A Phase III Clinical Study to Assess the Efficacy and Safety of GZR4 in Type 2 Diabetes Mellitus Subjects (T2DM) Treated With Basal + Prandial Insulin

Inclusion Criteria:

• Sign the Informed Consent Form (ICF) before the study, fully understand thecontents, process and possible adverse reactions of the study, and be able to followthe contraindications and restrictions specified in this protocol.

• Males and females age ≥ 18 years at the time of informed consent.

• The pregnancy test for β-human chorionic gonadotropin (hCG) must be negative forwomen of childbearing potential during the screening period and prior torandomization.

• From signing the Informed Consent Form until 3 weeks after the end of treatment,female subjects of childbearing potential and male subjects and their partners mustagree to use reliable contraceptive measures and not donate eggs (ova, oocytes) orsperm for assisted reproductive purposes.

• According to the diagnostic criteria and classification of diabetes mellitus issuedby the World Health Organization (WHO) in 1999, and the supplementary diagnosticcriteria recommended by WHO for diagnosis with Hemoglobin A1c (HbA1c) (2011), thetime to diagnose T2DM is ≥ 180 days at screening.

• Prior to screening, one basal insulin once daily and prandial insulin 2 ~ 4 timesdaily was given. Or 1 or 2 times daily of a premixed insulin analogue or dualinsulin analogue.

Exclusion Criteria:

• A history of allergy to drugs with two or more mechanisms of action in the past, orknown allergies, hypersensitivity, or intolerance to the investigational medicinalproduct or its excipients (glycerol, phenol, m-cresol, zinc acetate dihydrate,sodium chloride, citric acid monohydrate, or zinc chloride).

• Subjects who are pregnant, lactating or planning to become pregnant during the studyat screening.

• Participated in any drug clinical study (received non-placebo medication during thestudy) within a recent period of time (90 days or 5 half-lives of the previousinvestigational medicinal product, whichever is longer), or plans to participate inanother clinical study before completing all scheduled assessments in this clinicalstudy.

• Underwent invasive cardiovascular or cerebrovascular procedures within 180 daysbefore screening; or experienced acute heart failure, myocardial infarction, stroke,or hospitalization due to angina unstable, transient ischaemic attack, or otheracute cardiovascular events within 180 days before screening; or have a history ofchronic cardiac failure classified as New York Heart Association Class III or IV atscreening; or plan to undergo coronary, carotid, or peripheral arterialrevascularisation procedures during the study; or have clinically significantabnormalities on the electrocardiogram (ECG) that require treatment at screening (such as second-degree type II or third-degree atrioventricular block, ventricularfibrillation, ventricular flutter, atrial fibrillation, atrial flutter,Wolff-Parkinson-White syndrome, etc.).

• History of malignant tumors before screening (excluding adequately treated orresected non-metastatic basal or squamous cell skin cancer, cervical carcinoma insitu, or prostate cancer in situ) or the presence of underlying malignancy atscreening.

• The patient with SBP ≥ 160 mmHg or DBP ≥ 100 mmHg during screening.

• Subjects who are unable to comply with the requirements of this protocol as judgedby the investigator, or have any other conditions that the investigator considersinappropriate to participate in this study.