Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-31 @ 1:46 PM
Study NCT ID:
NCT01976858
Status:
COMPLETED
Last Update Posted:
2013-11-06
First Post:
2013-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase I Study of 8-week Continuous Treatment With Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000601947', 'term': 'polyethylene glycol loxenatide'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-30', 'studyFirstSubmitDate': '2013-10-22', 'studyFirstSubmitQcDate': '2013-10-30', 'lastUpdatePostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': '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', 'timeFrame': '8 weeks'}], 'primaryOutcomes': [{'measure': 'To determine serum concentrations of PEX168', 'timeFrame': '8 weeks'}], 'secondaryOutcomes': [{'measure': 'To determin HbA1c levels of PEX168', 'timeFrame': '8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['PEX168, diabetes, phase I'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': '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).\n\nThis study aims to evaluate the PK, PD and safety by 8-week continuous treatment of PEX168.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. aged 20-65 years old, male or female, diagnosis of type 2 diabetes according to the 1999 WHO criteria more than 3 months.\n2. 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).\n3. unused insulin within 3 months prior to the enrollment.\n4. Body mass index within the range from 19 to 35, and body weight does not changes exceeding 10% in the past 3 months.\n5. Normol liver, kidney, heart function.\n6. Willing to use physical means of contraception during the trial stage.\n7. voluntarily to participate in the study.\n\nExclusion Criteria:\n\n1. 1 diabetes.\n2. used GLP-1, GLP-1 analogs or DPP-4 inhibitors in the past 3 months.\n3. have diabetic ketoacidosis , diabetic hyperosmolar nonketotic coma patients with a history\n4. There is a history of severe hypoglycemia : such as low blood sugar cause drowsiness , unconsciousness , nonsense , and even coma.\n5. with severe diabetes complications ( renal , retinal , nerve , vascular disease).\n6. has acute and chronic pancreatitis history ;\n7. heart failure , unstable angina , severe arrhythmia, patients with a history of myocardial infarction ;\n8. There is a history of hypertension and blood pressure is not well controlled : SBP\\> 160mmHg and / or DBP\\> 95mmHg persons ;\n9. severe chronic gastrointestinal disease ( active ulcer nearly six months ) or have been affecting drug absorption in patients treated ;\n10. There are obvious blood system diseases ;\n11. There are other endocrine system diseases , such as hyperthyroidism , etc. ;\n12. with severe trauma or surgery , severe infection ;\n13. have mental illness , drug or other substance abuse or alcoholism ( drinking at least 2 times per week , more than 100g each drink ) ;\n14. used any drugs that may affect the study , within 3 months before treatment as the subjects participated in any clinical trials ;\n15. within the past six months more than 400ml of blood loss (including blood , trauma or other reasons ) ;\n16. were receiving steroids or are receiving cancer treatment ;\n17. has been prepared during pregnancy or pregnancy test in female patients ;\n18. hepatitis B HBeAg , hepatitis C antibody positive , HIV antibody positive , syphilis antibody positive .\n19. skin test positive of PEX168;\n20. The researchers considered any factors that the subject should not participate in this trial.'}, 'identificationModule': {'nctId': 'NCT01976858', 'briefTitle': 'A Phase I Study of 8-week Continuous Treatment With Polyethylene Glycol Loxenatide in Patients With Type 2 Diabetes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'PEX168-I-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PEX168 50 microgram', 'description': 'PEX168 50 microgram qw sc. and the medication continued for 8 weeks', 'interventionNames': ['Drug: PEX168']}, {'type': 'EXPERIMENTAL', 'label': 'PEX168 100 microgram', 'description': 'PEX168 100 microgram qw sc. and the medication continued for 8 weeks', 'interventionNames': ['Drug: PEX168']}, {'type': 'EXPERIMENTAL', 'label': 'PEX168 200 microgram', 'description': 'PEX168 200 microgram qw sc. and the medication continued for 8 weeks', 'interventionNames': ['Drug: PEX168']}, {'type': 'EXPERIMENTAL', 'label': 'PEX168 300 microgram', 'description': 'PEX168 300 microgram qw sc. and the medication continued for 8 weeks', 'interventionNames': ['Drug: PEX168']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo qw sc. and the medication continued for 12 weeks', 'interventionNames': ['Drug: PEX168']}], 'interventions': [{'name': 'PEX168', 'type': 'DRUG', 'otherNames': ['Polyethylene Glycol Loxenatide'], 'description': 'A injection administered subcutaneously', 'armGroupLabels': ['PEX168 100 microgram', 'PEX168 200 microgram', 'PEX168 300 microgram', 'PEX168 50 microgram', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing tongren hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Jinkui Yang, Ph.D, M.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Beijing Tongren Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Beijing Tongren Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}