Ignite Creation Date:
2025-12-24 @ 10:09 PM
Ignite Modification Date:
2026-02-17 @ 6:13 PM
Study NCT ID:
NCT01678235
Status:
COMPLETED
Last Update Posted:
2014-10-07
First Post:
2012-08-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'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'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479079', 'term': 'insulin glulisine'}, {'id': 'D061267', 'term': 'Insulin Aspart'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-10-06', 'studyFirstSubmitDate': '2012-08-28', 'studyFirstSubmitQcDate': '2012-08-31', 'lastUpdatePostDateStruct': {'date': '2014-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Questionnaire: Glycemic Index Knowledge', 'timeFrame': 'each subject was asked to fullfill the questionnaire before entering the study (day one)'}], 'primaryOutcomes': [{'measure': 'Postprandial glycemia', 'timeFrame': 'baseline, 30, 60, 90, 120 and 180 minutes after the breakfast'}], 'secondaryOutcomes': [{'measure': 'Hypoglycemia episodes', 'timeFrame': '3-h study period', 'description': 'Hypoglycemia was defined as a PG concentration below 65 mg/dl with or without symptoms'}, {'measure': 'Glucose Area Under the Curve (AUC)', 'timeFrame': '3-h study period', 'description': 'based on continuous glucose monitoring system'}, {'measure': 'Mean amplitude of glycemic excursion (MAGE)', 'timeFrame': '3-h study period'}, {'measure': 'Difference between the maximum and baseline glycemia', 'timeFrame': '3-h study period'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['diabetes', 'insulin pump', 'glulisine', 'aspart', 'glycemic index'], 'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '24412929', 'type': 'RESULT', 'citation': 'Dzygalo K, Szypowska A. Impact of insulins glulisine and aspart on postprandial glycemia after a high-glycemic index meal in children with type 1 diabetes. Eur J Endocrinol. 2014 Mar 8;170(4):539-45. doi: 10.1530/EJE-13-0696. Print 2014 Apr.'}]}, 'descriptionModule': {'briefSummary': 'The aim of this study is to determine whether insulin glulisine is more effective in postprandial glycemic control than insulin aspart after the H-GI meal in children with type 1 diabetes (T1DM) treated with insulin pump (CSII).', 'detailedDescription': 'Some studies have suggested that insulin glulisine (GLU) has a slightly faster onset of action compared with insulin aspart (ASP). Meals of high glycemic index (H-GI) have distinct effect on postprandial glycaemia (PPG).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 1 diabetes mellitus\n* CSII for at least 3 months\n* Duration of diabetes \\> 1 years\n* Informed consent\n\nExclusion Criteria:\n\n* Concomitant dietary restrictions (e.g. celiac disease or food allergy)\n* Diabetes related complications\n* Baseline hyperglycemia \\>150 mg/dl\n* Any disease judged by the investigator to affect the trial'}, 'identificationModule': {'nctId': 'NCT01678235', 'briefTitle': 'Insulin Glulisine and Aspart in Postprandial Glycemic Control After High-GI Meal in Children With Type 1 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Medical University of Warsaw'}, 'officialTitle': 'The Impact Of Insulin Glulisine In Comparison With Aspart On Postprandial Glycemia After The High-Glycemic Index Meal In Children With Type 1 Diabetes - Cross-Over Double-Blind, Randomized Clinical Trial.', 'orgStudyIdInfo': {'id': 'Glulisine_Aspart'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GLU_ASP', 'description': "Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial.\n\nFirst day: insulin glulisine\n\nSecond day: insulin aspart", 'interventionNames': ['Drug: Insulin glulisine', 'Drug: Insulin aspart']}, {'type': 'EXPERIMENTAL', 'label': 'ASP_GLU', 'description': "Pre-breakfast insulin was given as a standard bolus 15 minutes before the high-glycemic index meal (cornflakes and milk). The carbo-insulin ratio on both study days was identical to the patient's ratio when entering trial.\n\nFirst day: insulin aspart\n\nSecond day: insulin glulisine", 'interventionNames': ['Drug: Insulin glulisine', 'Drug: Insulin aspart']}], 'interventions': [{'name': 'Insulin glulisine', 'type': 'DRUG', 'otherNames': ['Apidra®'], 'armGroupLabels': ['ASP_GLU', 'GLU_ASP']}, {'name': 'Insulin aspart', 'type': 'DRUG', 'otherNames': ['NovoRapid®'], 'armGroupLabels': ['ASP_GLU', 'GLU_ASP']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01-184', 'city': 'Warsaw', 'country': 'Poland', 'facility': 'Department of Pediatrics, Medical University of Warsaw, Poland', 'geoPoint': {'lat': 52.22977, 'lon': 21.01178}}], 'overallOfficials': [{'name': 'Katarzyna Dżygało, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Pediatrics, Medical University of Warsaw, Poland'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Medical University of Warsaw', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}