Multiple-dose Tolerability and Pharmacokinetic of IBI362 in Chinese Patients With T2DM

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).

• Eligibility Criteria： Inclusion Criiteria:

• Male or female 18 to 75 years of age at the time of consent.
• T2D patients with poorly controlled blood glucose treated with lifestyle intervention or stable dose of metformin (≥ 1000mg/day or maximum tolerated dose) within 2 months prior to screening.
• HbA1c 7.5% ≤ 11.0% by local laboratory at screening.
• Body mass index 20 ≤ BMI ≤ 35 kg/m2.

Exclusion criteria

• Type 1 diabetes, special types of diabetes, or gestational diabetes.
• Ketoacidosis or lactic acidosis within 6 months prior to screening.
• History of severe hypoglycaemic episodes within 6 months prior to screening.
• Acute myocardial infarction, unstable angina pectoris, coronary artery bypass grafting, coronary intervention (except diagnostic angiography), transient ischemic attack (TIA), cerebrovascular accident, acute and chronic heart failure within 6 months before screening.
• Clinically symptomatic liver disease, acute or chronic hepatitis, or transaminases (ALT and AST) and alkaline phosphatase (ALP) > 2 times the upper limit of normal and total bilirubin above the upper limit of normal at screening.
• The patient was previously diagnosed with autonomic neuropathy, manifested as urinary retention, resting tachycardia, orthostatic hypotension and diabetic diarrhea.