NCT05326490

Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients With Poor Glycemic Control Via Metformin Hydrochloride Monotherapy

A Multi-center, Randomized, Double-Blinded, Parallel and Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients With Poor Glycemic Control Via Metformin Hydrochloride Monotherapy

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 546 (estimated)
• Sponsor: PegBio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a Multi-center, Randomized, Double-Blinded, Parallel and Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of PB-201 in Type 2 Diabetic Mellitus Patients with Poor Glycemic Control via Metformin Hydrochloride Monotherapy

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
DRUG	PB-201	PB-201: 100 mg each time, orally in the morning and evening respectively
DRUG	PB-201 matched placebo	PB-201 matched placebo: One tablet each time, orally in the morning and evening respectively
DRUG	Metformin hydrochloride	The dosage and administration of metformin hydrochloride remain unchanged before screening

Timeline

• Start date: 2022-05-30
• Primary completion: 2024-09-24
• Completion: 2024-10-31
• First posted: 2022-04-13
• Last updated: 2022-04-22

Locations

1 site across 1 country: China