A Phase I Study of 8-week Continuous Treatment With Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes
NCT ID: NCT01976858
Last Updated: 2013-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
50 participants
INTERVENTIONAL
2011-06-30
2011-12-31
Brief Summary
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This study aims to evaluate the PK, PD and safety by 8-week continuous treatment of PEX168.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PEX168 50 microgram
PEX168 50 microgram qw sc. and the medication continued for 8 weeks
PEX168
A injection administered subcutaneously
PEX168 100 microgram
PEX168 100 microgram qw sc. and the medication continued for 8 weeks
PEX168
A injection administered subcutaneously
PEX168 200 microgram
PEX168 200 microgram qw sc. and the medication continued for 8 weeks
PEX168
A injection administered subcutaneously
PEX168 300 microgram
PEX168 300 microgram qw sc. and the medication continued for 8 weeks
PEX168
A injection administered subcutaneously
Placebo
Placebo qw sc. and the medication continued for 12 weeks
PEX168
A injection administered subcutaneously
Interventions
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PEX168
A injection administered subcutaneously
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
65 Years
ALL
No
Sponsors
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Beijing Tongren Hospital
OTHER
Jiangsu HengRui Medicine Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Jinkui Yang, Ph.D, M.D
Role: PRINCIPAL_INVESTIGATOR
Beijing Tongren Hospital
Locations
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Beijing tongren hospital
Beijing, Beijing Municipality, China
Countries
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Other Identifiers
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PEX168-I-03
Identifier Type: -
Identifier Source: org_study_id