[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100561359":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":24,"responsibleParty":34,"collaborators":39,"id":41,"slug":42,"hasResults":43,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":24,"eligibilityCriteria":47,"healthyVolunteers":43,"sex":48,"minAge":49,"maxAge":50,"enrollmentInfo":51,"targetDuration":24,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":62,"whyStopped":24,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":24},{"fullName":5,"class":6},"Assiut University","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Metformin","EXPERIMENTAL","Metformin (500 to 2000 mg orally)",[13],"Drug: MetFORMIN 500 Mg Oral Tablet",{"label":15,"type":10,"description":16,"interventionNames":17},"Glyburide","Glyburide (2.5 mg to 20 mg orally)",[18],"Drug: GlyBURIDE 2.5 MG Oral Tablet",[20,25],{"type":21,"name":22,"description":11,"armGroupLabels":23,"otherNames":24},"DRUG","MetFORMIN 500 Mg Oral Tablet",[9],null,{"type":21,"name":26,"description":16,"armGroupLabels":27,"otherNames":24},"GlyBURIDE 2.5 MG Oral Tablet",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":24,"email":33},"Sherif Shazly, MSc","CONTACT","+447554480388","shazly.sherif2020@gmail.com",{"type":35,"investigatorFullName":36,"investigatorTitle":37,"investigatorAffiliation":38,"oldNameTitle":24,"oldOrganization":24},"PRINCIPAL_INVESTIGATOR","Sherif Abdelkarim Mohammed Shazly","Senior clinical fellow","Middle-Eastern College of Obstetricians and Gynecologists",[40],{"name":38,"class":6},"100561359","comparison-between-metformin-and-glyburide-in-the-management-of-gestational-diabetes-100561359",false,"NCT06589141","Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes","Comparison Between Metformin and Glyburide in the Management of Gestational Diabetes: a Randomized Controlled Trial (GDM-MERGE Trial)","Inclusion Criteria:\n\n* Pregnant women over 18 years old.\n* Gestational age between 24 - 28 weeks.\n* New diagnosis of gestational diabetes mellitus using a 2-hour glucose tolerance test.\n* Medical therapy is indicated to control blood glucose following the failure of diet and lifestyle changes to solely achieve glycemic control (A2GDM).\n\nExclusion Criteria:\n\nPatients with pre-gestational diabetes.\n\n* First trimester fasting blood glucose ≥105 mg\u002Fdl or HbA1c \\> 6.4%.\n* Major fetal anomalies.\n* Intrauterine growth restriction (IUGR) before 24 weeks.\n* Abnormal renal or liver function.\n* Contraindications to metformin or glyburide.\n* Medical treatment declined by the patient.\n* Direct indication to commence insulin (initial fasting blood glucose \\>= 7 mmol\u002Fl or 126 mg\u002Fdl or \\>= 6 mmol\u002Fl or 108 mg\u002Fdl with macrosomia or polyhydramnios).\n* Significant medical co-morbidities requiring continuous medical treatment in pregnancy.\n* Non-compliance to blood glucose self-monitoring (missing 50% or more of total readings)","FEMALE","18 Years","40 Years",{"count":52,"type":53},180,"ESTIMATED","INTERVENTIONAL",[56],"NA","This study aims to compare the maternal, fetal, and neonatal outcomes associated with the use of metformin versus glyburide for managing gestational diabetes.\n\nThe objective is to assess the safety and effectiveness profiles of both medications as potential alternatives to initiating insulin therapy.",[59],"Gestational Diabetes Mellitus in Pregnancy",[61],"Metformin and Glyburide","NOT_YET_RECRUITING","2024-09-05",{"date":65,"type":66},"2024-09-19","ACTUAL",{"date":68,"type":53},"2025-01-01",{"date":70,"type":53},"2026-06-30",{"name":5,"class":6}]