Status:
COMPLETED
A Trial Comparing the Efficacy and Safety of GZR4 Injection Versus Insulin Degludec in Subjects with Type 2 Diabetes Mellitus
Lead Sponsor:
Gan and Lee Pharmaceuticals, USA
Conditions:
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
This study compares the efficacy, safety, and tolerability of once-weekly GZR4 Injection versus once-daily insulin degludec in patients with type 2 diabetes mellitus in inadquete control on oral antid...
Eligibility Criteria
Inclusion
- Aged 18-75 years (both inclusive) at the time of signing informed consent form (ICF)
- Body mass index between 18.5 and 35.0 kg/m2 (both inclusive)
- Diagnosed with type 2 diabetes mellitus above or equal to 6 months
- 7.5% ≤ HbA1c ≤ 10.0% at screening.
Exclusion
- Female who is pregnant, breast-feeding.
- Presence or history of malignant neoplasm prior to screening.
- Diabetic ketoacidosis, diabetic lactic acidosis, or diabetic nonketotic hyperosmolar syndrome within 6 months 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.
- Participation in a clinical study of another study drug within 3 month prior to randomization.
Key Trial Info
Start Date :
August 11 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 8 2024
Estimated Enrollment :
179 Patients enrolled
Trial Details
Trial ID
NCT06202079
Start Date
August 11 2023
End Date
August 8 2024
Last Update
January 23 2025
Active Locations (8)
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1
Study Site 07
Wuhan, Hubei, China
2
Study Site 06
Changzhou, Jiangsu, China
3
Study Site 08
Jinan, Shandong, China
4
Study Site 04
Zibo, Shandong, China