Compares GZR33 injection with insulin degludec in type 2 diabetes
Tests GZR33 injection against insulin degludec in adults with type 2 diabetes.
Plain-language title generated from the registry record
Registry title: Evaluate the Efficacy and Safety of GZR33 Injection in Patients With Type 2 Diabetes
Key facts
- Where
- Beijing, ChinaSee the site
- Phase
- Phase 3
Where in China
- Gan & Lee PharmaceuticalsBeijing, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Gan & Lee Pharmaceuticals.
- Trial code
- NCT07527078
- Record updated
- 1 July 2026
- Original description
Evaluate the efficacy of GZR33 Injection and Insulin Degludec Injection (Tresiba®) in Patients with Type 2 Diabetes Mellitus Inadequately Controlled with Oral Antidiabetic Drugs.Read full original descriptionShow less
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.
Inclusion: 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.
Exclusion: 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; History of severe cardiovascular and cerebrovascular diseases within 180 days prior to screening; Significant hepatic or renal dysfunction or active infectious diseases at screening; Any other conditions that, in the investigator's judgment, may compromise subject safety or interfere with trial conduct, progress, or outcome; 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); 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; Female subjects who are pregnant, lactating at screening, or planning a pregnancy during the trial period; 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.