[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586997":3},{"organization":4,"armGroups":7,"interventions":21,"overallOfficials":33,"centralContacts":44,"locations":51,"responsibleParty":122,"collaborators":27,"id":124,"slug":125,"hasResults":126,"nctId":127,"briefTitle":128,"officialTitle":128,"acronym":27,"eligibilityCriteria":129,"healthyVolunteers":126,"sex":130,"minAge":131,"maxAge":27,"enrollmentInfo":132,"targetDuration":27,"studyType":135,"phases":136,"briefSummary":138,"conditions":139,"keywords":141,"overallStatus":147,"whyStopped":27,"lastUpdateSubmitDate":148,"lastUpdatePostDateStruct":149,"startDateStruct":152,"completionDateStruct":154,"leadSponsor":156,"locationsCount":157},{"fullName":5,"class":6},"Dasman Diabetes Institute","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Pioglitazone and Dapagliflozin","ACTIVE_COMPARATOR","Group 1 will be started on dapagliflozin 10 mg per day plus 30 mg pioglitazone.",[13,14],"Drug: Dapagliflozin (DAPA)","Drug: Pioglitazone 45 mg",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo","PLACEBO_COMPARATOR","Group 2 will receive matching placebo",[20],"Drug: Placebo",[22,28,31],{"type":23,"name":24,"description":25,"armGroupLabels":26,"otherNames":27},"DRUG","Dapagliflozin (DAPA)","The hypothesis tested in the original study was whether the addition of pioglitazone in patients with type 1 diabetes mellitus (T1DM) receiving therapy with dapagliflozin would amplify the decrease in HbA1c and prevent the increase in plasma ketone concentration caused by dapagliflozin.",[9],null,{"type":23,"name":29,"description":25,"armGroupLabels":30,"otherNames":27},"Pioglitazone 45 mg",[9],{"type":23,"name":16,"description":16,"armGroupLabels":32,"otherNames":27},[16],[34,37,41],{"name":35,"affiliation":5,"role":36},"Fahd Al-Mulla, MD, PhD","STUDY_CHAIR",{"name":38,"affiliation":39,"role":40},"Muhammed Abdul Ghani, MD, PhD","Texas Diabetes Institute, Dasman Diabetes Institute","PRINCIPAL_INVESTIGATOR",{"name":42,"affiliation":5,"role":43},"Mohamed Abu-Farha, PhD","STUDY_DIRECTOR",[45],{"name":46,"role":47,"phone":48,"phoneExt":49,"email":50},"Mohamed Abu-farha, PhD","CONTACT","965-22242999","3010","Mohamed.abufarha@dasmaninstitute.org",[52,76,101],{"facility":5,"status":27,"city":53,"state":27,"zip":54,"country":55,"countryCode":56,"cosmosGeoPoint":57,"geoPoint":62,"contacts":63},"Kuwait City","1180","Kuwait","KW",{"type":58,"coordinates":59},"Point",[60,61],47.97429,29.367,{"lat":61,"lon":60},[64,68,71,73,75],{"name":65,"role":47,"phone":66,"phoneExt":27,"email":67},"Mohamed Abu-Farha","60660804","mohamed.abufarha@dasmaninstitute.org",{"name":69,"role":70,"phone":27,"phoneExt":27,"email":27},"Thamer Alessa, MD","SUB_INVESTIGATOR",{"name":72,"role":70,"phone":27,"phoneExt":27,"email":27},"Fahad Alajmi, MD",{"name":74,"role":70,"phone":27,"phoneExt":27,"email":27},"Abir Afyoni, MD",{"name":42,"role":70,"phone":27,"phoneExt":27,"email":27},{"facility":77,"status":27,"city":78,"state":27,"zip":27,"country":79,"countryCode":80,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"Hamad Medical Corporation","Doha","Qatar","QA",{"type":58,"coordinates":82},[83,84],51.53096,25.28545,{"lat":84,"lon":83},[87,91,93,95,97,99],{"name":88,"role":47,"phone":89,"phoneExt":27,"email":90},"Khaled Ahmed Baagar, MD","+974 6604 9423","KBaagar@hamad.qa",{"name":92,"role":40,"phone":27,"phoneExt":27,"email":27},"Khalid Ahmed Baagar, MD",{"name":94,"role":70,"phone":27,"phoneExt":27,"email":27},"AMIN AHMED JAYYOUSI, MD",{"name":96,"role":70,"phone":27,"phoneExt":27,"email":27},"Dabia HSH Al Mohanadi, MD",{"name":98,"role":70,"phone":27,"phoneExt":27,"email":27},"Hamda Ali AlMuhannadi, MD",{"name":100,"role":70,"phone":27,"phoneExt":27,"email":27},"Arwa E Alsaud, MD",{"facility":102,"status":27,"city":103,"state":27,"zip":27,"country":104,"countryCode":105,"cosmosGeoPoint":106,"geoPoint":110,"contacts":111},"Diabetes and Endocrine Treatment Center, Prince Sultan Military Medical City. Kidney & Pancreas Health Centre, Organ Transplant Centre of Excellence, King Faisal Specialist Hospital & Research Centre, Alfaisal Univeristy, Riyadh, Kingdom of Saudi Arabia","Riyadh","Saudi Arabia","SA",{"type":58,"coordinates":107},[108,109],46.72185,24.68773,{"lat":109,"lon":108},[112,116,120,121],{"name":113,"role":47,"phone":114,"phoneExt":27,"email":115},"Abdulmohsen Bakhsh, MD","+966557000696","abdulmohsen.bakhsh@gmail.com",{"name":117,"role":47,"phone":118,"phoneExt":27,"email":119},"Mohammed Saud Alenazi, MD","+966 54 329 9116","dr_mohammed.s@hotmail.com",{"name":113,"role":40,"phone":27,"phoneExt":27,"email":27},{"name":117,"role":40,"phone":27,"phoneExt":27,"email":27},{"type":123,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100586997","phase-4-can-the-addition-of-pioglitazone-to-sglt2-inhibitor-in-type-1-diabetic-patients-amplify-the-decrease-in-hba1c-and-prevent-the-increase-in-plasma-ketone-concentration-100586997",false,"NCT06922656","Can the Addition of Pioglitazone to SGLT2 Inhibitor in Type 1 Diabetic Patients Amplify the Decrease in HbA1c and Prevent the Increase in Plasma Ketone Concentration?","Inclusion Criteria:\n\n\\- 1) Age \\>18 years 2) T1DM 3) Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, Chem 20, CBC, TSH, urinalysis, and EKG.\n\n4\\) Fasting C-peptide concentration \\\u003C0.7 ng\u002Fml 5) Poor glycemic control (HbA1c=7.0-11.0%) 6) Treatment with multiple daily insulin injections (basal plus prandial) or insulin pump 7) Total daily insulin dose ≥0.6 U\u002Fkg per day 8) Stable insulin dose (±4 units) in the preceding three months. 9) eGFR≥60 ml\u002Fmin. 10) Weight stable over the preceding 3 months (± 3 pounds) and who do not participate in an excessively heavy exercise program\n\nExclusion Criteria:\n\n* 1\\) Age \\>18 years 2) T1DM 3) Other than diabetes, subjects must be in good general health as determined by physical exam, medical history, Chem 20, CBC, TSH, urinalysis, and EKG.\n\n  4\\) Fasting C-peptide concentration \\\u003C0.7 ng\u002Fml 5) Poor glycemic control (HbA1c=7.0-11.0%) 6) Treatment with multiple daily insulin injections (basal plus prandial) or insulin pump 7) Total daily insulin dose ≥0.6 U\u002Fkg per day 8) Stable insulin dose (±4 units) in the preceding three months. 9) eGFR≥60 ml\u002Fmin. 10) Weight stable over the preceding 3 months (± 3 pounds) and who do not participate in an excessively heavy exercise program","ALL","18 Years",{"count":133,"type":134},60,"ESTIMATED","INTERVENTIONAL",[137],"PHASE4","Previous data from our clinical trial has demonstrated that the combination of dapagliflozin plus pioglitazone cause robust decrease in the plasma glucose concentration without significant increase in plasma ketone concentration in subjects with T1DM receiving multiple insulin injections or insulin pump. Although patients receiving insulin therapy with pump have participated in the study, none has insulin delivered in automated pump (780 pump) which automatically adjusts the rate of insulin infusion based upon the measured plasma glucose concentration. Although automated insulin pumps have been introduced to practice only last year, they are gaining popularity in the care of T1DM patients worldwide. The aim of this amendment is to demonstrate the efficacy (decrease in HbA1c) and safety (no significant increase in plasma ketone concentration) of combination of dapagliflozin plus pioglitazone in T1DM patients receiving insulin therapy with automated insulin pump.",[140],"Type 1 Diabetes",[142,143,144,145,146],"Ketoacidosis","Hypoglycemia","Glucose Control","SGLT2 Inhibitors","Pioglitazone","NOT_YET_RECRUITING","2025-08-24",{"date":150,"type":151},"2025-08-29","ACTUAL",{"date":153,"type":134},"2025-09-15",{"date":155,"type":134},"2027-01-15",{"name":5,"class":6},3]