This is a randomized, double-blind, placebo-controlled Phase Ib/IIa clinical study in Chinese patients with type 2 diabetes mellitus (T2DM) inadequately controlled with diet and exercise and/or treated with irregular use of antidiabetic drugs to evaluate the safety, tolerability, pharmacokinetics and efficacy of GZR18 injection in adult subjects with T2DM. This study is divided into Part A and Part B, which are to be conducted simultaneously.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
72
Gan & Lee Pharmaceuticals Co., Ltd
Beijing, China
Number of adverse events and serious adverse events
Time frame: 29 weeks
Changes from baseline in hemoglobin A1c (HbA1c) at the end of the study
Time frame: 26 weeks
Trough concentrations of GZR18 following consecutive doses
Time frame: 26 weeks
HbA1c control rate (proportions of subjects with HbA1c < 6.5 % and HbA1c < 7.0 %)
Time frame: 26 weeks
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