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

March 20, 2026 updated by: Alessandro Doria

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2T 5C7
      • Edmonton, Alberta, Canada, T6G 2E1
        • Recruiting
        • Alberta Diabetes Institute
        • Principal Investigator:
          • Peter Senior, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Anna Lam, MD
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 1Y6
        • Recruiting
        • St. Paul's Hospital
        • Principal Investigator:
          • Adeera Levin, MD
        • Sub-Investigator:
          • Sean Barbour, MD
        • Contact:
    • Ontario
      • Toronto, Ontario, Canada, M5G 2N2
        • Recruiting
        • Toronto General Hospital
        • Principal Investigator:
          • David Cherney, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Bruce Perkins, MD MPH
        • Sub-Investigator:
          • Vikas S. Sridhar, MD
        • Sub-Investigator:
          • Ayodele Odutayo, MD
        • Sub-Investigator:
          • Huajing Ni, MD
        • Sub-Investigator:
          • Taewon Yi, MD
      • Toronto, Ontario, Canada, M4G 3E8
    • Quebec
      • Montreal, Quebec, Canada, H2W 1R7
        • Recruiting
        • Institut de recherches cliniques de Montréal
        • Principal Investigator:
          • Remi Rabasa-Lhoret, MD
        • Contact:
        • Sub-Investigator:
          • Nadine Taleb, MD
        • Contact:
  • United States
    • California
      • Stanford, California, United States, 94305
        • Recruiting
        • Stanford University Medical Center
        • Principal Investigator:
          • Marina Basina, MD
        • Sub-Investigator:
          • David Maahs, MD
        • Contact:
        • Contact:
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Orlando, Florida, United States, 32803
    • Illinois
    • Massachusetts
      • Boston, Massachusetts, United States, 02215
        • Recruiting
        • Joslin Diabetes Center
        • Principal Investigator:
          • Alessandro Doria, MD PhD MPH
        • Sub-Investigator:
          • Sylvia Rosas, MD
        • Sub-Investigator:
          • Elena Toschi, MD
        • Contact:
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Washington University
        • Principal Investigator:
          • Janet McGill, MD
        • Sub-Investigator:
          • Kai Jones, MD
        • Sub-Investigator:
          • Maamoun Salam, MD
        • Sub-Investigator:
          • Huda Al-Bahadili, MD
        • Contact:
    • New York
      • Syracuse, New York, United States, 13210
        • Recruiting
        • SUNY Upstate Medical University
        • Principal Investigator:
          • Ruth Weinstock, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Malek El Muayed, MD, MSCI
        • Sub-Investigator:
          • Katherine McPhee, MSN, FNP-C, RN
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Albert Einstein College of Medicine / Montefiore Medical Center
        • Principal Investigator:
          • Matthew Abramowitz, MD
        • Sub-Investigator:
          • Jill Crandall, MD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Justin Mathew, MD
    • Ohio
      • Cleveland, Ohio, United States, 44195
        • Recruiting
        • Cleveland Clinic Foundation
        • Principal Investigator:
          • Luiza Caramori, MD PhD
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Keren Zhou, MD
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Principal Investigator:
          • Rodica Busui, MD, PhD
        • Contact:
        • Sub-Investigator:
          • Andrew Ahmann, MD
        • Contact:
    • Texas
    • Washington
      • Seattle, Washington, United States, 98105
        • Recruiting
        • University of Washington
        • Principal Investigator:
          • Petter Bjornstad, MD
        • Sub-Investigator:
          • Irl Hirsch, MD
        • Contact:
        • Sub-Investigator:
          • Ian de Boer, MD
        • Sub-Investigator:
          • Kalie Tommerdahl, MD
        • Contact:
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Providence Sacred Heart Medical Center
        • Principal Investigator:
          • Katherine R. Tuttle, MD
        • Contact:
        • Sub-Investigator:
          • Radica Alicic, MD
        • Sub-Investigator:
          • Michael Ryan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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 and cystatin c (2021 serum creatinine-cystatin C CKD-EPI equation) between 20 and 60 ml/min/1.73 m2 at screening (with the option of a second eGFR measurement within 4 weeks from the first one if the eGFR was in the range of >60 to ≤65 or ≥16 to <20 ml/min/1.73 m2);
  • a. First morning void urinary albumin creatinine ratio (UACR) ≥200 mg/g at Screening or on repeat measurement within 4 weeks from the first one, or b. First morning void urinary UACR ≥100 mg/g at Screening or on repeat measurement within 4 weeks and at least one uACR >=30 in the previous 2 years while treated with RASB at a stable dose;
  • HbA1c at screening <10% (with the option of a second HbA1c measurement within 4 weeks from the first one if the HbA1c was ≤10.2%);
  • Receiving standard of care, including renin angiotensin system blockers (RASB) at a clinically appropriate dose, 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.
  • a. Blood pressure ≤155/95 mmHg at screening, or b. BP ≤155/95 mmHg at the end of the run-in period, or c. consistent BP ≤155/95 mmHg on home monitoring during the run-in period, as determined by study site investigator, despite BP values >155/95 mmHg in clinic.

Exclusion Criteria:

  • Type 2 diabetes or monogenic forms of diabetes or diabetes secondary to pancreatic disease;
  • Use of automated insulin delivery devices that are not approved by health regulatory agencies, or used in ways that do not align with manufacturer recommendations;
  • Use of any SGLT inhibitor in the previous 2 months;
  • Use of dual medication RASB therapy (spironolactone, eplerenone, finerenone are allowed in combination with RASB therapy);
  • Use of GLP-1 receptor agonists and other non-insulin glucose-lowering agents if not on stable dose for > 2 months at screening (patients can be rescreened after being on stable dose for > 2 months);
  • 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 kidney 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;
  • 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
eGFR at the end of the wash-out period following the treatment period
Time Frame: End of the 2-month wash-out period following the 3-year treatment period (weeks 162 and 164)
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Time to ≥40% eGFR decline from baseline, kidney failure , or death from renal causes
Time Frame: Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164)
Time from randomization to 1. sustained ≥40% eGFR decline (based on eGFR estimated from serum creatinine and cystatin C using the 2021 CKD-EPI equation) confirmed after 30 days; 2. kidney failure, defined by eGFR ≤10ml/min/ 1.73m2 confirmed after 30 days or occurring within 30 days prior to death, or initiation of maintenance kidney replacement therapy; or 3. death from kidney-related causes. If an eGFR value meeting the above criteria is observed at the last study visit or immediately before a participant is lost to follow-up or withdraws from the study, no confirmation of this value will be necessary.
Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164)

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
eGFR at the end of the 3-yr treatment period
Time Frame: End of the 3-year treatment period (week 156)
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 Frame: Up to the end of the 2-month wash-out period following the 3-year treatment period (week 0 to 164)
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 Frame: 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 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 Frame: 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
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
Time Frame: End of the 2-month wash-out period following the 3-year treatment period (week 164)
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
Time Frame: End of the 2-month wash-out period following the 3-year treatment period (week 164)
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
Time Frame: End of the 3-year treatment period (week 156)
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
Time Frame: End of the 3-year treatment period (week 156)
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
Time Frame: Weeks 0, 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of 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
Time Frame: Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of 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
Time Frame: Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of 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
Time Frame: Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of 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
Time Frame: Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of 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
Time Frame: Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of 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
Time Frame: Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of 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
Time Frame: Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of 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
Time Frame: Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of 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
Time Frame: Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of 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
Time Frame: Weeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of 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
Time Frame: 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 (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)
Urinary albumin excretion rate change from baseline equal to or more negative than -30% at the end of treatment
Time Frame: End of treatment period (Week 156).
Urinary albumin excretion rate (UAER, timed overnight collection) reduction from baseline ≥30% at the end of treatment;
End of treatment period (Week 156).
Urinary albumin excretion rate change from baseline equal to or more negative than -30% at the end of the washout period
Time Frame: End of the 2-month wash-out period following the 3-year treatment period (week 164)
Urinary albumin excretion rate (UAER) reduction from baseline ≥30% at the end of the 8-week washout period following the 3-year treatment period;
End of the 2-month wash-out period following the 3-year treatment period (week 164)
eGFR slope during the treatment period
Time Frame: Weeks 0, 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)
eGFR slope from baseline to the end of the 3-yr treatment period (before the washout period), kidney failure, 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alessandro Doria

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Colorado, Denver
University Health Network, Toronto
University of British Columbia
Washington University School of Medicine
Northwestern University
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 Calgary
Lexicon Pharmaceuticals
AdventHealth
Institut de Recherches Cliniques de Montreal
DexCom, Inc.
Joslin Diabetes Center
The Kidney Foundation of Canada
Providence Medical Research Center
LMC Diabetes & Endocrinology Ltd.
Breakthrough T1D

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 31, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 9, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 18, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 22, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 20, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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