Type 2 diabetes
Conditions
Interventions
Test group:IDegAsp BID
Control Group:IDegAsp QD+2IAsp
Sponsors
Beijing Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Informed consent has been obtained before any trial-related activities; 2. Patients aged 18~75 years old (including 18 years old and 75 years old); 3. Clinical diagnosis of type 2 diabetes >= 6 months according to WHO diagnostic criteria before screening; 4. Use basal insulin once a day with or without other hypoglycemic drugs for at least 3 months before randomization; 5. Glycated hemoglobin between 7.0%~10.0% (including the critical value); 6. Body mass index (BMI)<=40.0kg/m^2;
Exclusion criteria
Exclusion criteria: 1. Suffering from type 1 diabetes, or special type of diabetes; 2. Previously used premixed insulin or IDegAsp; 3. Changes in concomitant medications that are expected to significantly interfere with glucose metabolism, such as systemic corticosteroids, beta-blockers, and monoamine oxidase (MAO) inhibitors; 4. Known or suspected subjects are allergic to test drugs, excipients or related similar products and excipients; 5. Cardiovascular and cerebrovascular disease, defined as: congestive heart failure (NYHA class III-IV), diagnosis of unstable angina pectoris, stroke and/or myocardial infarction within 6 months before screening; or planned/coronary artery, carotid artery, peripheral artery revascularization; 6. According to the judgment of the investigator, repeated hypoglycemia perception impairment and severe hypoglycemia events occurred before screening; 7. Abnormal and clinically significant hemoglobin laboratory test results; 8. Hepatic insufficiency, defined as alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >= 2.5 times the upper limit of the normal range at screening; renal insufficiency, defined as (but not limited to) serum creatinine Levels >=1.5mg/dL (132umol/L, men) and >=1.4mg/dL (123umol/L, women), or massive proteinuria (>2 g/day); 9. Uncontrolled/untreated hypertension (systolic blood pressure >=160mmHg or diastolic blood pressure >=100mmHg) before randomization; 10. Two or more events of ketoacidosis or hyperglycemia and hyperosmolar state requiring hospitalization within 6 months prior to screening, or significant diabetic complications, such as symptomatic autonomic neuropathy, diabetic gastric mildew paralysis, proliferative retinopathy, etc. occured; 11. According to the judgment of the investigator, significant changes in lifestyle are expected during the trial period, such as shift work (including persistent night/evening shift work) and highly irregular diet and living habits; 12. Pregnant or breastfeeding women; those who have a pregnancy plan during the entire trial period and are unwilling to take one or more non-drug contraceptive measures (such as complete abstinence, contraceptive ring, partner ligation, etc.) during the trial; 13. Participate in any clinical trial within the past 3 months; 14. Those who are not suitable to participate in the trial according to the investigator's judgment, or any clinically significant disease or condition that the investigator believes may affect the results of the trial, such as: a history of hemolytic anemia or sickle cell anemia, a previous history of tumor or cancer Patients with a medical history, patients with a known history of alcohol, drug or drug abuse, blood transfusions or severe blood loss within the first 3 months of screening, or patients with poor adherence in the judgment of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in HbA1c (%) after 16 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| Percentage of patients with HbA1c < 7.0% in patients without definite hypoglycemia after 16 weeks of treatment;Body weight change from baseline after 16 weeks of treatment;Change from baseline in fasting blood glucose after 16 weeks of treatment;Change from baseline in 7-point self-monitoring blood glucose profile after 16 weeks of treatment;Change from Baseline in Mean Glucose and Glucose Variability (Coefficient of Variation) in CGM at Weeks 14-16 of Treatment;Change from Baseline in Percentage of Readings and Time in Target Range for Blood Glucose Values at Weeks 14-16 of Treatment;Change from baseline in percent of readings and time with blood glucose values below target range at 14-16 weeks of treatment;Change from baseline in percent of readings and time with blood glucose values above target range at 14-16 weeks of treatment;Change from Baseline in Glucose Management Indicators (GMI) at Weeks 14-16 of Treatment; | — |
Countries
China
Contacts
Public ContactGuo Lixin
Outcome results
None listed