Status:
COMPLETED
A Trial Comparing Efficacy and Safety of GZR101 and IDegAsp in Insulin Naïve or Insulin Treated Subjects with T2DM
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 and safety of GZR101 and insulin degludec/insulin aspart in insulin naïve or insulin treated subjects with type 2 diab...
Eligibility Criteria
Inclusion
- Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
- BMI = 18.5-35 kg/m2 (inclusive) at screening.
- Diagnosed with type 2 diabetes mellitus for ≥ 6 months.
- 0% ≤ HbA1c ≤ 11.0% at screening.
Exclusion
- Women in pregnancy or lactation.
- Subjects with any malignancy diagnosed prior to screening or documented history of malignancy.
- Those with the following diseases within 6 months prior to screening: diabetic ketoacidosis, diabetic lactic acidosis, or hyperosmolar nonketotic diabetic coma.
- Subjects experiencing serious hypoglycaemic events (Level 3 hypoglycaemia) within 3 months prior to screening.
- Subjects with with history of acute heart failure or having been hospitalized for coronary heart disease, myocardial infarction, unstable angina, or stroke within 6 months prior to screening.
- Known or suspected hypersensitivity to trial product(s).
- Participation in a clinical study of another study drug within 1 month prior to randomization.
Key Trial Info
Start Date :
November 21 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 12 2024
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT06199505
Start Date
November 21 2023
End Date
July 12 2024
Last Update
January 17 2025
Active Locations (1)
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1
Gan & Lee Pharmaceuticals Co., Ltd
Beijing, Beijing Municipality, China, 100000