Sotagliflozin to Slow Kidney Function Decline in Persons With Type 1 Diabetes and Diabetic Kidney Disease (SUGARNSALT)

Effectiveness and Safety of Sotagliflozin in Slowing Kidney Function Decline in Persons With Type 1 Diabetes and Moderate to Severe Diabetic Kidney Disease

Powerful new drugs that can prevent or delay end stage kidney disease (ESKD) - so called sodium-glucose cotransporter-2 inhibitors (SGLT2i) - are now available for patients with type 2 diabetes. Whether these drugs have similar effects in patients with type 1 diabetes (T1D) remains unknown because of the few studies in this population, due to concerns about the increase in risk of diabetic ketoacidosis (DKA, a serious, potentially fatal acute complication of diabetes due to the accumulation of substances called ketone bodies) observed with SGLT2i therapy in T1D. One of the few T1D studies conducted to date showed that implementing an enhanced DKA prevention plan can reduce the risk of DKA associated with the SGLT2i sotagliflozin (SOTA) to very low levels. In the present study, a similar DKA prevention program will be used to carry-out a 3-year trial to test the kidney benefit of SOTA in 150 persons with T1D and moderate to advanced DKD. After a 2-month period, during which diabetes care will be standardized and education on monitoring and minimizing DKA implemented, eligible study subjects will be randomly assigned (50/50) to take one tablet of SOTA (200 mg) or a similarly looking inactive tablet (placebo) every day for 3 years followed by 2-months without treatment. Neither the participants nor the study staff will know whether a person was assigned to taking SOTA or the inactive tablet. Kidney function at the end of the study will be compared between the two treatment groups to see whether SOTA prevented kidney function loss in those treated with this drug as compared to those who took the inactive tablet. The DKA prevention program will include participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body self-monitoring with a meter provided by the study. If successful, this study will provide efficacy and safety data that could be used to seek FDA approval of SOTA for the prevention of kidney function decline in patients with T1D and DKD.

Study Overview

• Status: Not yet recruiting
• Conditions: Heart Failure; Diabetic Nephropathies; Kidney Failure, Chronic; Diabetes Mellitus Type 1
• Intervention / Treatment: Drug: Sotagliflozin; Drug: Placebo

Detailed Description

Despite improvements in glycemia management and the use of renin-angiotensin system blockade (RASB), the overall incidence of ESKD incidence in the US T1D population is not decreasing. For patients with type 2 diabetes (T2D), powerful new drugs that can prevent or delay ESKD, sodium-glucose cotransporter-2 inhibitors (SGLT2i), are now available. Whether similar results can be achieved in T1D remains unknown because of the paucity of studies in this population, due to concerns about the 2- to 3-fold increase in risk of diabetic ketoacidosis (DKA) associated with SGLT2i therapy in T1D. One of the few T1D studies conducted to date (inTandem, a sotagliflozin [SOTA] trial), showed that implementation of an enhanced DKA risk monitoring and mitigation strategy can reduce DKA incidence to <1%/year in subjects on 200 mg/day of this dual SGLT1 and SGLT2 inhibitor. The goals of the present study are to evaluate the renal effectiveness of SGLT2i in T1D and to better understand the benefit/risk ratio of SOTA in T1D persons with moderate to advanced diabetic kidney disease (DKD) - two goals that are warranted and critical given the high risk of death and ESKD in this population. The study, carried out by the Preventing Early Renal Loss (PERL) and the Canadian Institute of Health Research (CIHR)-funded SUGARNSALT (S&S) consortia, is a multi-center, double-blind, placebo-controlled, parallel-group randomized clinical trial in 150 patients with T1D and moderate to advanced diabetic kidney disease (estimated glomerular filtration rate [eGFR] 20-60 ml/min/1.73 m2 and ACR>200 mg/g). After a 2-month run-in period, during which diabetes care is standardized and education on monitoring and minimizing DKA implemented, eligible study subjects are randomized in a 1:1 ratio to receive placebo or once daily 200 mg SOTA for 3 years followed by a 2-month wash-out period. The eGFR at the end of the wash-out adjusted by its baseline value will be used as the primary outcome on which SOTA efficacy on DKD progression will be evaluated. An intensive DKA risk mitigation plan will be implemented based on the inTandem enhanced protocol as well as on the STICH (Stop SGLT2i, Insulin administration, Carbohydrate intake, Hydration) and STOP-DKA protocols. Cornerstones of this plan will be enhanced participant education, close follow-up with study staff, continuous glucose monitoring, and systematic ketone body (beta-hydroxybutyrate [BHB]) self-monitoring. If successful, the present study will provide efficacy and safety data that could be used to seek FDA and Health Canada approval of SOTA for a T1D DKD indication. Based on the available data in T1D, it can be conservatively postulated that SOTA may reduce eGFR loss by 2 ml/min/1.73 m2 per year. Depending on the baseline eGFR, this would translate to a 5-10 year delay of ESKD. The reduction in morbidity and mortality resulting from the prevention or delay of ESKD due to the use of SOTA would have a major impact on the lives of T1D patients with significant DKD as well as on society at large, substantially reducing the human and financial costs associated with this condition.

• Study Type: Interventional
• Enrollment (Estimated): 150
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Christine Mendonca; Phone Number: 617-309-2735; Email: christine.mendonca@joslin.harvard.edu
• Study Contact Backup: Name: Emily Collins; Email: emily.collins@joslin.harvard.edu

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2T 5C7
      • Unversity of Calgary
      • Contact: Ronald Sigal, MD MPH; Email: rsigal@ucalgary.ca
      • Principal Investigator: Ronald Sigal, MD MPH
    • Edmonton, Alberta, Canada, T6G 2E1
      • Alberta Diabetes Institute
      • Contact: Peter Senior, MD; Email: psenior@ualberta.ca
      • Principal Investigator: Peter Senior, MD
  • British Columbia
    • Vancouver, British Columbia, Canada, V6Z 1Y6
      • St. Paul's Hospital
      • Contact: Adeera Levin, MD; Email: alevin@providencehealth.bc.ca
      • Principal Investigator: Adeera Levin, MD
  • Ontario
    • Toronto, Ontario, Canada, M4G 3E8
      • LMC Diabetes and Endocrinology
      • Contact: Ronnie Aronson, MD; Email: Ronnie.Aronson@LMC.CA
      • Principal Investigator: Ronnie Aronson, MD
    • Toronto, Ontario, Canada, M5G 2C4
      • Mount Sinai Hospital / University of Toronto
      • Contact: Andrej Orszag; Phone Number: 7625 416-586-4800; Email: PERLstudy@lunenfeld.ca
      • Principal Investigator: Bruce Perkins, MD, MPH
    • Toronto, Ontario, Canada, M5G 2N2
      • Toronto General Hospital
      • Contact: Andrej Orszag; Phone Number: 7625 416-586-4800; Email: andrej.orszag@uhn.ca
      • Contact: Phone Number: 7187 416-586-4800
      • Principal Investigator: David Cherney, MD
  • Quebec
    • Montreal, Quebec, Canada, H2W 1R7
      • Institut de Recherches Cliniques de Montreal
      • Contact: Remi Rabasa-Lhoret, MD; Email: remi.rabasa-lhoret@ircm.qc.ca
      • Principal Investigator: Remi Rabasa-Lhoret, MD
• United States
  • California
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
      • Principal Investigator: Marina Basina, MD
      • Contact: Marina Basina, MD; Email: mbasina@stanford.edu
      • Sub-Investigator: David Maahs, MD
  • Colorado
    • Aurora, Colorado, United States, 80045
      • Barbara Davis Center / University of Colorado Denver
      • Principal Investigator: Sarit Polsky, MD
      • Contact: Sarit Polsky, MD; Email: SARIT.POLSKY@CUANSCHUTZ.EDU
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine
      • Principal Investigator: Amisha Wallia, MD
      • Contact: Amisha Wallia, MD; Email: a-wallia@northwestern.edu
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Joslin Diabetes Center
      • Contact: Christine Mendonca; Phone Number: 617-309-2735; Email: christine.mendonca@joslin.harvard.edu
      • Principal Investigator: Alessandro Doria, MD PhD MPH
      • Sub-Investigator: Sylvia Rosas, MD
      • Sub-Investigator: Elena Toschi, MD
  • Michigan
    • Ann Arbor, Michigan, United States, 48105
      • Brehm Center for Diabetes Research / University of Michigan
      • Principal Investigator: Rodica Pop-Busui, MD, PhD
      • Contact: Rodica Pop-Busui, MD, PhD; Email: rpbusui@med.umich.edu
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
      • Contact: Janet McGill, MD; Email: jmcgill@wustl.edu
      • Principal Investigator: Janet McGill, MD
  • New York
    • Bronx, New York, United States, 10461
      • Albert Einstein College of Medicine / Montefiore Medical Center
      • Principal Investigator: Matthew Abramowitz, MD
      • Contact: Matthew Abramowitz, MD; Email: matthew.abramowitz@einsteinmed.edu
      • Sub-Investigator: Jill Crandall, MD
    • Syracuse, New York, United States, 13210
      • SUNY Upstate Medical University
      • Principal Investigator: Ruth Weinstock, MD
      • Contact: Jane Bulger, MS, CCRC; Phone Number: 315-464-9008; Email: BulgerJ@upstate.edu
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Foundation
      • Contact: Luiza Caramori, MD PhD; Email: CARAMOM@ccf.org
      • Principal Investigator: Luiza Caramori, MD PhD
  • Texas
    • Dallas, Texas, United States, 75390
      • University of Texas Southwestern
      • Contact: Ildiko Lingvay, MD; Email: Ildiko.Lingvay@UTSouthwestern.edu
      • Principal Investigator: Ildiko Lingvay, MD
  • Washington
    • Seattle, Washington, United States, 98105
      • University of Washington
      • Contact: Ian de Boer, MD; Email: deboer@uw.edu
      • Principal Investigator: Ian de Boer, MD
      • Sub-Investigator: Irl Hirsch, MD
    • Spokane, Washington, United States, 99204
      • Providence Sacred Heart Medical Center
      • Contact: Katherine Tuttle, MD; Email: Katherine.Tuttle@providence.org
      • Contact: RDN
      • Principal Investigator: Katherine R. Tuttle, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Type1 diabetes (T1D) continuously treated with insulin within one year from diagnosis.
• Duration of T1D ≥ 8 years;
• eGFR based on serum creatinine between 20 and 60 ml/min/1.73 m2 at screening;
• First morning void urinary albumin/creatinine ratio (UACR) ≥200 mg/g at screening;
• HbA1c <10% at screening;
• Receiving standard of care, including renin angiotensin system blockade (RASB), unless contraindicated or not tolerated.
• Willing and able to comply with schedule of events and protocol requirements, including written informed consent, and willing to wear a continuous glucose monitoring (CGM) device for the entire duration of the study.

Exclusion Criteria:

• Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease;
• Use of non-FDA approved automated insulin delivery devices;
• Use of any SGLT inhibitor in the previous 2 months;
• Use of glucagon-like peptide (GLP-1) receptor agonists and other non-insulin glucose lowering agents if in use for less than 3 months and/or not on stable dose at screening;
• Use of anti tumor necrosis factor (TNF) alpha biologic medications at screening;
• Known allergies, hypersensitivity, or intolerance to SOTA;
• History of ≥3 severe hypoglycemic events (requiring third-party assistance for correction) within 3 months of screening;
• History of diabetic ketoacidosis (DKA) or non-ketotic hyperosmolar state within 3 months of screening OR >1 episode of DKA or non-ketotic hyperosmolar state within 12 months of screening;
• Blood beta-hydroxybutyrate (BHB) >0.6 mmol/L for >2 hours on >2 occasions during the Run-in period;
• Inadequate beta hydroxybutyrate (BHB) testing (<50% of the prescribed measurements) during Run-in;
• History of primary renal glycosuria;
• History of biopsy-proven non-diabetic chronic kidney disease (CKD);
• History of renal transplant or currently on chronic dialysis;
• Current or past history of decompensated cirrhosis (defined as variceal bleeding, ascites or hepatic encephalopathy), and/or known diagnosis of cirrhosis based on liver biopsy, imaging, or elastography, and/or aspartate aminotransferase (AST) or alanine transaminase (ALT) at screening >2 times upper limit of normal, and/or total bilirubin at screening >1.3 times upper limit of normal).
• History of severe acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection or severely immunocompromised status;
• Cancer treatment (excluding non-melanoma skin cancer treated by excision, carcinoma in situ of the cervix or uterus, ductal breast cancer in situ, resected non-metastatic breast or prostate cancer) within one year of screening.
• Illicit drug abuse within 6 months of screening;
• Heavy alcohol use (for men, 5 drinks or more on any day or 15 drinks or more per week; for women, 4 drinks or more on any day or 8 drinks or more per week);
• Participation in another interventional clinical research study within 30 days of screening;
• Breastfeeding, pregnancy, or unwillingness to be on contraception during the trial;
• Systolic blood pressure >155 mmHg or diastolic blood pressure >95 mmHg at screening;
• Presence of a clinically significant medical history, physical examination, or laboratory finding that may interfere with any aspect of study conduct or interpretation of results;
• Any condition that may render the patient unable to comply with study requirements and/or complete the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Sotagliflozin; Oral sotagliflozin at a dose of 200 mg (one tablet) per day for three years followed by a 2-month wash-out period.	Drug: Sotagliflozin; Oral sotagliflozin (200 mg per day); Other Names: INPEFA
Placebo Comparator: Placebo; Oral tablets similar to sotagliflozin tablets but containing no active drug (one tablet per day for three years followed by a 2-month wash-out period).	Drug: Placebo; Inactive tablets identical to sotagliflozin tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
eGFR at the end of the wash-out period following the treatment period	eGFR at the end of the 8-week drug washout period following the 3-year treatment period, estimated from Central Lab serum creatinine and cystatin C using the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation and adjusted by its baseline value. Baseline and end-of-washout eGFRs will be considered as the average of two eGFR values taken on two separate days before randomization (V2 and V4) and after the washout (V18 and V19), respectively.	End of the 2-month wash-out period following the 3-year treatment period (weeks 162 and 164)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to ≥40% eGFR decline from baseline, end-stage kidney disease, renal replacement therapy, or death from renal causes	Time from randomization to ≥40% eGFR decline (based on eGFR estimated from serum creatinine and cystatin C using the 2021 CKD-EPI equation) confirmed after 30 days, ESKD defined by eGFR ≤10ml/min/ 1.73m2 confirmed after 30 days, renal replacement therapy, or death from renal causes.	Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary albumin excretion rate change from baseline equal to or more negative than -30% at the end of treatment	Urinary albumin excretion rate (UAER, timed overnight collection) change from baseline equal to or more negatvive than -30% at the end of treatment (determined from the geometric mean of two UAER measurements in timed overnight urine collections during the last 3 months of the treatment period [Visits 16 and 17])	Last three months of treatment period (Weeks 142 and 156).
Urinary albumin excretion rate change from baseline equal to or more negative than -30% at the end of the washout period	UAER change from baseline equal to or more negative than -30% at the end of the 8-week washout period following the 3-year treatment period (determined from the geometric mean of two UAER measurements in timed overnight urine collections brought by the participant at visit 19).	End of the 2-month wash-out period following the 3-year treatment period (week 164)
eGFR slope during the treatment period	eGFR slope from baseline to the end of the 3-yr treatment period (before the washout period), ESKD, death, or study discontinuation, whichever occurs first	Weeks 0, 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)
eGFR at the end of the 3-yr treatment period	eGFR at the end of the 3-yr treatment period (before the washout period) adjusted for the baseline value	End of the 3-year treatment period (week 156)
Time to fatal or non-fatal cardiovascular disease (CVD) events	Time to fatal or non-fatal CVD events (CV death, non-fatal myocardial infarction, non-fatal stroke, or coronary, carotid, or peripheral revascularization procedures)	Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164)
Time to hospitalization or urgent visit for heart failure or CV death	Time to hospitalization or urgent visit for heart failure or death for cardiovascular causes	Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164)
Time to hospitalization for heart failure	Time to hospitalization for heart failure	Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164)
B-type natriuretic peptide (NTproBNP) serum levels at the end of the drug washout	Serum levels of NTproBNP at the end of the 8-week drug washout, adjusted for its baseline value	End of the 2-month wash-out period following the 3-year treatment period (week 164)
High-sensitivity cardiac troponin (hs-cTnT) serum levels at the end of the drug washout	Serum levels of hs-cTnT at the end of the 8-week drug washout, adjusted for its baseline value	End of the 2-month wash-out period following the 3-year treatment period (week 164)
NTproBNP serum levels at the end of the treatment period	Serum levels of B-type natriuretic peptide (NTproBNP) at the end of the 3-year treatment period, adjusted for its baseline value	End of the 3-year treatment period (week 156)
hs-cTnT serum levels at the end of the treatment period	Serum levels of high-sensitivity cardiac troponin (hs-cTnT ) at the end of the 3-year treatment period, adjusted for its baseline value	End of the 3-year treatment period (week 156)
Mean blood HbA1c levels during the treatment period	Mean HbA1c during the 3-year treatment period	Weeks 0, 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)
Mean blood glucose levels during the treatment period	Mean blood glucose from continuous glucose monitoring during the 3-year treatment period	Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)
Mean GMI during the treatment period	Mean glucose management indicator (GMI) from continuous glucose monitoring during the 3-year treatment period	Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)
Mean time in range (TIR) during the treatment period	Mean time with blood glucose in the 70 to 180 mg /dl range from continuous glucose monitoring during the 3-year treatment period	Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)
Mean time below range 70 (TBR70) during the treatment period	Mean time with blood glucose below 70 mg/dl from continuous glucose monitoring during the 3-year treatment period	Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)
Mean time below range 54 (TBR54) during the treatment period	Mean time with blood glucose below 54 mg/dl from continuous glucose monitoring during the 3-year treatment period	Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)
Mean time above range 180 (TAR180) during the treatment period	Mean time with blood glucose above 180 mg/dl from continuous glucose monitoring during the 3-year treatment period	Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)
Mean time above range 250 (TAR250) during the treatment period	Mean time with blood glucose above 250 mg/dl from continuous glucose monitoring during the 3-year treatment period	Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)
Mean Glucose CV during the treatment period	Mean blood glucose coefficient of variation (CV) from continuous glucose monitoring during the 3-year treatment period	Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)
Mean MAGE during the treatment period	Mean amplitude of glycemic excursions (MAGE) from continuous glucose monitoring during the 3-year treatment period	Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)
Mean GRI during the treatment period	Mean glycemic risk index (GRI) from continuous glucose monitoring during the 3-year treatment period	Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)
Mean total daily insulin dose during the treatment period	Mean total daily insulin dose (TDD, units/kg) during the 3-year treatment period	Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)

Collaborators and Investigators

• Sponsor: Alessandro Doria
• Collaborators: University of Colorado, Denver; University Health Network, Toronto; University of British Columbia; Washington University School of Medicine; Northwestern University; Juvenile Diabetes Research Foundation; Canadian Institutes of Health Research (CIHR); University of Michigan; The Cleveland Clinic; Montefiore Medical Center; University of Alberta; University of Washington; Stanford University; University of Toronto; State University of New York - Upstate Medical University; University of Minnesota; University of Calgary; Lexicon Pharmaceuticals; Institut de Recherches Cliniques de Montreal; DexCom, Inc.; Joslin Diabetes Center; The Kidney Foundation of Canada; Providence Medical Research Center; LMC Diabetes & Endocrinology Ltd.
• Investigators: Principal Investigator: Alessandro Doria, MD PhD MPH, Joslin Diabetes Center; Principal Investigator: Michael Mauer, MD, University of Minnesota; Principal Investigator: David Cherney, MD PhD, University of Toronto

Publications and helpful links

General Publications

• Bhatt DL, Szarek M, Steg PG, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Voors AA, Metra M, Lund LH, Komajda M, Testani JM, Wilcox CS, Ponikowski P, Lopes RD, Verma S, Lapuerta P, Pitt B; SOLOIST-WHF Trial Investigators. Sotagliflozin in Patients with Diabetes and Recent Worsening Heart Failure. N Engl J Med. 2021 Jan 14;384(2):117-128. doi: 10.1056/NEJMoa2030183. Epub 2020 Nov 16.
• Bhatt DL, Szarek M, Pitt B, Cannon CP, Leiter LA, McGuire DK, Lewis JB, Riddle MC, Inzucchi SE, Kosiborod MN, Cherney DZI, Dwyer JP, Scirica BM, Bailey CJ, Diaz R, Ray KK, Udell JA, Lopes RD, Lapuerta P, Steg PG; SCORED Investigators. Sotagliflozin in Patients with Diabetes and Chronic Kidney Disease. N Engl J Med. 2021 Jan 14;384(2):129-139. doi: 10.1056/NEJMoa2030186. Epub 2020 Nov 16.
• van Raalte DH, Bjornstad P, Persson F, Powell DR, de Cassia Castro R, Wang PS, Liu M, Heerspink HJL, Cherney D. The Impact of Sotagliflozin on Renal Function, Albuminuria, Blood Pressure, and Hematocrit in Adults With Type 1 Diabetes. Diabetes Care. 2019 Oct;42(10):1921-1929. doi: 10.2337/dc19-0937. Epub 2019 Aug 1.
• Markham A, Keam SJ. Sotagliflozin: First Global Approval. Drugs. 2019 Jun;79(9):1023-1029. doi: 10.1007/s40265-019-01146-5.

Study record dates

Study Major Dates

• Study Start (Estimated): May 1, 2024
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 9, 2024
• First Submitted That Met QC Criteria: January 18, 2024
• First Posted (Actual): January 22, 2024

Study Record Updates

• Last Update Posted (Actual): January 22, 2024
• Last Update Submitted That Met QC Criteria: January 18, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Cardiovascular disease; Heart failure; Type 1 diabetes; Kidney Failure, Chronic; Diabetic Nephropathies; Glomerular filtration rate; Diabetic kidney disease; SGLT2 inhibitors
• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Urologic Diseases; Endocrine System Diseases; Disease Attributes; Diabetes Complications; Renal Insufficiency, Chronic; Chronic Disease; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Heart Failure; Diabetes Mellitus; Kidney Diseases; Diabetes Mellitus, Type 1; Diabetic Nephropathies; Kidney Failure, Chronic; Renal Insufficiency; Hypoglycemic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Sodium-Glucose Transporter 2 Inhibitors; (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol
• Other Study ID Numbers: STUDY00000249

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No