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

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.