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Dose-finding of PB-119 Administered Subcutaneously Once Weekly Versus Placebo in Subjects With Type 2 Diabetes

NCT03604419 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 214

Last updated 2020-01-22

No results posted yet for this study

Summary

A phase 2, multicenter study to evaluate the efficacy and safety of twelve once weekly subcutaneous doses of PB-119 to patients with type 2 diabetes mellitus (T2DM) not well-controlled by metformin mono therapy.

Conditions

  • Type 2 Diabetes Mellitus (T2DM)

Interventions

DRUG

PB-119 100 μg+ Glucophage®

Each patient will subsequently be randomized within the designated cohort to active drug or placebo

DRUG

PB-119 150 μg+ Glucophage®

Each patient will subsequently be randomized within the designated cohort to active drug or placebo

DRUG

PB-119 200 μg+ Glucophage®

Each patient will subsequently be randomized within the designated cohort to active drug or placebo

DRUG

PB-119 placebo + Glucophage®

Each patient will subsequently be randomized within the designated cohort to active drug or placebo

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • PegBio Co., Ltd.

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2018-06-13
Primary Completion
2019-07-23
Completion
2019-07-23
FDA Drug
Yes

Countries

  • United States

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 NCT03604419 on ClinicalTrials.gov