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

NCT05326490 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 546

Last updated 2022-04-22

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • PegBio Co., Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-30
Primary Completion
2024-09-24
Completion
2024-10-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05326490 on ClinicalTrials.gov