A Double-Blind, Multicenter, Randomized Study Evaluating the Safety, Tolerability and Pharmacokinetic/Pharmacodynamic Relationship in T2DMs Treated With 8 Weeks Injection of Polyethylene Glycol Loxenatide

Jiangsu HengRui Medicine Co., Ltd.1 site in 1 country50 target enrollmentStarted: June 2011Last updated: November 6, 2013

Conditions

Interventions

Drugs

Trial Snapshot

Phase: Phase 1
Status: Completed
Sponsor: Jiangsu HengRui Medicine Co., Ltd.
Enrollment: 50
Locations: 1
Primary Endpoint: To determine serum concentrations of PEX168

Study Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Study Overview

Brief 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 PK, PD and safety by 8-week continuous treatment of PEX168.

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Parallel
Primary Purpose: Treatment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages: 20 Years to 65 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•aged 20-65 years old, male or female, diagnosis of type 2 diabetes according to the 1999 WHO criteria more than 3 months.
•HbA1C 7.0-10.0% and fasting plasma glucose 7.0-10.0 mmol/L after treatment of diet, exercise or a single oral hypoglycemic agents (metformin , glimepiride or pioglitazone).
•unused insulin within 3 months prior to the enrollment.
•Body mass index within the range from 19 to 35, and body weight does not changes exceeding 10% in the past 3 months.
•Normol liver, kidney, heart function.
•Willing to use physical means of contraception during the trial stage.
•voluntarily to participate in the study.

Exclusion Criteria

•1 diabetes.
•used GLP-1, GLP-1 analogs or DPP-4 inhibitors in the past 3 months.
•have diabetic ketoacidosis , diabetic hyperosmolar nonketotic coma patients with a history
•There is a history of severe hypoglycemia : such as low blood sugar cause drowsiness , unconsciousness , nonsense , and even coma.
•with severe diabetes complications ( renal , retinal , nerve , vascular disease).
•has acute and chronic pancreatitis history ;
•heart failure , unstable angina , severe arrhythmia, patients with a history of myocardial infarction ;
•There is a history of hypertension and blood pressure is not well controlled : SBP> 160mmHg and / or DBP> 95mmHg persons ;
•severe chronic gastrointestinal disease ( active ulcer nearly six months ) or have been affecting drug absorption in patients treated ;
•There are obvious blood system diseases ;
•There are other endocrine system diseases , such as hyperthyroidism , etc. ;
•with severe trauma or surgery , severe infection ;
•have mental illness , drug or other substance abuse or alcoholism ( drinking at least 2 times per week , more than 100g each drink ) ;
•used any drugs that may affect the study , within 3 months before treatment as the subjects participated in any clinical trials ;
•within the past six months more than 400ml of blood loss (including blood , trauma or other reasons ) ;
•were receiving steroids or are receiving cancer treatment ;
•has been prepared during pregnancy or pregnancy test in female patients ;
•hepatitis B HBeAg , hepatitis C antibody positive , HIV antibody positive , syphilis antibody positive .
•skin test positive of PEX168;
•The researchers considered any factors that the subject should not participate in this trial.