This trial is conducted in China. The aim of the trial is to evaluate efficacy and Safety of IBI362 Versus dulaglutide as add-on to Metformin and/or SGLT2 inhibitor or TZD in Subjects With Type 2 Diabetes.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
731
Dulaglutide administered subcutaneously (SC) once a week.
IBI362 administered subcutaneously (SC) once a week.
China-Japan Friendship Hospital
Beijing, Beijin, China
HbA1c change from baseline at week 28
Time frame: Baseline, 28 weeks
percent change from baseline in body weigh
Time frame: Baseline, 28 weeks
Proportion of subjects with HbA1c <7.0% and weight loss ≥5% from baseline
Time frame: Baseline, 28 weeks
Change from baseline in HbA1c (superiority)
Time frame: Baseline, 28 weeks
Proportion of subjects with HbA1c <7.0%
Time frame: Baseline, 28 weeks
Safety,Incidence and severity of adverse events and correlation with study drug;
Time frame: Baseline to 32weeks
Time to peak plasma concentration (Tmax)
Time frame: Baseline to 28weeks
Time to peak plasma concentration (Cmax)
Time frame: Baseline to 28weeks
area under curve (AUC)
Time frame: Baseline to 28weeks
volume distribution (V)
Time frame: Baseline to 28weeks
half-life (half-life, T1/2
Time frame: Baseline to 28weeks
clearance rate (clearance, CL)
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Time frame: Baseline to 28weeks
To assess changes in PD parameters fasting insulin at different time points before and after administration.
Time frame: Baseline to 28weeks
To assess changes in PD parameters fasting C-peptide at different time points before and after administration.
Time frame: Baseline to 28weeks