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

NCT05102149 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 672

Last updated 2022-02-08

No results posted yet for this study

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.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

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;

Sponsors & Collaborators

  • PegBio Co., Ltd.

    lead OTHER

Principal Investigators

  • Linong Ji, MD,PhD · Peking University People's Hospital

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
2021-09-30
Primary Completion
2023-11-30
Completion
2025-04-30

Countries

  • China
  • Hong Kong
  • Taiwan

Study Locations

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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 NCT05102149 on ClinicalTrials.gov