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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01976858
• Other study ID #: PEX168-I-03
• Status: Completed
• Phase: Phase 1
• First received: October 22, 2013
• Last updated: October 30, 2013
• Start date: June 2011
• Est. completion date: December 2011

Study information

• Verified date: October 2013
• Source: Jiangsu HengRui Medicine Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Drug:
• PEX168
A injection administered subcutaneously

Locations

Country	Name	City	State
China	Beijing tongren hospital	Beijing	Beijing

Sponsors (2)

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

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Primary	To determine serum concentrations of PEX168		8 weeks	No
Secondary	To determin HbA1c levels of PEX168		8 weeks	No