A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM

Change in Fasting Plasma Glucose (FPG)

Change from baseline in fasting plasma glucose (FPG) after 16 weeks of treatment

Time frame: Baseline to Week 16

The total daily dose of GZR101 and Insulin Degludec/Insulin Aspart at Week 16

The total daily dose of GZR101 and the total daily dose of Insulin Degludec/Insulin Aspart at week 16 are presented.

Time frame: Week 16

Incidence and Rate of hypoglycemia Events

Hypoglycaemia alert value (level 1) was defined as episodes that were 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) were defined as episodes that were 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) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery. Severe hypoglycaemic episodes (level 3) were defined as episodes that were associated with severe cognitive impairment requiring external assistance for recovery.

Time frame: Baseline to Week 16

Incidence and Rate of Treatment-emergent AE/SAEs

A TEAE was defined as an event that had onset date (or increase in severity) during the on-treatment observation period.

Time frame: Baseline to Week 16