Phase 2 Study of HEC88473 Injection in Subjects With Type 2 Diabetes Mellitus
Status:
Recruiting
Trial end date:
2024-09-30
Target enrollment:
Participant gender:
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).