NCT05102149

Study to Evaluate the Safety and Efficacy of PB-201 in Treatment-naive Patients With Type 2 Diabetes Mellitus

A Multi-center, Randomized, Double-Blinded, Parallel, Vildagliptin and Placebo-Controlled Phase III Clinical Study to Evaluate the Efficacy and Safety of PB-201 in Treatment-naive Patients With Type 2 Diabetes Mellitus

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 672 (estimated)
• Sponsor: PegBio Co., Ltd. · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, randomized, double-blind, parallel, Vildagliptin and Placebo-Controlled study to evaluate the efficacy and safety of oral administration of 100 mg of PB-201 in the morning and evening in treatmentnaive patients with type 2 diabetes mellitus.

Detailed description

The study consists of a screening period of up to 2 weeks, a 4-week single-blind run-in period, a 24-week double-blinded treatment period, a 28-week extended treatment period, and a 2-week safety follow-up period.Eligible subjects will be enrolled in a 4-week single-blind run-in period with daily oral administration of 1 tablet of PB-201 matched placebo and 1 Vildagliptin matched placebo in the morning and evening respectively.After the end of the single-blind run-in period, subjects who meet the protocol enrollment requirements will be randomized in the proportion of 2:1:1 to receive double-blinded treatment for 24 weeks in three different treatment groups (test arm, Vildagliptin arm, or placebo arm).

Conditions

• Type 2 Diabetes Mellitus (T2DM)

Interventions

Type	Name	Description
DRUG	PB-201	PB-201: 100 mg each time, orally in the morning and evening respectively;
DRUG	Vildagliptin	Vildagliptin: 50 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	Vildagliptin matched placebo	One tablet each time, orally in the morning and evening respectively;

Timeline

• Start date: 2021-09-30
• Primary completion: 2023-11-01
• Completion: 2025-04-01
• First posted: 2021-11-01
• Last updated: 2022-02-08

Locations

42 sites across 3 countries: China, Hong Kong, Taiwan