This is a multicenter, randomized, double-blind, placebo-controlled phase III clinical study to evaluate the effectiveness and safety of IBI362 in patients with type 2 diabetes (T2D) with poor glycemia control only through diet and exercise. This study plans to enroll about 300 T2D subjects who still fail to meet the HbA1c standard after at least 2 months of simple diet and exercise control. During the whole study, subjects will be required to maintain diet and exercise control. The whole trial period includes a 2-week screening period, a 6-week introduction period, a 24 week double-blind treatment period, a 24 week study extension period and a 4-week safety follow-up period. Subjects who met the randomization criteria will be randomly assigned to the IBI362 4.0 mg group, the IBI362 6.0 mg group and the placebo group at 1:1:1. The randomization stratification factors were (V3) HbA1c\<8.5% or HbA1c ≥ 8.5% before randomization.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
319
placebo administered subcutaneously (SC) once a week.
IBI362 administered subcutaneously (SC) once a week.
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China
HbA1c change from baseline at week 24
Time frame: Baseline, 24 weeks
Proportion of subjects with HbA1c<7.0% at week 24
Time frame: Baseline, 24 weeks
Safety, Incidence and severity of adverse events and correlation with study drug;
Time frame: Baseline to 52 weeks
Time to peak plasma concentration (Tmax)
Time frame: Baseline to 52 weeks
Time to peak plasma concentration (Cmax)
Time frame: Baseline to 52 weeks
area under curve (AUC)
Time frame: Baseline to 52 weeks
volume distribution (V)
Time frame: Baseline to 52 weeks
half-life (half-life, T1/2)
Time frame: Baseline to 52 weeks
clearance rate (clearance, CL)
Time frame: Baseline to 52 weeks
To assess changes in PD parameters fasting insulin at different time points before and after administration.
Time frame: Baseline to 52 weeks
To assess changes in PD parameters fasting C-peptide at different time points before and after administration.
Time frame: Baseline to 52 weeks
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