 calendar days prior to screening with metformin monotherapy or metformin in any combination with 1 additional OADs (including fixed combination): SU, glinides, AGI, SGLT2i or TZD. For ≥ 60 calendar days prior to screening subjects should be on a stable dose of:
Body mass index (BMI) ≥ 19.0 kg/m2 and ≤ 40 kg/m2;
Able and willing to adhere to the protocol including performing self-monitoring of plasma glucose profiles, keeping a trial diary and using a pre-filled pen device.
Exclusion Criteria:
Subjects who meet any of the following criteria will be excluded from the study:
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000613158 | IDegLira |
| C000629636 | Xultophy |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| XULTOPHY® | Drug | Subcutaneously (s.c., under the skin)administration once daily in combination with metformin. Dose was individually adjusted. |
|
Calculated based on HbA1c level measured in plasma
| Week 12, Week 26 |
| Changes from baseline in fasting plasma glucose (FPG) after 12, 26 weeks of treatment | Calculated based on FPG level measured in plasma | Baseline, Week 12, Week 26 |
| Change from baseline in 7-point SMBG values after 12, 26 weeks of treatment | Calculated based on 7-point SMBG values | Baseline, Week 12, Week 26 |
| Change from baseline in body weight after 12, 26 weeks of treatment | Calculated based on body weight measurement | Baseline, Week 12, Week 26 |
| Number of treatment emergent adverse events | Count | From Baseline to Week 27 |
| Number of treatment emergent hypoglycaemic episodes | Count | From Baseline to Week 27 |
| Number of participants with injection site reactions | Count (spontaneous pain, tenderness, itching, redness, edema, induration/infiltration) | From Baseline to Week 27 |
| Incidence of anti-drug antibodies (ADA), and neutralising antibodies (if applicable) | Calculated based on the values of anti-drug antibodies (ADA), and neutralising antibodies (if applicable) | Baseline, Week 12, 26, and 27 (if applicable) |
| Plasma concentrations of degludec, liraglutide | Calculated based on plasma concentrations of degludec, liraglutide | Baseline, Week 2, 6, 12, 20, 26 |
| D004700 | Endocrine System Diseases |