This trial is conducted in China. The aim of the trial is to compare the efficacy, tolerability, and safety of GZR101 Injection and GZR33-70 Injection in type 2 diabetes inadequately controlled on basal/ premixed insulin once daily at least with or without pre-dinner meal-time insulin.
1. Signed the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
2.At the age of 18-75 (inclusive) at the time of informed consent, male or female.
3.Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening.
4.Diagnosed with type 2 diabetes mellitus above or equal to 6 months.
1.Presence or history of malignant neoplasm prior to screening.
2.Known or suspected hypersensitivity to investigational medical product(s) or related products.
3.Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening.
4.History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening.
Parallel
GZR101 Injection
DrugOnce daily
GZR33 Injection
DrugOnce daily
Insulin aspart
DrugOnce daily
Change in HbA1c
Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment
Change in Fasting Plasma Glucose (FPG)
Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment
Change in 7-point SMPG profile
Change from baseline in 7-point SMPG profile after 16 weeks of treatment: the mean and the CV
Incidence and Rate of Treatment-emergent AE/SAEs
A TEAE is defined as an event that had onset date (or increase in severity) during the on-treatment observation period.
Incidence and Rate of hypoglycemia Events
Hypoglycaemia alert episodes (level 1) are defined as episodes that are sufficiently low for treatment with fast-acting carbohydrate and dose adjustment of glucose-lowering therapy with plasma glucose value of equal to or above (\>=) 3.0 and less than (\<) 3.9 mmol/L (\>= 54 and \< 70 mg/dL) confirmed by BG meter. Clinically significant hypoglycaemic episodes (level 2) are defined as episodes that are sufficiently low to indicate serious, clinically important hypoglycaemia with plasma glucose value of less than (\<) 3.0 mmol/L (54 mg/dL). Severe hypoglycaemic episodes (level 3) are defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Severe hypoglycaemic episodes (level 3) are defined as episodes that are associated with severe cognitive impairment requiring external assistance for recovery.
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