[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100654607":3},{"organization":4,"outcomesModule":7,"designInfo":31,"detailedDescription":13,"studyPopulation":13,"armGroups":39,"interventions":52,"overallOfficials":62,"centralContacts":67,"locations":76,"responsibleParty":95,"collaborators":13,"id":98,"slug":99,"hasResults":100,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":13,"eligibilityCriteria":104,"healthyVolunteers":100,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":13,"studyType":111,"phases":112,"briefSummary":114,"conditions":115,"keywords":117,"overallStatus":78,"whyStopped":13,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":125,"completionDateStruct":127,"leadSponsor":129,"locationsCount":130},{"fullName":5,"class":6},"Nishtar Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":14},[9],{"measure":10,"description":11,"timeFrame":12},"Treatment Failure","Treatment failure will be defined as fewer than 80% of combined weekly blood glucose measurements being within the target range after treatment initiation. Target glucose levels are pre-prandial \\\u003C95 mg\u002FdL and post-prandial \\\u003C140 mg\u002FdL. Participants with treatment failure will be switched to insulin therapy.","From initiation of oral treatment, up to four weeks",null,[15,19,23,27],{"measure":16,"description":17,"timeFrame":18},"Polyhydramnios","Incidence of polyhydramnios based on an amniotic fluid index \\>24 ± 2 cm measured by obstetric ultrasonography.","From enrollment in the study up to delivery (till 42 weeks of gestation)",{"measure":20,"description":21,"timeFrame":22},"Preterm Delivery","Incidence of delivery occurring before 37 completed weeks of gestation.","From enrollment in the study up to delivery of the fetus (till 42 weeks of gestation)",{"measure":24,"description":25,"timeFrame":26},"Macrosomia","Incidence of newborn birth weight greater than 4,000 grams.","At delivery, with newborn birth weight assessed immediately after birth within three hours",{"measure":28,"description":29,"timeFrame":30},"NICU Admission","Number and proportion of newborn requiring admission to the neonatal intensive care unit according to institutional criteria","From birth through discharge from birth hospitalization, up to 48 hours",{"allocation":32,"interventionModel":33,"interventionModelDescription":13,"primaryPurpose":34,"observationalModel":13,"timePerspective":13,"maskingInfo":35},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":36,"maskingDescription":13,"whoMasked":37},"SINGLE",[38],"OUTCOMES_ASSESSOR",[40,46],{"label":41,"type":42,"description":43,"interventionNames":44},"Metformin","ACTIVE_COMPARATOR","Participants will receive metformin orally, once daily",[45],"Drug: Metformin",{"label":47,"type":48,"description":49,"interventionNames":50},"Glyburide","EXPERIMENTAL","Participants will receive glyburide orally, twice daily",[51],"Drug: Glyburide",[53,59],{"type":54,"name":41,"description":55,"armGroupLabels":56,"otherNames":57},"DRUG","Starting dose for Metformin will be 850 mg once daily after a meal and\u002For at 10:00 p.m. The dose will be increased to twice or three times daily according to weekly blood glucose measurements, up to a maximum of 2,550 mg\u002Fday. Treatment will continue until delivery.",[41],[58],"Glucophage",{"type":54,"name":47,"description":60,"armGroupLabels":61,"otherNames":13},"Starting dose of glyburide will be 2.5 mg twice daily, 30 minutes before meals and\u002For at 10:00 p.m. The dose will be increased according to weekly blood glucose measurements, up to a maximum of 20 mg\u002Fday. Treatment will continue until delivery.",[47],[63],{"name":64,"affiliation":65,"role":66},"Saima A Professor, FCPS","Nishtar Medical University and Hospital","STUDY_CHAIR",[68,73],{"name":69,"role":70,"phone":71,"phoneExt":13,"email":72},"Iqra M Principal Investigator, MBBS","CONTACT","+92 306 1324121","iqramahmoodjatoi321@gmail.com",{"name":64,"role":70,"phone":74,"phoneExt":13,"email":75},"+92 311 8443876","saimashahzad35177@gmail.com",[77],{"facility":65,"status":78,"city":79,"state":80,"zip":81,"country":82,"countryCode":83,"cosmosGeoPoint":84,"geoPoint":89,"contacts":90},"RECRUITING","Multan","Punjab Province","60000","Pakistan","PK",{"type":85,"coordinates":86},"Point",[87,88],71.47824,30.19679,{"lat":88,"lon":87},[91,92,93],{"name":69,"role":70,"phone":71,"phoneExt":13,"email":72},{"name":64,"role":70,"phone":74,"phoneExt":13,"email":75},{"name":69,"role":94,"phone":13,"phoneExt":13,"email":13},"PRINCIPAL_INVESTIGATOR",{"type":94,"investigatorFullName":96,"investigatorTitle":97,"investigatorAffiliation":5,"oldNameTitle":13,"oldOrganization":13},"Dr. Iqra Mahmood","Principal Investigator","100654607","phase-4-comparison-of-metformin-versus-glyburide-for-blood-sugar-control-in-women-with-gestational-diabetes-100654607",false,"NCT07802561","Comparison of Metformin Versus Glyburide for Blood Sugar Control in Women With Gestational Diabetes","Comparison of Metformin Versus Glyburide in the Control of Gestational Diabetes Mellitus","Inclusion Criteria:\n\n* Gestational diabetes requiring drug treatment\n* Gestational age between 13 - 33 weeks based on history and obstetric ultrasonography\n\nExclusion Criteria:\n\n* Known cases of diabetes mellitus\n* Serum creatinine \\> 1.2 mg \u002F dl\n* Chronic liver disease\n* Hypersensitivity to study medications","FEMALE","18 Years","45 Years",{"count":109,"type":110},92,"ESTIMATED","INTERVENTIONAL",[113],"PHASE4","The goal of this randomized clinical trial is to compare metformin and glyburide for controlling blood sugar in pregnant women with gestational diabetes mellitus (GDM) who require treatment with oral medication.\n\nThe main question the study aims to answer is:\n\nQ: Is treatment failure less common with metformin or glyburide in pregnant women with GDM?\n\nThe study will include 92 pregnant women aged 18-45 years with a singleton pregnancy, diagnosed with GDM between 13 and 33 weeks of pregnancy and requiring medication to control blood sugar. Participants will be randomly assigned to one of two treatment groups.\n\nParticipants in the metformin group will receive metformin, starting at 850 mg once daily and increased to a maximum of 2,550 mg per day according to their blood sugar levels.\n\nParticipants in the glyburide group will receive glyburide, starting at 2.5 mg twice daily and increased according to their blood sugar levels, up to a maximum of 20 mg per day.\n\nBlood glucose levels will be monitored regularly using a glucometer. Treatment will be considered successful when at least 80% of the recorded blood glucose measurements are within the target range. Treatment failure will be defined as fewer than 80% of blood glucose measurements being within the target range after up to 4 weeks of treatment. Participants who have treatment failure or cannot continue the assigned medication because of adverse effects will be switched to insulin therapy.\n\nParticipants will be followed during pregnancy until delivery. The study will record treatment failure as the primary outcome and will also assess maternal outcomes, including preeclampsia, polyhydramnios, and preterm delivery, as well as newborn outcomes including macrosomia and the need for admission to a neonatal intensive care unit (NICU).\n\nThe study will determine whether metformin or glyburide provides better blood sugar control and reduces the need to switch to insulin in pregnant women with gestational diabetes.",[116],"Gestational Diabetes Mellitus (GDM)",[118,47,119,120,41,10],"Gestational DIabetes Mellitus","Glycemic Control","Insulin Therapy","2026-08-30",{"date":123,"type":124},"2026-09-03","ACTUAL",{"date":126,"type":124},"2026-04-18",{"date":128,"type":110},"2026-10-17",{"name":5,"class":6},1]