Ignite Creation Date:
2025-12-24 @ 9:23 PM
Ignite Modification Date:
2026-01-01 @ 2:38 PM
Study NCT ID:
NCT04674332
Status:
COMPLETED
Last Update Posted:
2021-09-08
First Post:
2020-12-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long Acting Insulin Versus Multiple Dose Regimen for Control of Gestational Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D049528', 'term': 'Insulin, Long-Acting'}], 'ancestors': [{'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': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 148}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-04', 'studyFirstSubmitDate': '2020-12-14', 'studyFirstSubmitQcDate': '2020-12-14', 'lastUpdatePostDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-12-14', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'time needed to achieve glycemic control', 'timeFrame': '1 year', 'description': 'glycemic control assessed by fasting and postprandial blood sugar'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Long Acting Insulin in Control of Gestational Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'multiple dose regimen as a standard treatment for gestational diabetes will be compared to long acting insulin'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'they should be pregnant females', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* pregnant women with gestational diabetes mellitus\n* between 24-28 weeks gestation\n\nExclusion Criteria:\n\n* other endocrinological abnormalities'}, 'identificationModule': {'nctId': 'NCT04674332', 'briefTitle': 'Long Acting Insulin Versus Multiple Dose Regimen for Control of Gestational Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams University'}, 'officialTitle': 'Comparative Study Between Use of Long Acting Insulin Versus Multiple Dose Regimen in Control of Gestational Diabetes Mellitus', 'orgStudyIdInfo': {'id': '323/2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'long acting insulin', 'interventionNames': ['Drug: Long acting insulin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'multiple dose regimen', 'interventionNames': ['Drug: multiple dose regimen']}], 'interventions': [{'name': 'Long acting insulin', 'type': 'DRUG', 'description': 'long acting insulin analogue once daily at bed time', 'armGroupLabels': ['long acting insulin']}, {'name': 'multiple dose regimen', 'type': 'DRUG', 'description': 'intermediate and short acting insulin', 'armGroupLabels': ['multiple dose regimen']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Ain Shams University Maternity Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'associate professor', 'investigatorFullName': 'maii medhat nawara', 'investigatorAffiliation': 'Ain Shams University'}}}}