Ignite Creation Date:
2025-12-24 @ 12:19 PM
Ignite Modification Date:
2026-01-27 @ 4:42 AM
Study NCT ID:
NCT01901861
Status:
COMPLETED
Last Update Posted:
2015-12-15
First Post:
2013-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of the DPP-4 Inhibitor Sitagliptin on Islet Function After Mixed Meal 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'}], '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': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-14', 'studyFirstSubmitDate': '2013-07-14', 'studyFirstSubmitQcDate': '2013-07-14', 'lastUpdatePostDateStruct': {'date': '2015-12-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Release of incretins hormones', 'timeFrame': '300 min'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['GLP-1, GIP, DPP-4 inhibition, iset function'], 'conditions': ['Type 2 Diabetes']}, 'descriptionModule': {'briefSummary': 'study hypothesis to examine the acute effects on glycaemia and islet hormone secretion of increased levels of endogenous GLP-1 and GIP on islet cell function in men with type 2 diabetes. To this purpose, a standardized mixed meal test will be ingested with or without concomitant administration of sitagliptin (100mg).', 'detailedDescription': 'In men subjects with type 2 diabetes treated with diet and exercise with or without metformin treatment as an antidiabetic agent, a standardized mixed meal test will be served with or without administration of sitagliptin (100mg).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Caucasian men with type 2 diabetes diagnosed according to ICD10\n* Ongoing treatment with life style adjustment or life style adjustment together with metformin as oral antidiabetic. Metformin therapy should not exceed 2 grams daily\n* Age 20-75 years\n* HbA1c ≤80 mmol/mol\n* BMI: 20-40 kg/m2\n\nExclusion Criteria:\n\n* Liver disease or ALAT three times above upper reference range\n* Diabetic nephropathy (GFR \\< 50 mL/min/1.73 m2 or albuminuria)\n* Proliferative diabetic retinopathy\n* Treatment with any glucose-lowering medication except metformin\n* Previous myocardial infarction, coronary heart disease or insatiable angina pectoris in the last 6 months.\n* Previous surgery on the gastrointestinal tract\n* Larger surgical intervention during the last 12 weeks\n* Treatment with oral steroids or thiazide diuretics\n* Treatment with digoxin\n* Smokers\n* Participation in another study the last 4 weeks\n* Paracetamol intolerance'}, 'identificationModule': {'nctId': 'NCT01901861', 'briefTitle': 'Effect of the DPP-4 Inhibitor Sitagliptin on Islet Function After Mixed Meal in Patients With Type 2 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Lund University'}, 'officialTitle': 'Effect of a Single Dose of the DPP-4 Inhibitor on Islet Function After Igestion of a Standardized Mixed Meal in Subjects With Type 2 Diabetes', 'orgStudyIdInfo': {'id': '2012-005660-98'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sitagliptin', 'description': 'Sitagliptin 100mg is given before meal ingestion', 'interventionNames': ['Drug: Sitagliptin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Placebo is given before meal ingestion', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Sitagliptin', 'type': 'DRUG', 'otherNames': ['Mixed meal test with sitagliptin'], 'description': 'Sitagliptin 100mg is given before meal ingestion', 'armGroupLabels': ['Sitagliptin']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Mixed meal test with placebo'], 'description': 'Placebo is given before meal ingestion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lund', 'country': 'Sweden', 'facility': 'Department of Clinical Science Lund,Lund University', 'geoPoint': {'lat': 55.70584, 'lon': 13.19321}}], 'overallOfficials': [{'name': 'Bo Ahren, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Lund University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lund University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'professor', 'investigatorFullName': 'Bo Ahren', 'investigatorAffiliation': 'Lund University'}}}}