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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Study Site 01
Tianjin, China
RECRUITINGChange in HbA1c
Change from baseline in HbA1c (Glycosylated Haemoglobin) after 16 weeks of treatment
Time frame: Week 0, week 16
Change in Fasting Plasma Glucose (FPG)
Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment
Time frame: Week 0, Week 16
Change in 7-point SMPG profile
Change from baseline in 7-point SMPG profile after 16 weeks of treatment: the mean and the CV
Time frame: Week 0, Week 16
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.
Time frame: Week 0, Week 19
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.
Time frame: Week 0, Week 19
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