Ignite Creation Date:
2025-12-24 @ 6:48 PM
Ignite Modification Date:
2026-01-01 @ 10:03 AM
Study NCT ID:
NCT04726657
Status:
COMPLETED
Last Update Posted:
2021-01-27
First Post:
2021-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Two Biphasic Insulin Regimens
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}, {'id': 'C557564', 'term': 'insulin aspart, insulin aspart protamine drug combination 30:70'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Cross-over'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-01', 'completionDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-01-23', 'studyFirstSubmitDate': '2021-01-23', 'studyFirstSubmitQcDate': '2021-01-23', 'lastUpdatePostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-02-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in average blood glucose', 'timeFrame': '7 days', 'description': 'average blood glucose (mg/dl) from continuous glucose monitoring'}, {'measure': 'Glycated Albumin', 'timeFrame': '7 days', 'description': 'levels of glycated albumin (%) in serum'}, {'measure': 'Fructosamine', 'timeFrame': '7 days', 'description': 'levels of fructosamine (μmol/L) in serum'}], 'secondaryOutcomes': [{'measure': 'Daily Insulin requirements', 'timeFrame': '7 days', 'description': 'change in total daily dose of insulin (u)'}, {'measure': 'nocturnal average blood glucose', 'timeFrame': '7 days', 'description': 'change in nocturnal average blood glucose'}, {'measure': 'Time in range', 'timeFrame': '7 days', 'description': 'change in time in range (% and minutes) from continuous glucose monitoring'}, {'measure': 'time above 180', 'timeFrame': '7 days', 'description': 'change in time above 180 (% and minutes) from continuous glucose monitoring'}, {'measure': 'time below 70', 'timeFrame': '7 days', 'description': 'change in time below 70 (% and minutes) from continuous glucose monitoring'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes mellitus type 2', 'glycemic control', 'glycated albumin', 'continuous glucose monitoring', 'fructosamine', 'glycated hemoglobin', 'insulin', 'premixed human insulin', 'premixed insulin analog'], 'conditions': ['Diabetes Mellitus, Type 2']}, 'descriptionModule': {'briefSummary': 'Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices', 'detailedDescription': 'A cross-over study of 36 well controlled people with type 2 Diabetes Mellitus who underwent 7-day Continuous Glucose Monitoring with Premixed Human Insulin 30/70 and subsequently with Biphasic Aspart 30.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* regular attendees of Outpatient Clinic of the Diabetes Centre of the 1st Department of Internal Medicine of University Hospital in Thessaloniki Greece\n* The patients were on Premixed Human Insulin 30/70 twice daily with or without metformin\n* baseline HbA1c\\<7%\n\nExclusion Criteria:\n\n* the presence of type 1 Diabetes Mellitus\n* stage 4 Chronic Kidney Disease\n* use of antidiabetic medications other than insulin and metformin\n* major cardiovascular event during the last six months\n* acute illness and hospitalization during the last two weeks\n* pregnancy\n* absence of good metabolic control assessed with self-monitoring of blood glucose during the week before entering the study (\\>20% of the measurements \\<80mg/dl or \\>130mg/dl)\n* inability of the patients to understand the study procedures and sign the consent form'}, 'identificationModule': {'nctId': 'NCT04726657', 'briefTitle': 'Comparison of Two Biphasic Insulin Regimens', 'organization': {'class': 'OTHER', 'fullName': 'Aristotle University Of Thessaloniki'}, 'officialTitle': 'Comparison of Two Biphasic Insulin Regimens in Well-controlled Patients With the Use of Continuous Glucose Monitoring and New Glycemic Control Indices', 'orgStudyIdInfo': {'id': '2279'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Premixed Insulin', 'description': 'Premixed Human Insulin', 'interventionNames': ['Drug: Premixed Human Isophane Insulin Suspension + Human Insulin Injection', 'Drug: Premixed Insulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Premixed insulin', 'description': 'Premixed Insulin Analog', 'interventionNames': ['Drug: Premixed Human Isophane Insulin Suspension + Human Insulin Injection', 'Drug: Premixed Insulin']}], 'interventions': [{'name': 'Premixed Human Isophane Insulin Suspension + Human Insulin Injection', 'type': 'DRUG', 'otherNames': ['premixed human insulin'], 'description': 'premixed human insulin', 'armGroupLabels': ['Premixed Insulin', 'Premixed insulin']}, {'name': 'Premixed Insulin', 'type': 'DRUG', 'otherNames': ['Biphasic Aspart 30'], 'description': 'Premixed Insulin Analog Biphasic Aspart 30', 'armGroupLabels': ['Premixed Insulin', 'Premixed insulin']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Triantafyllos Didangelos, Assoc. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'AHEPA Hospital Aristotle University Of Thessaloniki'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Aristotle University Of Thessaloniki', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Hospital Tuebingen', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Internal Medicine-Diabetology', 'investigatorFullName': 'Prof. Triantafyllos Didangelos', 'investigatorAffiliation': 'Aristotle University Of Thessaloniki'}}}}