NCT05628311

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Clinical Study (DREAMS-1) to Evaluate the Efficacy and Safety of IBI362 in Chinese Type 2 Diabetes Patients With Poor Glycemia Control Only Through Diet and Exercise

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 319 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
OTHER	placebo	placebo administered subcutaneously (SC) once a week.
DRUG	IBI362	IBI362 administered subcutaneously (SC) once a week.

Timeline

• Start date: 2023-01-06
• Primary completion: 2023-10-25
• Completion: 2024-05-09
• First posted: 2022-11-28
• Last updated: 2024-08-20

Locations

1 site across 1 country: China