A Phase I Study of 8-week Continuous Treatment With Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Type 2 Diabetes

Intervention / Treatment
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* Drug: PEX168


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEX168 50 microgram<br>PEX168 50 microgram qw sc. and the medication continued for 8 weeks | Drug: PEX168<br>* A injection administered subcutaneously<br>* Other names: Polyethylene Glycol Loxenatide;|
| Experimental: PEX168 100 microgram<br>PEX168 100 microgram qw sc. and the medication continued for 8 weeks | Drug: PEX168<br>* A injection administered subcutaneously<br>* Other names: Polyethylene Glycol Loxenatide;|
| Experimental: PEX168 200 microgram<br>PEX168 200 microgram qw sc. and the medication continued for 8 weeks | Drug: PEX168<br>* A injection administered subcutaneously<br>* Other names: Polyethylene Glycol Loxenatide;|
| Experimental: PEX168 300 microgram<br>PEX168 300 microgram qw sc. and the medication continued for 8 weeks | Drug: PEX168<br>* A injection administered subcutaneously<br>* Other names: Polyethylene Glycol Loxenatide;|
| Placebo Comparator: Placebo<br>Placebo qw sc. and the medication continued for 12 weeks | Drug: PEX168<br>* A injection administered subcutaneously<br>* Other names: Polyethylene Glycol Loxenatide;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine serum concentrations of PEX168 |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determin HbA1c levels of PEX168 |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEX168, diabetes, phase I