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Dose-finding of PB-119 Administered Subcutaneously Once-weekly Versus Placebo in Drug-naïve T2DM Subjects

NCT03520972 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 251

Last updated 2020-01-22

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, parallel dose cohort, multiple dose study to evaluate the efficacy, safety, and tolerability of different doses of PB-119 in drug-naïve subjects with T2DM.

Conditions

Interventions

DRUG

PB-119 75ug

60 eligible patients will be included in this group

DRUG

PB-119 150ug

60 eligible patients will be included in this group

DRUG

PB-119 200ug

60 eligible patients will be included in this group

DRUG

placebo

60 eligible patients will be included in this group

Sponsors & Collaborators

  • Tigermed Consulting Co., Ltd

    collaborator INDUSTRY

  • PegBio Co., Ltd.

    lead OTHER

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-06-05
Primary Completion
2019-07-29
Completion
2019-07-29

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT03520972 on ClinicalTrials.gov