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Efficacy and Safety Study of PEX168 in Combination Therapy Diabetes Mellitus Type 2 Patients With Metformin

NCT02477969 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 587

Last updated 2017-01-24

No results posted yet for this study

Summary

This is a multicenter, randomized, double-blind, placebo-controlled, phase III clinical study that will enroll approximately 564 T2DM patients who before screening have inadequately controlled blood glucose （7.0%≤HbA1c≤10.5% at randomization）despite at least 8 weeks of metformin monotherapy at stable doses（≥1500 mg/day).

Conditions

Interventions

DRUG

PEX168(100µg)

PEX168,100µg,Subcutaneous injection,once a week. continued for 52 weeks

DRUG

PEX168(200µg)

PEX168,Subcutaneous injection,once a week. continued for 52 weeks

DRUG

Placebo

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

DRUG

Metformin

0.5mg,oral,tid.

Sponsors & Collaborators

  • Jiangsu Hansoh Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Weiping Jia, MD · Shanghai the sixth 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
2014-02-27
Primary Completion
2016-06-22
Completion
2017-06-30

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 NCT02477969 on ClinicalTrials.gov