A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD

Gan and Lee Pharmaceuticals

Status and phase: Enrolling; Phase 2

Conditions: Type 2 Diabetes

Treatments: Drug: Insulin aspart; Drug: GZR33 Injection; Drug: GZR101 Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06558708

GZR101-T2D-202

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 1. Signed the informed consent form (ICF) before the trial, fully understanding the trial content, process and possible adverse reactions, and being able to comply with the contraindications and restrictions specified in this protocol.
• 2.At the age of 18-75 (inclusive) at the time of informed consent, male or female.
• 3.Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening.
• 4.Diagnosed with type 2 diabetes mellitus above or equal to 6 months.

Exclusion criteria

• 1.Presence or history of malignant neoplasm prior to screening.
• 2.Known or suspected hypersensitivity to investigational medical product(s) or related products.
• 3.Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening.
• 4.History of acute heart failure within 6 months prior to screening or hospitalization for coronary heart disease, myocardial infarction, unstable angina, stroke within 6 months prior to screening.
• 5. Participated in another interventional clinical study within 4 weeks prior to randomization.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

GZR101 Injection

Experimental group

Description:

Participants will receive once daily GZR101 Injection with or without pre-dinner meal-time insulin, s.c, treat-to-target dose

Treatment:

Drug: GZR101 Injection

GZR33-70 Injection

Experimental group

Description:

Participants will receive once daily GZR33-70 Injection with or without pre-dinner meal-time insulin, s.c., treat-to-target dose

Treatment:

Drug: Insulin aspart

Drug: GZR33 Injection