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infection","drugRate":"0.0%","organSystem":"Infections and infestations","placeboRate":"","totalAtRisk":34,"totalAffected":0,"trialsReporting":1}],"contraindications":["severe kidney disease (or if you are on dialysis)","heart problems","a diabetic foot ulcer or amputation","circulation problems or nerve problems in your legs or feet","liver or kidney disease","bladder infections or other urination problems","low blood pressure","diabetic ketoacidosis","problems with your pancreas, including surgery","if you drink alcohol often","if you have a planned surgery","if you have type 1 diabetes","if you are on a low salt diet","pregnancy (second or third trimester)","breastfeeding"],"specialPopulations":{"Pregnancy":"Based on animal data showing adverse renal effects, STEGLATRO is not recommended during the second and third trimesters of pregnancy. The limited available data with STEGLATRO in pregnant women are not sufficient to determine a drug-associated risk of adverse developmental outcomes. There are risks to the mother and fetus associated with poorly controlled diabetes in pregnancy (see Clinical Considerations).  In animal studies, adverse renal changes were observed in rats when ertugliflozin was administered during a period of renal development corresponding to the late second and third trimesters of human   ...    dilatations and renal mineralization that were not fully reversible. There was no evidence of fetal harm in  increases   ...    corresponding to human kidney maturation were associated with a risk to the developing kidney (persistent increased organ weight, renal mineralization, and renal pelvic and tubular dilatations).","Geriatric use":"No dosage adjustment of STEGLATRO is recommended based on age. In STEGLATRO clinical trials, a total of 876 (25.7%) patients treated with STEGLATRO were 65 years and older, and 152 (4.5%) patients treated with STEGLATRO were 75 years and older. Patients 65 years and older had a higher","Paediatric use":"Safety and effectiveness of STEGLATRO in pediatric patients under 18 years of age have not been established.","Renal impairment":"Higher incidence of adverse reactions related to reduced intravascular volume and renal function.","Hepatic impairment":"No dosage adjustment of STEGLATRO is necessary in patients with mild or moderate hepatic impairment. Ertugliflozin has not been studied in patients with severe hepatic impairment and is not recommended for use in this patient population [see Clinical Pharmacology (12.3)]."},"seriousAdverseEvents":[{"event":"Post procedural infection","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"1.6%"},{"event":"Foot fracture","detail":"Injury, poisoning and procedural complications. 1 trial(s).","severity":"serious","incidence":"1.6%"},{"event":"Tibia fracture","detail":"Injury, poisoning and procedural complications. 1 trial(s).","severity":"serious","incidence":"1.6%"},{"event":"Hyperglycaemia","detail":"Metabolism and nutrition disorders. 1 trial(s).","severity":"serious","incidence":"1.6%"},{"event":"COVID-19 pneumonia","detail":"Infections and infestations. 1 trial(s).","severity":"serious","incidence":"0.0%"},{"event":"Hypoglycaemia","detail":"Metabolism and nutrition disorders. 1 trial(s).","severity":"serious","incidence":"0.0%"}]},"trials":[],"aliases":[],"company":"Pfizer","patents":[],"pricing":[],"_sources":{"trials":{"url":"https://clinicaltrials.gov/search?intr=ertugliflozin-15-mg","method":"api_direct","source":"ClinicalTrials.gov","rawText":"","confidence":1,"sourceType":"ctgov","retrievedAt":"2026-04-19T23:37:23.186750+00:00"},"patents":{"url":"","method":"deterministic","source":"FDA Orange Book + Purple Book","rawText":"","confidence":1,"sourceType":"fda_orange_book","retrievedAt":"2026-04-20T07:30:06.256919+00:00"},"chemblData":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5315054/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-20T07:30:00.041261+00:00"},"trialDetails":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (2 trials with endpoints)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:30:08.599403+00:00"},"regulatory.ca":{"url":"","method":"api_direct","source":"Health Canada DPD","rawText":"","confidence":1,"sourceType":"health_canada_dpd","retrievedAt":"2026-04-19T23:37:28.780679+00:00"},"regulatory.eu":{"url":"","method":"api_direct","source":"European Medicines Agency","rawText":"","confidence":1,"sourceType":"ema_api","retrievedAt":"2026-04-19T23:37:23.260281+00:00"},"targetProtein":{"url":"https://www.uniprot.org/uniprot/P31639","method":"api_direct","source":"UniProt (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"uniprot","retrievedAt":"2026-04-20T07:29:54.003589+00:00"},"publicationCount":{"url":"","method":"api_direct","source":"PubMed/NCBI","rawText":"","confidence":1,"sourceType":"pubmed","retrievedAt":"2026-04-20T07:29:58.866247+00:00"},"participantFlowData":{"url":"","method":"deterministic","source":"ClinicalTrials.gov participantFlowModule","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:30:08.599385+00:00"},"structuredTrialResults":{"url":"","method":"deterministic","source":"ClinicalTrials.gov resultsSection (2 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:30:08.599377+00:00"},"mechanism.target_chembl":{"url":"","method":"api_direct","source":"ChEMBL mechanism: Sodium/glucose cotransporter 2 inhibitor","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:37:31.091849+00:00"},"crossReferences.chemblId":{"url":"https://www.ebi.ac.uk/chembl/compound_report_card/CHEMBL5315054/","method":"api_direct","source":"ChEMBL (EMBL-EBI)","rawText":"","confidence":1,"sourceType":"chembl","retrievedAt":"2026-04-19T23:37:30.740361+00:00"},"safety.commonSideEffects":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (2 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T08:28:35.400014+00:00"},"safety.seriousAdverseEvents":{"url":"","method":"deterministic","source":"ClinicalTrials.gov (2 trials)","rawText":"","confidence":1,"sourceType":"ctgov_results","retrievedAt":"2026-04-20T07:30:08.599168+00:00"}},"allNames":"ertugliflozin 15 mg","offLabel":[],"timeline":[],"aiSummary":"Ertugliflozin 15 mg, developed by Pfizer Inc., is a medication used to treat type 2 diabetes mellitus and reduce cardiovascular events. It works by inhibiting the SGLT2 protein, which is involved in glucose reabsorption in the kidneys. This leads to increased glucose excretion in the urine, resulting in improved glycemic control. Ertugliflozin has been shown to reduce the risk of major adverse cardiovascular events in adults with type 2 diabetes and established cardiovascular disease. The medication has been commercially successful, generating $7,366 million in revenue. With 14 clinical trials and 30 publications, the efficacy and safety of ertugliflozin have been extensively studied. Its mechanism of action and clinical benefits make it a valuable treatment option for patients with type 2 diabetes.","brandName":"Ertugliflozin 15 mg","ecosystem":[],"isGeneric":true,"mechanism":{"target":"SGLT2","novelty":"best-in-class","modality":"small molecule","drugClass":"SGLT2 inhibitor","explanation":"","oneSentence":"","technicalDetail":"Ertugliflozin selectively inhibits the SGLT2 protein, which is responsible for approximately 90% of glucose reabsorption in the kidneys. This results in a dose-dependent increase in urinary glucose excretion and a decrease in blood glucose levels. The medication has a rapid onset of action, with peak effects observed within 1-2 hours after administration."},"_companyIR":{"url":"https://www.pfizer.com/investors","revenueRefs":[],"pipelineRefs":[]},"chemblData":{"prodrug":0,"chemblId":"CHEMBL5315054","maxPhase":"4.0","chirality":1,"parenteral":false,"availability":1,"moleculeType":"Small molecule","withdrawnFlag":false,"naturalProduct":0,"blackBoxWarning":0,"oralBioavailable":true},"commercial":{"annualCostUS":"$80,000/yr","genericStatus":"Generic — off-patent","currentRevenue":"$7,366 million","peakSalesEstimate":"Not publicly reported"},"fdaRecalls":[],"references":[{"id":1,"url":"https://clinicaltrials.gov/search?intr=ertugliflozin-15-mg","fields":["trials"],"source":"ClinicalTrials.gov"},{"id":2,"url":"https://pubmed.ncbi.nlm.nih.gov/?term=ertugliflozin-15-mg","fields":["publications"],"source":"PubMed/NCBI"},{"id":3,"url":"https://www.ebi.ac.uk/chembl/","fields":["molecular"],"source":"ChEMBL (EMBL-EBI)"},{"id":4,"url":"https://www.ema.europa.eu/","fields":["regulatoryStatus"],"source":"European Medicines Agency (EMA)"},{"id":5,"url":"https://list.essentialmeds.org/","fields":["regulatoryStatus"],"source":"WHO Essential Medicines List"}],"_tgaChecked":true,"_validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-20T08:28:36.585175+00:00","fieldsConflicting":0,"overallConfidence":0.95},"_whoChecked":true,"biosimilars":[],"competitors":[{"name":"Metformin","company":"Not specified","advantage":"Improves how the body responds to insulin"},{"name":"Ozempic","company":"Not specified","advantage":"Not specified"},{"name":"Jardiance","company":"Not specified","advantage":"Not specified"},{"name":"Glimepiride","company":"Not specified","advantage":"Not specified"},{"name":"Glipizide","company":"Not specified","advantage":"Not specified"},{"name":"Victoza","company":"Not specified","advantage":"Not specified"},{"name":"Januvia","company":"Not specified","advantage":"Not specified"},{"name":"Kirsty (insulin aspart)","company":"Not specified","advantage":"Not specified"}],"genericName":"ertugliflozin-15-mg","indications":{"approved":[{"name":"Treatment of type 2 diabetes mellitus as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes","regulator":"FDA"}],"offLabel":[],"pipeline":[]},"_mhraChecked":true,"labelChanges":[],"relatedDrugs":[],"trialDetails":[{"nctId":"NCT04029480","phase":"PHASE3","title":"Ertugliflozin Type 2 Diabetes Mellitus (T2DM) Pediatric Study (MK-8835/PF-04971729) (MK-8835-059)","status":"","acronym":null,"sponsor":"Merck Sharp & Dohme LLC","isPivotal":false,"primaryCI":"[-1.06, -0.29]","primaryHR":"-0.67","enrollment":166,"indication":"Type 2 Diabetes Mellitus","endpointCount":10,"primaryPValue":"","completionDate":"","primaryEndpoint":"Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo)"},{"nctId":"NCT05727579","phase":"PHASE4","title":"DiEtary Sodium Intake Effects on Ertugliflozin-induced Changes in GFR, reNal Oxygenation and Systemic Hemodynamics: the DESIGN Study","status":"","acronym":"DESIGN","sponsor":"Amsterdam UMC, location VUmc","isPivotal":false,"primaryCI":"","primaryHR":"-4.2","enrollment":41,"indication":"Diabetes Mellitus, Diabetic Kidney Disease","endpointCount":1,"primaryPValue":"0.0174","completionDate":"","primaryEndpoint":"To Investigate the Modifying Effect of Sodium Intake on Ertugliflozin on Blood Pressure"}],"_emaApprovals":[{"date":"","name":"Ertugliflozin 15 mg","status":"Authorised","regulator":"EMA"}],"genericFilers":[],"latestUpdates":[],"manufacturing":[],"molecularData":{"oral":true,"chemblId":"CHEMBL5315054","moleculeType":"Small molecule","molecularWeight":"566.00"},"targetProtein":{"url":"https://www.uniprot.org/uniprot/P31639","function":"Electrogenic Na(+)-coupled sugar symporter that actively transports D-glucose at the plasma membrane, with a Na(+) to sugar coupling ratio of 1:1 (PubMed:20980548, PubMed:28592437, PubMed:34880493, PubMed:37217492, PubMed:38057552). Transporter activity is driven by a transmembrane Na(+) electrochemical gradient set by the Na(+)/K(+) pump (PubMed:20980548, PubMed:28592437, PubMed:34880493). Unlike SLC5A1/SGLT1, requires the auxiliary protein PDZK1IP1/MAP17 for full transporter activity (PubMed:3","geneName":"SLC5A2","organism":"Homo sapiens","uniprotId":"P31639","proteinName":"Sodium/glucose cotransporter 2","sequenceLength":672,"molecularWeight":72897,"subcellularLocation":"Apical cell membrane"},"_patentsChecked":true,"_warningLetters":[{"date":"03/28/2023","subject":"11/07/2022\tTodos Medical Ltd aka Todos Medical USA Inc\tCenter for Food Safety and Applied Nutrition"},{"date":"03/27/2026","subject":"Feedback form"}],"crossReferences":{"chemblId":"CHEMBL5315054"},"formularyStatus":[],"_offLabelChecked":true,"chemblMechanisms":[{"actionType":"INHIBITOR","targetChemblId":"CHEMBL3884","mechanismComment":null,"mechanismOfAction":"Sodium/glucose cotransporter 2 inhibitor"}],"developmentCodes":[],"ownershipHistory":[],"publicationCount":30,"therapeuticAreas":["Metabolic"],"biosimilarFilings":[],"recentPublications":[{"date":"2025 Jun","pmid":"40662231","title":"Liquid chromatography-tandem mass spectrometry method for quantification of ertugliflozin in human plasma: Application to disposition kinetics.","journal":"European journal of mass spectrometry (Chichester, England)"},{"date":"2025 Jan-Dec","pmid":"40028005","title":"Cardiovascular and Renal Outcomes with Ertugliflozin by Baseline Use of Renin-Angiotensin-Aldosterone System Inhibitors or Diuretics, Including Mineralocorticoid Receptor Antagonist: Analyses from the VERTIS CV Trial.","journal":"Kidney diseases (Basel, Switzerland)"},{"date":"2024","pmid":"39354951","title":"Efficacy and Safety of Ertugliflozin Compared to Placebo in Patients With Type 2 Diabetes: An Updated Systematic Review and Meta-Analysis.","journal":"Journal of diabetes research"},{"date":"2024 Nov","pmid":"39219437","title":"Effects of ertugliflozin on uric acid and gout-related outcomes in persons with type 2 diabetes and cardiovascular disease: Post hoc analyses from VERTIS CV.","journal":"Diabetes, obesity & metabolism"},{"date":"2023 Apr","pmid":"37003273","title":"Cardiorenal outcomes, kidney function, and other safety outcomes with ertugliflozin in older adults with type 2 diabetes (VERTIS CV): secondary analyses from a randomised, double-blind trial.","journal":"The lancet. Healthy longevity"}],"_drugWebsiteChecked":true,"participantFlowData":[{"nctId":"NCT04029480","groups":[{"id":"FG000","title":"5 mg Ertugliflozin","description":"Participants received 5 mg ertugliflozin (ERTU) once daily (QD) and placebo to 15 mg ERTU QD until Week 54 (WK54). At Week 12 (WK12), participants who did not meet the up-titration criteria remained o"},{"id":"FG001","title":"5 mg/5 mg Ertugliflozin","description":"Participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participa"},{"id":"FG002","title":"5 mg/15 mg Ertugliflozin","description":"Participants initially received 5 mg ERTU QD and placebo to 15 mg ERTU QD until WK12. Participants remained on their background metformin with/without insulin treatment throughout the study. Participa"},{"id":"FG003","title":"Placebo","description":"Participants received matched placebo to 5 mg ERTU and 15 mg ERTU from baseline to WK54. Participants remained on their background metformin with/without insulin treatment throughout the study."}],"acronym":null,"periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"63","FG001":"22","FG002":"26","FG003":"55"}},{"type":"Re-Randomized","counts":{"FG000":"0","FG001":"22","FG002":"26","FG003":"0"}},{"type":"COMPLETED","counts":{"FG000":"61","FG001":"22","FG002":"23","FG003":"53"}},{"type":"NOT COMPLETED","counts":{"FG000":"2","FG001":"0","FG002":"3","FG003":"2"}}],"dropWithdraws":[{"type":"Physician Decision","counts":{"FG000":"0","FG001":"0","FG002":"2","FG003":"1"}},{"type":"Withdrawal by Subject","counts":{"FG000":"2","FG001":"0","FG002":"1","FG003":"1"}}]}],"recruitment":"","preAssignment":"Participants were screened up to 4 weeks before dosing. Participants were confirmed at screening to have T2DM for ≥2 years, conform to T2DM protocol specific requirements and be on stable metformin with or without insulin.\n\nThe first randomization was stratified according to the following factors collected at screening: age (10 to 14 years of age/15 to 17 years) and insulin use (yes/no).\n\nTreatment randomization at Week 12 was stratified according to insulin use (yes/no) at screening."},{"nctId":"NCT05727579","groups":[{"id":"FG000","title":"A - B - C - D","description":"A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day"},{"id":"FG001","title":"A - C - D - B","description":"A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day"},{"id":"FG002","title":"B - A - D - C","description":"A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day"},{"id":"FG003","title":"B - D - C - A","description":"A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day"},{"id":"FG004","title":"C - A - B - D","description":"A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day"},{"id":"FG005","title":"C - B - D - A","description":"A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day"},{"id":"FG006","title":"D - A - B - C","description":"A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day"},{"id":"FG007","title":"D - A - C - B","description":"A = moderate sodium diet (90 mmol/day for 20 days) + placebo for 10 days B = moderate sodium diet (90 mmol/day for 20 days) + ertugliflozin 15mg per day for 10 days C = high sodium diet ( 250 mmol/day"}],"acronym":"DESIGN","periods":[{"title":"Overall Study","milestones":[{"type":"STARTED","counts":{"FG000":"6","FG001":"4","FG002":"6","FG003":"5","FG004":"6","FG005":"5","FG006":"4","FG007":"5"}},{"type":"COMPLETED","counts":{"FG000":"5","FG001":"3","FG002":"5","FG003":"4","FG004":"6","FG005":"4","FG006":"3","FG007":"4"}},{"type":"NOT COMPLETED","counts":{"FG000":"1","FG001":"1","FG002":"1","FG003":"1","FG004":"0","FG005":"1","FG006":"1","FG007":"1"}}],"dropWithdraws":[{"type":"Withdrawal by Subject","counts":{"FG000":"1","FG001":"1","FG002":"1","FG003":"1","FG004":"0","FG005":"1","FG006":"1","FG007":"1"}}]}],"recruitment":"","preAssignment":"Of 61 individuals screened, 41 were enrolled. The required sample size was 34 participants; additional participants were enrolled to account for anticipated dropouts."}],"_healthCanadaChecked":true,"companionDiagnostics":[],"_genericFilersChecked":true,"structuredTrialResults":[{"hr":"-0.67","nctId":"NCT04029480","phase":"PHASE3","pValue":"","ciLower":"-1.06","ciUpper":"-0.29","endpoint":"Change From Baseline in Hemoglobin A1C (HbA1C) at Week 24 (Combined Ertugliflozin Versus Placebo)","enrollment":166},{"hr":"-4.2","nctId":"NCT05727579","phase":"PHASE4","pValue":"0.0174","ciLower":"","ciUpper":"","endpoint":"To Investigate the Modifying Effect of Sodium Intake on Ertugliflozin on Blood Pressure","enrollment":41}],"genericManufacturerList":[],"phase":"marketed","status":"approved","companyName":"Pfizer","companyId":"pfizer","modality":"Small molecule","firstApprovalDate":"","enrichmentLevel":5,"visitCount":8,"regulatoryByCountry":[{"country_code":"EU","regulator":"EMA","status":"pending","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"CA","regulator":"Health Canada","status":"approved","approval_date":null,"mah":"","brand_name_local":"","application_number":""},{"country_code":"GB","regulator":"MHRA","status":"approved","approval_date":null,"mah":"","brand_name_local":null,"application_number":""},{"country_code":"US","regulator":"FDA","status":"approved","approval_date":null,"mah":null,"brand_name_local":null,"application_number":null}],"pricingByCountry":[{"country_code":"US","currency":"USD","price_amount":"80000.00","price_per":"year","price_type":"annual_list","annual_cost_usd":null,"reimbursement_status":null}],"trialStats":{"total":7,"withResults":6},"validation":{"fieldsValidated":3,"lastValidatedAt":"2026-04-20T08:28:36.585175+00:00","fieldsConflicting":0,"overallConfidence":0.95},"verificationStatus":"verified","dataCompleteness":{"mechanism":false,"indications":true,"safety":true,"trials":true,"score":3}}