A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise

What this study is testing ClinicalTrials.gov NCT05628311 ↗

Description as written by the study sponsor.

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.

Treatments tested

• placebo Other

  placebo administered subcutaneously (SC) once a week.

• IBI362 Drug

  IBI362 administered subcutaneously (SC) once a week.