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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin degludec injection | Experimental | Insulin degludec injection subcutaneous administration once daily for 26 weeks in combination with Oral antidiabetic drugs (OADs) used before. |
|
| Tresiba® | Active Comparator | Insulin degludec injection(Tresiba®)subcutaneous administration once daily for 26 weeks in combination with Oral antidiabetic drugs (OADs) used before. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin degludec injection | Drug | long-acting insulin |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change value of glycosylated hemoglobin (HbA1c) | Change value of HbA1c from baseline following 26 weeks of therapy | Baseline and 26 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients achieving HbA1c ≤7% or HbA1c ≤6.5% | Percentage of patients in each arm achieving HbA1c ≤7% or HbA1c ≤6.5% after 26 weeks of treatment. | Baseline, week 26 |
| Change value of HbA1c |
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Inclusion Criteria:
Exclusion Criteria:
(1) HCV(hepatitis C virus) antibody is positive, and the HCV virus titer test value exceeds the upper limit of normal value; (2) HBsAg(Hepatitis B surface antigen) is positive and the HBV(hepatitis B virus) DNA test value exceeds the upper limit of normal; (3) HIV(human immunodeficiency virus) positive; (4) Active syphilis;
11. At the time of screening, there are thyroid diseases that have not been controlled with stable doses of drugs within 6 months, and the results of thyroid function tests during the screening period are abnormal and have clinical significance.
12. Uncontrolled or poorly treated high blood pressure.
13. Those with decompensated heart failure (NYHA class III and IV), unstable angina, stroke or transient ischemic attack, myocardial infarction, severe arrhythmia, cardiac surgery or blood vessel reconstruction (including coronary artery bypass grafting or percutaneous coronary intervention) occurred within 6 months before screening.
14. Those with proliferative retinopathy or macular degeneration (macular edema) that requires urgent treatment during screening.
15. Once diagnosed as malignant tumor (except for basal cell carcinoma or squamous cell skin cancer).
16. Patients with severe chronic gastrointestinal diseases (such as active peptic ulcer) and severe infections.
17. Those who are allergic to any ingredient in insulin deglu injection and Novota®.
18.Those who participated in any other clinical trials within 3 months before screening (excluding those who failed the screening or did not use study drugs for other reasons).
19. Pregnant women, lactating women, women of childbearing age who do not take appropriate contraceptive measures during the trial period (sterilization, intrauterine device, oral contraceptives or barrier contraception).
20. Those who are judged by the investigator to be unsuitable to participate in the trial.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhiguang Zhou, Doctor | Contact | 0731-85294018 | zhouzg@hotmail.com | |
| Qifu Li, Doctor | Contact | 023-89012755 | liqifu@yeah.net |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Chongqing Medical University | Recruiting | Chongqing | Chongqing Municipality | 400010 | China |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| C571886 | insulin degludec |
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| Tresiba® |
| Drug |
long-acting insulin |
|
Change value of HbA1c from baseline following 14 weeks of therapy
| Baseline, week 14 |
| Change value of fasting blood glucose | Change value of fasting blood glucose following 14 and 26 weeks of therapy | Baseline, week 14, week 26 |
| Adverse events (AEs) and serious adverse events (SAEs) | AEs and SAEs and their incidence during the 26-week treatment period, and then determine the correlation with the drug | Baseline to week 26 |
| Hypoglycemia | Frequency of severe or symptomatic hypoglycemia during the 26-week treatment period | Baseline to week 26 |
| Immunogenicity | The occurrence of immunogenicity during the 26-week treatment period by detecting Anti-Drug-Antibody(ADA). | Baseline, week 14, week 26 |
| Abnormal findings | Abnormal findings during the 26-week treatment period,including abnormal findings of blood routine test,blood biochemical test as well as other abnormal laboratory findings. | Baseline to week 26 |
| The Second Xiangya Hospital of Central South University | Recruiting | Changsha | Hunan | 410013 | China |
|
| D004700 | Endocrine System Diseases |