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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jiangsu HengRui Medicine Co., Ltd.
• Collaborator: Beijing Tongren Hospital

Criteria

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.