Diabetes
Conditions
Interventions
HS005: Type I diabetes:Type 1 diabetes: Glargine Insulin+ NovoRapid, HS005+ Glargine Insulin
NovoRapid: Type I diabetes:Type1 diabetes: Glargine Insulin+ NovoRapid, NovoRapid + Glargine Insulin
HS005: Type II diabetes:Type II diabetes Glargine Insulin+Metformin Hydrochloride Tablets, HS005+ Glargine Insulin+Metformin Hydrochloride Tablets
NovoRapid: Type II diabetes:Type II diabetes Glargine Insulin+Metformin Hydrochloride Tablets, NovoRapid + Glargine Insulin+Metformin Hydrochloride Tablets
Sponsors
Nanjing Drum Tower hospital (the Affiliated Hospital of Nanjing University Medical School)
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 ~ 75 years old male and female; 2. BMI 18 to 35 kg/M2; 3. Subjects with Type 1 or type 2 diabetes diagnosed according to WHO Standard (1999); 4. Subjects with Type 1 diabetes were treated with insulin and / or its analogues for more than 3 months prior to screening; subjects with Type 2 diabetes met at least one of the following conditions; (1) patients were treated with insulin andor analogues for more than 3 months prior to screening; (2) patients were treated with more than 2 oral hypoglycemic agents for more than 3 months prior to screening, all of which contained at least one insulin secreting agent (Sulfonylurea, Glenide Andor Dipeptidyl peptidase-4 inhibitor)(at least half of the maximum dose recommended in the instructions) , which was not well controlled; 5. Glycated hemoglobin 7.0 to 13.0%; 6. willing to sign an informed consent.
Exclusion criteria
Exclusion criteria: 1. Persons with a history of drug abuse, or alcoholics or those who had consumed alcohol regularly during the three months prior to the trial, i.e. drinking more than 14 units of alcohol per week (14 bottles of 360 mL beer or 630 mL of spirits with 40% alcohol content or 2100 mL of wine); 2. Allergic to any of the ingredients (including insulin, Insulin analog and its preparations, E. Coli and yeast products) of the drug under test; 3. History of malignant tumor; 4. People with other specific types of diabetes, such as Insulin Synthesis disorders due to pancreatic disease; 5. Any blood disease (E. G. hemolytic anemia, sickle cell disease) that may affect HbA1c measurements during screening; 6. In the 3 months prior to screening, hypoglycemic comas that the researchers considered unsuitable for participation in this study appeared; 7. Patients with known proliferative retinopathy or macular degeneration requiring urgent treatment; 8. Severe active peripheral vascular disease (such as claudication with minimal mobility, non-healing ischemic ulcers, or possible need for bypass or Angioplasty intervention) is present; 9. Untreated hypertension or uncontrolled by treatment (systolic blood pressure >=160 mm hg or diastolic blood pressure >=100 mm Hg); 10. Acute myocardial infarction occurred within 3 months prior to screening, or uncontrolled angina, uncontrolled. 11. People with severe lung disease or a history of Hypoxia, or in a state of emergency (such as surgery, acute head injury, etc.); 12. Patients who had used immunomodulator, cytotoxic drugs and systemic glucocorticoid accumulated more than 7 days within 3 months before screening; 13. Skin diseases affecting subcutaneous injection, or serious bleeding factors affecting venous blood collection; 14. Pregnancy, persons planning to become pregnant during the trial, persons who are breastfeeding, or persons of childbearing age who have not taken adequate contraceptive measures (adequate means oral contraceptives, Intrauterine device or barrier measures); 15. Three months prior to screening, participants in other clinical trials; 16. 2.5 x normal value upper limit, 2.5 x normal value upper limit, 2.5 x normal value upper limit, 1.5 x normal value upper limit, 1.5 x normal value upper limit, or serum creatinine (CR) >1.0 x normal value upper limit; Or Female Hemoglobin <=110G/L, or male Hemoglobin <=120G/L; 17. The researchers judged the group unsuitable (including night shift workers, significant lifestyle changes, dietary variability, and other diseases that affected the study).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| After 24 weeks of treatment, HBALC relative baseline changes were observed in HS005 group compared with those in NovoRapid group; | — |
Countries
China
Contacts
Public ContactDalong Zhu
Nanjing Drum Tower hospital (the Affiliated Hospital of Nanjing University)
Outcome results
None listed