Type 2 Diabetes
Conditions
Keywords
PEX168, diabetes, phase I
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.
Interventions
DRUGPEX168
A injection administered subcutaneously
Sponsors
Beijing Tongren Hospital
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. aged 20-65 years old, male or female, diagnosis of type 2 diabetes according to the 1999 WHO criteria more than 3 months. 2. 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). 3. unused insulin within 3 months prior to the enrollment. 4. Body mass index within the range from 19 to 35, and body weight does not changes exceeding 10% in the past 3 months. 5. Normol liver, kidney, heart function. 6. Willing to use physical means of contraception during the trial stage. 7. voluntarily to participate in the study.
Exclusion criteria
1. 1 diabetes. 2. used GLP-1, GLP-1 analogs or DPP-4 inhibitors in the past 3 months. 3. have diabetic ketoacidosis , diabetic hyperosmolar nonketotic coma patients with a history 4. There is a history of severe hypoglycemia : such as low blood sugar cause drowsiness , unconsciousness , nonsense , and even coma. 5. with severe diabetes complications ( renal , retinal , nerve , vascular disease). 6. has acute and chronic pancreatitis history ; 7. heart failure , unstable angina , severe arrhythmia, patients with a history of myocardial infarction ; 8. There is a history of hypertension and blood pressure is not well controlled : SBP\> 160mmHg and / or DBP\> 95mmHg persons ; 9. severe chronic gastrointestinal disease ( active ulcer nearly six months ) or have been affecting drug absorption in patients treated ; 10. There are obvious blood system diseases ; 11. There are other endocrine system diseases , such as hyperthyroidism , etc. ; 12. with severe trauma or surgery , severe infection ; 13. have mental illness , drug or other substance abuse or alcoholism ( drinking at least 2 times per week , more than 100g each drink ) ; 14. used any drugs that may affect the study , within 3 months before treatment as the subjects participated in any clinical trials ; 15. within the past six months more than 400ml of blood loss (including blood , trauma or other reasons ) ; 16. were receiving steroids or are receiving cancer treatment ; 17. has been prepared during pregnancy or pregnancy test in female patients ; 18. hepatitis B HBeAg , hepatitis C antibody positive , HIV antibody positive , syphilis antibody positive . 19. skin test positive of PEX168; 20. The researchers considered any factors that the subject should not participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine serum concentrations of PEX168 | 8 weeks |
Secondary
| Measure | Time frame |
|---|---|
| To determin HbA1c levels of PEX168 | 8 weeks |
Other
| Measure | Time frame |
|---|---|
| To assess number of participants with Adverse Events as a Measure of Safety and To assess number of participants with Adverse Events as a Measure of Safety and Tolerability | 8 weeks |
Countries
China
Outcome results
None listed