Study on Sotagliflozin for Slowing Kidney Disease in Type 1 Diabetes Patients

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What is this study about?

This clinical trial is focused on studying the effects of a medication called sotagliflozin in people with Type 1 Diabetes Mellitus who also have chronic kidney complications. The purpose of the study is to understand how this medication might help in preventing the progression of chronic kidney disease (CKD) in these patients. Sotagliflozin is a type of drug known as a dual inhibitor of SGLT1 and SGLT2, which means it works by blocking certain proteins in the body that are involved in sugar absorption and kidney function.

Participants in the study will receive either sotagliflozin or a placebo, which is a tablet that looks like the medication but does not contain the active drug. The study will last for about three months, during which the effects of the medication on kidney health will be monitored. This will be done using a special imaging technique called MRI (Magnetic Resonance Imaging) to measure how well the kidneys are being supplied with oxygen. The goal is to see if sotagliflozin can improve kidney oxygenation compared to the placebo.

The study aims to provide valuable insights into how long-term use of sotagliflozin might help manage kidney health in people with Type 1 Diabetes and chronic kidney disease. By understanding these effects, researchers hope to find better ways to support kidney function and slow down the progression of kidney disease in these patients.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as having type 1 diabetes and chronic kidney disease with albuminuria.

2 initial assessment

An initial assessment is conducted to establish baseline health metrics. This may include various tests and measurements to understand current kidney function and overall health status.

3 medication administration

Participants receive either sotagliflozin or a placebo. Sotagliflozin is administered orally in the form of film-coated tablets.

The dosage is 200 mg, taken once daily for a duration of three months.

4 ongoing monitoring

Throughout the three-month period, regular monitoring occurs to track any changes in health status. This includes monitoring kidney function and other relevant health indicators.

5 final assessment

At the end of the three-month period, a final assessment is conducted. This includes measuring changes in kidney oxygenation using MRI technology, comparing results from the start and end of the trial.

6 completion of study

Upon completion of the study, participants are informed of their results and any potential next steps regarding their health management.

Who Can Join the Study?

  • Must be an adult with Type 1 Diabetes Mellitus. This is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
  • Must have Chronic Kidney Disease. This means the kidneys are not working as well as they should over a long period.
  • Must have albuminuria. This is a condition where there is a higher than normal amount of a protein called albumin in the urine, indicating kidney issues.
  • Both men and women can participate.

Who Cannot Join the Study?

  • Patients who do not have Type 1 Diabetes Mellitus with chronic kidney complications cannot participate. Type 1 Diabetes Mellitus is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
  • Patients who are not within the specified age range cannot participate. The age range for this study is not specified in the provided data.
  • Patients who are part of a vulnerable population cannot participate. A vulnerable population includes groups who may have limited ability to give informed consent or are at higher risk of harm.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name City Country Status
Steno Diabetes Center Copenhagen Herlev Denmark

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Denmark Denmark
Recruiting
01.08.2024

Trial locations

Investigated drugs:

Sotagliflozin is a medication being studied for its potential to help protect the kidneys in people with type 1 diabetes and chronic kidney disease. The trial is investigating how this medication affects kidney oxygen levels over a three-month period.

Investigated diseases:

Type 1 Diabetes Mellitus with chronic kidney complications – This condition is a form of diabetes where the body’s immune system attacks insulin-producing cells in the pancreas, leading to high blood sugar levels. Over time, the high blood sugar can cause damage to various organs, including the kidneys. Chronic kidney complications occur when the kidneys are unable to filter waste and excess fluids from the blood effectively. This can lead to a buildup of waste products in the body and may cause symptoms such as swelling, fatigue, and high blood pressure. The progression of kidney damage can vary, but it often worsens over time if blood sugar levels are not well controlled. Managing blood sugar and monitoring kidney function are crucial to slowing the progression of kidney complications in individuals with Type 1 Diabetes.

Trial ID:
2023-509450-55-01
NCT ID:
NCT06147232
Trial Phase:
Therapeutic exploratory (Phase II)

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