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SGLT2 Inhibitor

Sotagliflozin for Diabetic Kidney Disease (SUGARNSALT Trial)

Phase 3

Recruiting

Led By Alessandro Doria, MD PhD MPH

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

Must not have

Use of anti tumor necrosis factor (TNF) alpha biologic medications at 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

Timeline

Screening 3 weeks

Treatment Varies

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

Awards & highlights

Pivotal 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.

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.

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.

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.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am currently using anti-TNF alpha medications.

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I have had a severe diabetic complication in the last 3 months or more than once in the last year.

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I've had 3 or more severe low blood sugar events needing help in the last 3 months.

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I have a chronic kidney condition not caused by diabetes.

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I have a severe case of AIDS, HIV, or a very weak immune system.

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I have a history of sugar in my urine due to a kidney condition.

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I have had a kidney transplant or am on long-term dialysis.

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I have type 2 diabetes or a rare form of diabetes.

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I have not taken any SGLT inhibitor medications in the last 2 months.

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I am not pregnant, breastfeeding, and am willing to use contraception during the 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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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

Secondary study objectives

Time to ≥40% eGFR decline from baseline, kidney failure , or death from renal causes

Other study objectives

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

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

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 / 13Eligibility criteria met