This study will be conducted to evaluate the efficacy and safety of GZR101-80 Injection in patients with type 2 diabetes mellitus inadequately controlled on oral antidiabetic drugs or Basal/Premixed Insulin.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
300
Administered SC
Administered SC
Gan & Lee Pharmaceuticals
Beijing, China
Change in Hemoglobin A1c (HbA1c) from baseline after 16 weeks of treatment.
Time frame: Baseline , 16 weeks
Change in fasting plasma glucose (FPG) from baseline after 16 weeks of treatment
Time frame: Baseline , 16 weeks
Safety Endpoints
Number of adverse events (AEs) and serious adverse events (SAEs), and number and percent
Time frame: Baseline , 17 weeks
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