Evaluate the Efficacy and Safety of GZR33 Injection in Patients With Type 2 Diabetes

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Type 2 Diabetes (T2DM)
• Intervention / Treatment: Drug: GZR33 Injection; Drug: Insulin Degludec Injection (Tresiba®)

Detailed Description

This study will be conducted to evaluate the efficacy of once-daily GZR33 Injection and once-daily Insulin Degludec Injection (Tresiba®) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Oral Antidiabetic Drugs.

• Study Type: Interventional
• Enrollment (Estimated): 350
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yuchi Liu; Phone Number: 010-8059-5000; Email: yuchi.liu@ganlee.com

Study Locations

• China
  • Beijing, China
    • Gan & Lee Pharmaceuticals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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.
2. Male or female, aged ≥18 years at the time of informed consent..
3. Body mass index (BMI) ≥18.5 and ≤35.0 kg/m2 at screening.
4. 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.
5. Stable treatment with oral antidiabetic drugs for ≥ 90 days prior to screening.

Exclusion Criteria:

1. History of hypersensitivity to ≥ 2 drugs with distinct mechanisms of action, or known hypersensitivity, allergic reactions, or intolerance to the investigational medicinal products or their excipients (glycerol, phenol, metacresol, zinc acetate dihydrate, sodium chloride, hydrochloric acid, sodium hydroxide).
2. Female subjects who are pregnant, lactating at screening, or planning a pregnancy during the trial period.
3. Confirmed or suspected type 1 diabetes mellitus or specific types of diabetes due to other causes (monogenic diabetes syndrome, cystic fibrosis-related diabetes, pancreatitis-induced diabetes, drug- or chemical-induced diabetes, etc.) prior to screening.
4. Presence of any diseases that may affect HbA1c testing at screening, such as hemolytic anemia, aplastic anemia, hemoglobinopathy, etc., and in the investigator's judgment unsuitable for participation; or blood donation, blood loss > 400 mL, or blood transfusion within 90 days prior to screening.
5. History of severe cardiovascular and cerebrovascular diseases within 180 days prior to screening.
6. Significant hepatic or renal dysfunction or active infectious diseases at screening.
7. Lifestyle (diet, exercise, work circadian rhythm, etc.) expected to change significantly during the trial and affect glycemic control; irregular three-meal intake (e.g., habitual skipping of breakfast); or unwillingness to comply with relevant lifestyle restrictions during the trial.
8. Any other conditions that, in the investigator's judgment, may compromise subject safety or interfere with trial conduct, progress, or outcome.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: GZR33 Injection	Drug: GZR33 Injection; GZR33 Injection Administered SC, once-daily
Active Comparator: Insulin Degludec Injection (Tresiba®)	Drug: Insulin Degludec Injection (Tresiba®); Administered SC, once-daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in Hemoglobin A1c (HbA1c) from baseline after 26 weeks of treatment.	Baseline , 26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in fasting plasma glucose (FPG) from baseline after 26 weeks of treatment	Baseline , 26 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Safety Endpoints	Number of adverse events (AEs) and serious adverse events (SAEs), and number and percent	Baseline , 27 weeks

Collaborators and Investigators

• Sponsor: Gan & Lee Pharmaceuticals.

Study record dates

Study Major Dates

• Study Start (Estimated): April 7, 2026
• Primary Completion (Estimated): April 10, 2027
• Study Completion (Estimated): April 17, 2027

Study Registration Dates

• First Submitted: April 8, 2026
• First Submitted That Met QC Criteria: April 8, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2; insulin degludec
• Other Study ID Numbers: GZR33-T2D-301

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No