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A study testing dapagliflozin and SC0062 together compared to SC0062 alone in adults with type 1 diabetes and chronic kidney disease

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study involves adults with Type 1 Diabetes and Chronic Kidney Disease. Type 1 Diabetes is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels. Chronic Kidney Disease means the kidneys are not working as well as they should and have difficulty filtering waste from the blood. The study will use two medications: dapagliflozin, which is given as a 5 mg tablet taken by mouth, and SC0062, which is given as a capsule taken by mouth. Dapagliflozin is a medication that helps the kidneys remove extra sugar from the body through urine. SC0062 works by blocking certain receptors in the body that can affect kidney function and fluid balance.

The purpose of this study is to examine how dapagliflozin and SC0062 work together compared to SC0062 alone in reducing the amount of a protein called albumin in the urine. When kidneys are damaged, they may leak albumin into the urine, and measuring this can show how well the kidneys are functioning. The study will also look at changes in body weight, blood pressure, kidney filtering ability, and markers that indicate fluid retention in the body. Additionally, the study will monitor any side effects that occur during treatment with these medications.

This is a crossover study, which means participants will receive different treatment combinations during different periods of the study. Each treatment period will last for 8 weeks. During the study, participants will take either SC0062 alone or a combination of both dapagliflozin and SC0062. Participants will need to continue managing their diabetes with insulin and monitoring their blood sugar levels at home as they normally do. Throughout the study, regular check-ups will be conducted to measure urine albumin levels, kidney function, and overall health to see how the treatments are working.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening and consent

    Your eligibility for the trial will be confirmed based on specific criteria. This includes having type 1 diabetes for at least 6 months and chronic kidney disease with specific levels of protein in your urine.

    Your HbA1c level (a measure of average blood sugar over the past 2-3 months) must be between 6.5% and 10.5%.

    Your eGFR (estimated glomerular filtration rate, a measure of kidney function) must be between 30 and 90 ml/min/1.73m2.

    Your urine albumin-to-creatinine ratio (a measure of protein in urine) must be between 50 mg/g and 3000 mg/g.

    You must have been on stable medication that affects the renin-angiotensin-aldosterone system (medications that help control blood pressure and protect the kidneys) for at least 4 weeks before screening.

    If you are a woman of childbearing potential, a pregnancy test will be performed and must be negative. You must not be breastfeeding.

    Both male and female participants must use highly effective contraception methods during the trial and for 4 weeks after the last dose of study medication.

  2. Step 2

    Baseline assessment

    Initial measurements will be taken to establish your starting point. These measurements will include your urine albumin-to-creatinine ratio, body weight, blood pressure, and eGFR.

    Blood samples will be collected to measure hemoglobin (a protein in red blood cells that carries oxygen) and NT-proBNP (a marker that indicates how well your heart is functioning).

    Your extracellular volume (the amount of fluid outside your cells) will be measured.

  3. Step 3

    First treatment period

    You will be randomly assigned to receive one of two treatment combinations during this period.

    One treatment option is SC0062 alone, which is an endothelin receptor antagonist (a medication that helps relax blood vessels and may protect the kidneys). This medication is taken orally as a hard capsule.

    The other treatment option is a combination of dapagliflozin and SC0062. Dapagliflozin is an SGLT2 inhibitor (a medication that helps the kidneys remove sugar from the blood through urine and may protect the kidneys). Dapagliflozin is available as Forxiga 5 mg film-coated tablets and is taken orally.

    The specific dosage, frequency, and duration of this treatment period will be determined by the trial protocol.

  4. Step 4

    Monitoring during first treatment period

    Throughout this treatment period, regular assessments will be conducted to monitor your response to the medication.

    These assessments will include measurements of your urine albumin-to-creatinine ratio, body weight, blood pressure, and eGFR.

    Blood samples will be collected to measure hemoglobin and NT-proBNP.

    Your extracellular volume will be measured.

    Any side effects or adverse events will be recorded and assessed for severity and seriousness.

  5. Step 5

    Crossover to second treatment period

    After completing the first treatment period, you will switch to the other treatment combination. This is called a crossover design.

    If you received SC0062 alone during the first period, you will now receive the combination of dapagliflozin and SC0062.

    If you received the combination of dapagliflozin and SC0062 during the first period, you will now receive SC0062 alone.

    The specific dosage, frequency, and duration of this treatment period will be determined by the trial protocol.

  6. Step 6

    Monitoring during second treatment period

    Throughout this treatment period, the same regular assessments will be conducted as during the first treatment period.

    These assessments will include measurements of your urine albumin-to-creatinine ratio, body weight, blood pressure, and eGFR.

    Blood samples will be collected to measure hemoglobin and NT-proBNP.

    Your extracellular volume will be measured.

    Any side effects or adverse events will be recorded and assessed for severity and seriousness.

  7. Step 7

    End of treatment and follow-up

    After completing both treatment periods, final assessments will be conducted.

    These final assessments will include the same measurements as during the treatment periods to evaluate the overall effects of the medications.

    You will be monitored for any side effects for 4 weeks after taking the last dose of study medication.

    If you are using contraception, you must continue to do so for 4 weeks after the last dose of study medication.

Who can join the trial?

15 criteria

  • You must be willing and able to sign an informed consent, which is a document that explains the study and confirms you agree to participate
  • You must be taking stable RAAS inhibition medication, which are medicines that help protect your kidneys and control blood pressure, for at least 4 weeks before joining the study
  • Your HbA1c level must be between 6.5% and 10.5%. HbA1c is a blood test that shows your average blood sugar levels over the past 2 to 3 months
  • You must have a good understanding of your diabetes and how to manage it, including being able to adjust your insulin therapy, which is the treatment using insulin to control blood sugar
  • You must be able to adjust insulin doses for meals, such as by counting carbohydrates, which are nutrients in food that affect blood sugar
  • You must perform regular blood sugar monitoring at home
  • You must have an established plan for managing your diabetes on days when you are sick
  • You must have been diagnosed with type 1 diabetes at least 6 months before joining the study
  • If you are a woman who can become pregnant, you must have a negative pregnancy test before starting the study and must not be breastfeeding
  • If you are a man, you must use a highly effective method of contraception, which is birth control, during the study and for 4 weeks after the last dose of study medicine, or provide proof of vasectomy, which is a permanent birth control procedure
  • If you are a woman, you must use a highly effective method of contraception during the study and for 4 weeks after the last dose of study medicine, or provide proof of hysterectomy, which is surgical removal of the uterus, or sterilization, which is a permanent birth control procedure, or be in menopause, which is confirmed by a hormone test
  • You must be at least 18 years old and younger than 65 years old when you sign the consent form
  • Your Body Mass Index must be 21 or higher. Body Mass Index is a measurement that uses your height and weight to estimate body fat
  • Your urinary albumin to creatinine ratio must be between 50 and 3000 mg/g. This test measures the amount of albumin, which is a protein, in your urine compared to creatinine, and shows how well your kidneys are working
  • Your eGFR must be between 30 and 90 ml/min/1.73m2. eGFR stands for estimated glomerular filtration rate, which is a measure of how well your kidneys are filtering waste from your blood

Who cannot join the trial?

4 criteria

  • The study information provided does not list specific reasons why patients cannot participate in this clinical trial
  • If you are interested in this study, the research team will review your complete medical history to determine if you are eligible to participate
  • Generally, clinical trials have specific requirements about other health conditions, medications you are taking, and test results that must be met for participation
  • The decision about whether you can join will be made after a thorough review of your individual health situation
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Investigated drugs

  • Dapagliflozin

    is a medication that helps the kidneys remove sugar from the body through urine. It is commonly used to treat diabetes and can also help protect the kidneys. In this trial, it is being tested to see how it affects protein levels in the urine of people with type 1 diabetes and kidney disease.

  • SC0062

    is an experimental medication that blocks endothelin receptors. Endothelin is a substance in the body that can narrow blood vessels and affect kidney function. By blocking these receptors, SC0062 may help protect the kidneys and reduce protein loss in the urine. In this trial, it is being tested both alone and in combination with dapagliflozin to see how it helps people with type 1 diabetes and kidney disease.

What is already known about the treatment

  • Dapagliflozin

    Dapagliflozin is a medication taken by mouth as a tablet that belongs to a class of drugs called SGLT2 inhibitors, which work by helping the kidneys remove excess sugar from the body through urine. It is an approved and widely used treatment for type 2 diabetes, heart failure, and chronic kidney disease, and is now being studied for use in people with type 1 diabetes who also have kidney problems. The drug works at the molecular level by blocking a specific protein in the kidney called sodium-glucose cotransporter 2, which normally reabsorbs sugar back into the blood, so blocking it allows more sugar to be eliminated from the body. In this clinical trial, researchers are testing whether dapagliflozin can help reduce protein loss in the urine when combined with another experimental medication called SC0062.

  • SC0062

    SC0062 is an investigational medication that is currently being studied in clinical trials and is not yet approved for general use in medical practice. This drug belongs to a class called endothelin receptor antagonists, which work by blocking the action of a natural substance in the body called endothelin that can cause blood vessels to narrow and contribute to kidney damage. At the molecular level, SC0062 prevents endothelin from binding to its receptors on cells, which helps relax blood vessels in the kidneys and may reduce the amount of protein leaking into the urine. In this trial, it is being tested both alone and in combination with dapagliflozin to see if it can help protect kidney function in people with type 1 diabetes and chronic kidney disease.

Investigated diseases

  • Chronic Kidney Disease

    Chronic kidney disease is a condition where the kidneys gradually lose their ability to filter waste products and excess fluids from the blood. This disease develops slowly over months or years, often without noticeable symptoms in the early stages. As the condition progresses, waste products build up in the body, leading to various health problems. The kidneys become less effective at maintaining the balance of minerals and fluids in the body. One common sign of kidney damage is the presence of protein, particularly albumin, in the urine. Without proper management, the kidney function continues to decline over time.

  • Type 1 Diabetes

    Type 1 diabetes is a chronic condition in which the pancreas produces little or no insulin, a hormone needed to allow sugar to enter cells for energy. This disease typically begins in childhood or adolescence, though it can develop at any age. The immune system mistakenly attacks and destroys the insulin-producing cells in the pancreas. Without insulin, sugar accumulates in the bloodstream instead of being used by cells. People with this condition require lifelong insulin replacement to survive. Over time, high blood sugar levels can damage various organs and blood vessels throughout the body.

Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-504404-28-00Protocol codeProtocol ID: 17042Estimated enrolment36 patientsSponsorUniversitair Medisch Centrum Groningen

sourced from the EU Clinical Trials Register and site verification

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