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SGLT2 Inhibitor

Sotagliflozin for Type 1 Diabetes (SUGARNSALT Trial)

Phase 3

Waitlist Available

Led By David Cherney, MD PhD

Research Sponsored by Alessandro Doria

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Type1 diabetes (T1D) continuously treated with insulin within one year from diagnosis

eGFR based on serum creatinine between 20 and 60 ml/min/1.73 m2 at screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up end of the 3-year treatment period (week 156)

Awards & highlights

SUGARNSALT Trial Summary

This trial aims to test the effects of a new drug called SOTA on kidney function in people with type 1 diabetes and moderate to advanced kidney disease. Previous studies have shown that SOTA can increase

Who is the study for?

This trial is for people with Type 1 Diabetes who also have moderate to advanced diabetic kidney disease. Participants should be willing to follow a strict program to prevent diabetic ketoacidosis, including education and regular monitoring. Those at risk of DKA or unable to adhere to the prevention plan are excluded.Check my eligibility

What is being tested?

The study tests if Sotagliflozin can slow down kidney function decline in Type 1 Diabetes patients with kidney disease. Half will receive Sotagliflozin; the other half a placebo, randomly assigned. The trial includes a DKA prevention program and spans over three years plus two months without treatment.See study design

What are the potential side effects?

Sotagliflozin may increase the risk of diabetic ketoacidosis (DKA), which is serious and potentially fatal if not managed properly. The trial includes measures to minimize this risk through participant education and close monitoring.

SUGARNSALT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have been on insulin since my Type 1 diabetes diagnosis.

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My kidney function, measured by eGFR, is between 20 and 60.

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I have had Type 1 Diabetes for 8 years or more.

SUGARNSALT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ end of the 3-year treatment period (week 156)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~end of the 3-year treatment period (week 156)

This trial's timeline: 3 weeks for screening, Varies for treatment, and end of the 3-year treatment period (week 156) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

eGFR at the end of the wash-out period following the treatment period

Secondary outcome measures

Time to ≥40% eGFR decline from baseline, end-stage kidney disease, renal replacement therapy, or death from renal causes

Other outcome measures

B-type natriuretic peptide (NTproBNP) serum levels at the end of the drug washout

High-sensitivity cardiac troponin (hs-cTnT) serum levels at the end of the drug washout

Mean GMI during the treatment period

+20 more

SUGARNSALT Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: SotagliflozinActive Control1 Intervention

Oral sotagliflozin at a dose of 200 mg (one tablet) per day for three years followed by a 2-month wash-out period.

Group II: PlaceboPlacebo Group1 Intervention

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).

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stanford UniversityOTHER

2,387 Previous Clinical Trials

17,333,900 Total Patients Enrolled

University of CalgaryOTHER

791 Previous Clinical Trials

868,584 Total Patients Enrolled

University of MinnesotaOTHER

1,378 Previous Clinical Trials

1,588,359 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Am I eligible to participate in this medical research study?

"Individuals aged between 18 and 75, diagnosed with type 1 diabetes, are eligible to participate in this study. A total of 150 participants will be recruited for the trial."

Answered by AI

Are potential participants currently able to join this research study?

"According to the current data on clinicaltrials.gov, this specific study is not actively seeking participants. The trial was originally posted on May 1st, 2024 and underwent its most recent update on January 18th, 2024. However, it's worth noting that there are currently over 2,528 other studies actively recruiting participants at this time."

Answered by AI

Has the FDA officially granted approval for Sotagliflozin to be used in medical treatment?

"Based on our assessment at Power, the safety of Sotagliflozin is rated as 3 on a scale from 1 to 3. This rating is attributed to it being a Phase 3 trial, indicating that there is existing evidence supporting its effectiveness and numerous rounds of data affirming its safety profile."

Answered by AI

Is this medical research being conducted across multiple hospitals within the city?

"Presently, this clinical trial is underway at 19 different sites. These sites are dispersed across various locations including Dallas, Stanford, Aurora, and several others. It is highly recommended that participants choose a clinic in close proximity to their residence to minimize travel obligations if they decide to enroll."

Answered by AI