A Study of IBI362 in Poorly Controlled Type 2 Diabetes Patients Only Through Diet and Exercise
Status:
Not yet recruiting
Trial end date:
2025-01-15
Target enrollment:
Participant gender:
Summary
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.