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Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus

Type 2 Diabetes Clinical Trial

Official title:
A Phase 2, Multicenter, Randomised, Paralleled, Placebo-controlled (Double-blind) and Active Drug-controlled (Open) Study to Investigate Efficacy and Safety of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus

Clinical Trial Summary

This is a multicenter, randomized, parallel, placebo- and active comparator-controlled phase 2 trial to evaluate the efficacy, safety, pharmacokinetics and immunogenicity in subjects with T2DM. Patients treated with diet and exercise alone, or in combination with stable metformin monotherapy (≥1500 mg/day or maximum tolerated dose ≥1000 mg/ day.), will be enrolled. Approximately 225 participants will be randomized. The study includes four stages: screening period (up to 2 weeks), lead-in period (2 weeks), treatment period (12 weeks) and safety follow-up period (3 weeks after treatment).

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06148649
Study type Interventional
Source Dongguan HEC Biopharmaceutical R&D Co., Ltd.
Contact linong Ji, Doctor
Phone 13910978815
Email jiln@bjmu.edu.cn
Status Recruiting
Phase Phase 2
Start date December 10, 2023
Completion date September 30, 2024
View Details
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