MedTrace Logo

Efficacy and Safety Study of PEX168 in Monotherapy Diabetes Mellitus Type 2 Patients

NCT02477865 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 406

Last updated 2017-01-24

No results posted yet for this study

Summary

This is a phase III, multicenter, randomized, double-blind, placebo-controlled study planning to include approximately 387 T2DM patients who have received at least 8 weeks of treatment with diet control and exercise； have not received any glucose-lowering agents within the 8 weeks prior to screening; and have inadequately controlled blood glucose.The subjects would receive PEX168 or placebo monotherapy for 52weeks in total.

Conditions

Interventions

DRUG

PEX168(100µg)

100µg,Subcutaneous injection,once a week. continued for 52 weeks

DRUG

PEX168(200µg)

200µg,Subcutaneous injection,once a week. continued for 52 weeks

DRUG

Placebo

0.5ml,Subcutaneous injection,once a week.continued for 24 weeks,then use PEX168 100µg or 200µg qw sc.for 28 weeks.

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wenying Yang, MD · China-Japan Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-03-23
Primary Completion
2016-05-15
Completion
2017-02-28

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 NCT02477865 on ClinicalTrials.gov