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

A Phase II Trial Comparing Efficacy and Safety of GZR101 and Insulin Degludec/Insulin Aspart in Type 2 Diabetes Inadequately Controlled on Oral Antidiabetic Drug (OAD) Therapy or OAD Therapy in Combination with Insulin

This trial is conducted in China. The aim of the trial is to compare the efficacy and safety of GZR101 and insulin degludec/insulin aspart in insulin naïve or insulin treated subjects with type 2 diabetes.

Inclusion Criteria:

• Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
• BMI = 18.5-35 kg/m2 (inclusive) at screening.
• Diagnosed with type 2 diabetes mellitus for ≥ 6 months.
• 7.0% ≤ HbA1c ≤ 11.0% at screening.

Exclusion Criteria:

• Women in pregnancy or lactation.
• Subjects with any malignancy diagnosed prior to screening or documented history of malignancy.
• Those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma.
• Subjects experiencing serious hypoglycaemic events (Level 3 hypoglycaemia) within 3 months prior to screening.
• Subjects with with history of acute heart failure or having been hospitalized for coronary heart disease, myocardial infarction, unstable angina, or stroke within 6 months prior to screening.
• Known or suspected hypersensitivity to trial product(s).
• Participation in a clinical study of another study drug within 1 month prior to randomization.