Status:
RECRUITING
A Trial Comparing Efficacy, Tolerability, and Safety of GZR101 Injection Once Daily (OD) and GZR33-70 Injection OD
Lead Sponsor:
Gan and Lee Pharmaceuticals, USA
Conditions:
Type 2 Diabetes
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
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 bas...
Eligibility Criteria
Inclusion
- 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.
- At the age of 18-75 (inclusive) at the time of informed consent, male or female.
- Negative pregnancy test results for serum human chorionic gonadotropin (HCG) in women of childbearing potential at screening.
- Diagnosed with type 2 diabetes mellitus above or equal to 6 months.
Exclusion
- Presence or history of malignant neoplasm prior to screening.
- Known or suspected hypersensitivity to investigational medical product(s) or related products.
- Severe hypoglycemia (Level 3 hypoglycemia) within 6 months prior to screening.
- 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.
Key Trial Info
Start Date :
June 28 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2024
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06558708
Start Date
June 28 2024
End Date
December 1 2024
Last Update
August 19 2024
Active Locations (1)
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1
Study Site 01
Tianjin, China