A PK/PD Study of Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes

NCT01965509 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2013-10-18

No results posted yet for this study

Summary

Polyethylene Glycol Loxenatide (PEX168) is a new human glucagon-like peptide 1 (GLP-1) analogue that created on the basis of the Exenatide and modified by polyethylene glycol (PEG).

This study aims to evaluate the effective therapeutic concentration range of PEX168, also decided to observe safety and PK/PD correlation by long-term continuous administration.

Conditions

Interventions

DRUG

PEX168 or placebo

injection has to administered subcutaneously weekly

Sponsors & Collaborators

  • China-Japan Friendship Hospital

    collaborator OTHER
  • Jiangsu HengRui Medicine Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wenying Yang, M.D · China-Japan Friendship Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2012-05-31
Primary Completion
2013-08-31
Completion
2013-10-31

Countries

  • China

Study Locations

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Entities

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 NCT01965509 on ClinicalTrials.gov