Phase 2Completed
Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus
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
- Sponsor
- Dongguan HEC Biopharmaceutical R&D Co., Ltd. (Industry)
- Enrolment
- 234 enrolled
- Conditions
- Type 2 Diabetes
- Interventions
- HEC88473, Placebo, Dulaglutide
- Ages
- adults, older adults
- Registry
- NCT06148649
Full record on ClinicalTrials.gov
From the registry
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).
Primary outcomes
- Change from baseline of HbA1c at week 12
History
Last registry update
Study completion
Primary completion
Started
Registered