A Randomized, Open-label, Parallel-controlled, Multicenter Phase III Clinical Study Comparing the Efficacy and Safety of GZR33 Injection and Insulin Degludec Injection in Patients With Type 2 Diabetes Mellitus Inadequately Controlled With Oral Antidiabetic Drugs
Evaluate the efficacy of GZR33 Injection and Insulin Degludec Injection (Tresiba®) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Oral Antidiabetic Drugs.
• Subjects sign the Informed Consent Form (ICF) before the study, fully understand the contents, process and possible adverse reactions of the study, and are able to follow the contraindications and restrictions specified in this protocol.
• Male or female, aged ≥18 years at the time of informed consent..
• Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at screening.
• According to the diagnostic criteria and classification of diabetes mellitus issued by the World Health Organization (WHO) in 1999, and the supplementary diagnostic criteria recommended by WHO for diagnosis with Hemoglobin A1c (HbA1c) (2011), the time to diagnose T2DM is ≥ 180 days at screening.
• Stable treatment with oral antidiabetic drugs for ≥ 90 days prior to screening.