NCT04466904

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

A Multiple Dose Human Tolerability and Pharmacokinetic Study of IBI362 in Chinese Patients With Type 2 Diabetes Mellitus and Poor Glycemic Control

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Innovent Biologics (Suzhou) Co. Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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).

Conditions

• Type 2 Diabetes

Interventions

Type	Name	Description
DRUG	IBI362	Administrated by subcutaneous injection
DRUG	Placebo	Administrated by subcutaneous injection
DRUG	Dulaglutide	Administrated by subcutaneous injection

Timeline

• Start date: 2020-09-12
• Primary completion: 2021-05-28
• Completion: 2021-05-28
• First posted: 2020-07-10
• Last updated: 2021-07-23

Locations

1 site across 1 country: China