This trial is aimed to investigate the safety, tolerability, PK and PD of multiple subcutaneous injections of IBI362 in Chinese patients with type 2 diabetes who have poor glycemic control after lifestyle or metformin intervention
This is a multicenter, randomized, double-blind, placebo-controlled trial, the first trial to assess the safety, tolerability, and PK/PD of IBI362 administered as multiple injections in Chinese patients with type 2 diabetes. The investigators and subjects will be blinded to the study drug IBI362 and placebo. Dulaglutide will be used as an open-label active control group. In this trial, 42 eligible patients will be recruited and randomly allocated to three cohorts. Each corhot will be randomized as an 8:4:2 ratio to IBI362 (n = 8), placebo (n = 4), and Dulaglutide 1.5 mg (n = 2).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
42
Administrated by subcutaneous injection
Administrated by subcutaneous injection
Administrated by subcutaneous injection
China Japan Friendship Hospital
Beijing, China
To assess the number and incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] of IBI362 compared with placebo
Number of subjects with treatment emergent adverse events and serious adverse events through the end of the follow-up period
Time frame: From the first dose of study drug to week 19
The PK/PD parameters of IBI362 in patients with T2DM
Time frame: From Baseline to week 12
Evaluate the Peak Plasma Concentration (Cmax) of IBI362 in patients with T2DM
Time frame: From Baseline to week 12
Evaluate the Area under the plasma concentration versus time curve (AUC) of IBI362 in patients with T2DM
Time frame: From Baseline to week 12
Evaluate the Fasting Blood Glucose (FBG ) of IBI362 in patients with T2DM
Time frame: From Baseline to week 12
Evaluate the Glucagon of IBI362 in patients with T2DM
Time frame: From Baseline to week 12
Evaluate the Insulin of IBI362 in patients with T2DM
Time frame: From Baseline to week 12
Evaluate the C-peptide of IBI362 in patients with T2DM
Time frame: From Baseline to week 12
Number of Participants With Anti-IBI362 Antibodies
Serum samples will be analyzed by an electrochemiluminescence (ECL)-based immunoassay for anti-IBI362 binding antibodies. Positive samples will be subsequently tested in a receptor-ligand binding bioassay for anti-IBI362 neutralizing antibodies.
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Time frame: From the first dose of study drug to week 19