Ignite Creation Date:
2025-12-24 @ 12:09 PM
Ignite Modification Date:
2025-12-24 @ 12:09 PM
Study NCT ID:
NCT03659461
Status:
COMPLETED
Last Update Posted:
2022-03-15
First Post:
2018-08-29
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glucagon-like Peptide-1 Levels, Insulin Resistance and Insulin Sensitivity Index in Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'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': 'D000068900', 'term': 'Sitagliptin Phosphate'}], 'ancestors': [{'id': 'D014230', 'term': 'Triazoles'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011719', 'term': 'Pyrazines'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 174}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-13', 'studyFirstSubmitDate': '2018-08-29', 'studyFirstSubmitQcDate': '2018-09-02', 'lastUpdatePostDateStruct': {'date': '2022-03-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in blood glucose load response to sitagliptin', 'timeFrame': 'pre-treatment of sitagliptin and post 12-week treatment of sitagliptin', 'description': 'change from blood glucose response at 12 weeks'}, {'measure': 'change in blood insulin response to sitagliptin', 'timeFrame': 'pre-treatment of sitagliptin and post 12-week treatment of sitagliptin', 'description': 'change from blood insulin response at 12 weeks'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 2 Diabetes Mellitus', 'PreDiabetes']}, 'descriptionModule': {'briefSummary': 'This study is conducted to examine GLP-1, insulin resistance and insulin sensitivity portfolio in Malay, Chinese and Indian populations in Malaysia and to study the effect of DPPIV inhibitor in T2DM patients with different GLP-levels.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subjects are newly diagnosed of T2DM according to World Health Organisation criteria) and do not receive any glucose-lowering drugs\n* Subjects with normal glucose tolerance test according to World Health Organisation criteria which is carried out immediately before inclusion in the study\n* Subjects who are willing to participate and sign the informed consent form\n\nExclusion Criteria:\n\n* Patients with pre-existing T2DM\n* Patients with family history of diabetes\n* Patients receiving glucose-lowering medications\n* Patients with anemia, abnormal serum creatinine level, macroalbuminuria, proliferative retinopathy, impaired liver function'}, 'identificationModule': {'nctId': 'NCT03659461', 'acronym': 'GLP-1', 'briefTitle': 'Glucagon-like Peptide-1 Levels, Insulin Resistance and Insulin Sensitivity Index in Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'National University of Malaysia'}, 'officialTitle': 'Comparative Study of Incretin System in Three Ethnic Groups With Abnormal Glucose Tolerance', 'orgStudyIdInfo': {'id': 'UKM-22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low GLP-1 arm', 'description': 'Subjects are required to take oral 100mg Sitagliptin (Januvia) daily before breakfast for 12 weeks. 100mg is the recommended treatment dose. During the treatment with Januvia, subjects are not allowed to take any other medications except metformin', 'interventionNames': ['Drug: Sitagliptin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'normal GLP-1 arm', 'description': 'Subjects are required to take oral 100mg Sitagliptin ( Januvia) daily before breakfast for 12 weeks. 100mg is the recommended treatment dose. During the treatment with Januvia, subjects are not allowed to take any other medications except metformin', 'interventionNames': ['Drug: Sitagliptin']}], 'interventions': [{'name': 'Sitagliptin', 'type': 'DRUG', 'description': 'oral 100mg Sitagliptin daily will be given for 12 weeks. Subjects are required to undergo OGTT pre and post treatment.', 'armGroupLabels': ['low GLP-1 arm', 'normal GLP-1 arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '81100', 'city': 'Johor Bahru', 'state': 'Johor', 'country': 'Malaysia', 'facility': 'Hospital Sultan Ismail', 'geoPoint': {'lat': 1.4655, 'lon': 103.7578}}], 'overallOfficials': [{'name': 'Kamaruddin Nor Azmi', 'role': 'STUDY_DIRECTOR', 'affiliation': 'National University of Malaysia'}, {'name': 'Shiau Chin Chong', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National University of Malaysia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National University of Malaysia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Pharmacist', 'investigatorFullName': 'Chong Shiau Chin', 'investigatorAffiliation': 'National University of Malaysia'}}}}