Actively Recruiting
A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin
Led by Gan & Lee Pharmaceuticals. · Updated on 2025-11-25
300
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study will be conducted to compare the efficacy, safety and patient-reported outcome of GZR4 and Insulin Icodec with or without Non-Insulin Antidiabetic Agents in subjects with Type 2 Diabetes Mellitus (T2DM) treated with basal insulin.
CONDITIONS
Official Title
A Phase IIIb Clinical Study to Assess the Efficacy and Safety of GZR4 in Subjects With Type 2 Diabetes Mellitus Treated With Basal Insulin
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and able to follow study rules
- Male or female aged 18 years or older
- Negative pregnancy test for women of childbearing potential at screening and before randomization
- Agree to use reliable contraception during the study and for 3 weeks after treatment if applicable
- Diagnosed with Type 2 Diabetes Mellitus for at least 180 days
- Treated with basal insulin once or twice daily or once-weekly Insulin Icodec before screening
You will not qualify if you...
- History of allergy to drugs with two or more mechanisms of action or known allergies to the study drug or its ingredients
- Pregnant, breastfeeding, or planning pregnancy during the study
- Participated in another drug study with active medication within 90 days or 5 half-lives before screening, or plans to join another study before finishing this one
- Had invasive cardiovascular or cerebrovascular procedures within 180 days before screening
- Experienced acute heart failure, heart attack, stroke, unstable angina, or other acute cardiovascular events within 180 days before screening
- Chronic heart failure classified as New York Heart Association Class III or IV at screening
- Planned coronary, carotid, or peripheral arterial revascularisation during the study
- Significant ECG abnormalities considered inappropriate by the investigator
- History of malignant tumors within 5 years before screening except adequately treated non-metastatic skin or in situ cancers
- Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg at screening
- Unable to comply with protocol requirements or other conditions judged inappropriate by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Gan & Lee Pharmaceuticals Shandong Co., Ltd.
Linyi, Shandong, China, 276000
Actively Recruiting
Research Team
J
juan wu
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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