GZR33 Injection plus Insulin Degludec for Type 2 Diabetes in Need of More Control

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 3 interventional trial explores the safety and efficacy of once-daily GZR33 injections in combination with once-daily Insulin Degludec (Tresiba) in adults with type 2 diabetes not well controlled on oral antidiabetic drugs. Eligible participants are adults 18 years or older with BMI 18.5–35 kg/m2 who have had T2DM for at least 180 days and stable oral therapy for at least 90 days. The study will monitor glycemic outcomes and safety over a defined treatment period. Exclusion criteria include a history of hypersensitivity to study drugs or related components. The lead sponsor is Gan & Lee Pharmaceuticals, based in Beijing, with no listed collaborators.

Why it matters

Who can join: the full rules

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.

Where it's running

• Gan & Lee Pharmaceuticals
  Beijing, China Recruiting

Study contacts

• Study coordinator: Yuchi Liu
• Email: yuchi.liu@ganlee.com
• Phone: 010-8059-5000

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.