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Dapagliflozin and SC0062 in adults with type 1 diabetes and chronic kidney disease: effect on albuminuria in a Phase 2 randomized trial

Verified siteRegistered drugNo placebo
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What is this trial about?

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

Adults who have both Chronic Kidney Disease and Type 1 Diabetes are being studied. The trial uses an already approved oral medicine called dapagliflozin, which helps the kidneys remove extra sugar, together with an experimental capsule known as SC0062. Both drugs are taken by mouth.

The purpose of the study is to determine whether the combination of these two medicines lowers the amount of protein that leaks into the urine, a condition called albuminuria, which is measured by the Urine Albumin-Creatinine Ratio. Participants will receive one treatment period with SC0062 alone and another period with both dapagliflozin and SC0062, with regular clinic visits for urine and blood tests, weight checks, and blood‑pressure measurements. The urine test looks at how much albumin (a type of protein) is present relative to creatinine, a waste product, to assess kidney leakage, while overall kidney function is also evaluated using the estimated glomerular filtration rate, a calculation that estimates how well the kidneys filter blood.

Throughout the study, safety is closely watched by recording any unwanted effects, checking blood work, and observing changes in body weight and fluid balance. The trial lasts several months, with each treatment phase followed by a short break before the next phase begins.

The research process

The trial runs in 8 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Baseline Visit

    You will attend a first visit after joining the study where a series of measurements will be taken.

    These measurements include blood tests, urine tests, body weight, blood pressure, and a kidney function estimate called eGFR.

    The purpose of these assessments is to establish your starting values for comparison during the trial.

  2. Step 2

    Randomization to Treatment Sequence

    Based on the information collected at the baseline visit, you will be randomly assigned to one of two treatment sequences.

    One sequence starts with the study drug SC0062 alone, and the other starts with a combination of SC0062 and dapagliflozin.

  3. Step 3

    First Treatment Period

    During the first period you will take the assigned medication(s) every day by mouth.

    The study drug SC0062 is provided as a hard capsule containing 20 mg and is taken once daily.

    If your sequence includes the combination, you will also take a film‑coated tablet of dapagliflozin containing 5 mg once daily.

    You will continue taking the medication(s) for the entire length of the first period as defined by the study protocol.

  4. Step 4

    Monitoring Visits During First Period

    At scheduled intervals you will return to the clinic for safety checks and to collect urine and blood samples.

    These visits allow the study team to monitor your kidney function, body weight, blood pressure, and any side effects.

    You will be asked to report any new symptoms or concerns at each visit.

  5. Step 5

    Washout Period

    After the first treatment period you will have a short washout period during which you stop taking the study medication(s).

    The washout period helps to clear the drugs from your system before starting the next treatment sequence.

  6. Step 6

    Second Treatment Period

    You will begin the second treatment period, receiving the medication(s) that were not given during the first period.

    If you previously received SC0062 alone, you will now take both SC0062 (20 mg capsule) and dapagliflozin (5 mg tablet) once daily.

    If you previously received the combination, you will now take only SC0062 20 mg capsule once daily.

    You will continue the assigned medication(s) for the full length of the second period as specified in the protocol.

  7. Step 7

    Monitoring Visits During Second Period

    Similar to the first period, you will attend regular clinic visits for safety assessments and laboratory tests.

    These visits will again measure urine albumin‑creatinine ratio (UACR), body weight, blood pressure, and other kidney‑related markers.

  8. Step 8

    Final Assessment and End of Trial

    At the conclusion of the second treatment period you will undergo a final set of tests identical to those performed at baseline.

    The results will be used to compare how the kidney measurements changed with each treatment.

    After the final assessment the study participation ends for you.

Who can join the trial?

15 criteria

  • Be willing and able to sign a informed consent form, which means you agree to take part after understanding what the study involves.
  • Take a stable dose of RAAS inhibition medication (drugs that help protect the kidneys) for at least 4 weeks before the screening visit.
  • Have a blood test result called HbA1c that is between 6.5% and 10.5%; this test shows your average blood sugar level over the past few months.
  • Understand your type 1 diabetes and be able to manage it, including:
    • Adjusting your insulin yourself.
    • Counting carbohydrates in meals (carbohydrate counting) to decide insulin doses.
    • Checking your blood sugar at home regularly (blood glucose monitoring).
    • Having a plan for “sick days” when illness may change your insulin needs.
    • Have been diagnosed with type 1 diabetes for at least 6 months before signing the consent.
    • If you are a woman who could become pregnant (Women of Childbearing Potential), you must have a negative pregnancy test at screening and must not be breastfeeding.
    • If you are a man, you must use a highly effective form of contraception during the study and for 4 weeks after the last dose, or provide proof of a vasectomy (surgical procedure that prevents sperm release).
    • If you are a woman, you must use a highly effective form of contraception during the study and for 4 weeks after the last dose, or provide proof of a hysterectomy (removal of the uterus), sterilization, or be confirmed as menopausal (no periods) with an FSH test (a blood test that checks hormone levels).
    • Be at least 18 years old but younger than 65 years at the time you sign the consent.
    • Have a Body Mass Index (BMI) of 21 kg/m² or higher; BMI is a measure of body weight relative to height.
    • Have a urine test showing an urinary albumin-to-creatinine ratio of 50 to less than 3000 mg/g; this measures how much protein is leaking from the kidneys.
    • Have an estimated kidney function called eGFR between 30 and less than 90 mL/min/1.73 m²; this tells how well your kidneys are filtering waste.

Who cannot join the trial?

13 criteria

  • Having type 2 diabetes or other forms of diabetes such as LADA (a type of autoimmune diabetes that can look like type 2).
  • Having a low level of hemoglobin (the protein in blood that carries oxygen) less than 90 g/L.
  • Having severe edema (significant swelling) judged by the doctor within the past 3 months.
  • Having heart failure classified as NYHA stage III or IV (moderate to severe difficulty with daily activities because of heart problems).
  • Taking medicines that strongly increase or decrease the activity of the liver enzyme CYP3A4 (these can change how other drugs work).
  • Using any anti‑hyperglycaemic agent (blood‑sugar‑lowering medicine such as metformin, alpha‑glucosidase inhibitors, pramlintide, GLP‑1 receptor agonists, etc.) within the past 3 months.
  • Having a episode of severe hypoglycaemia that caused loss of consciousness, a seizure, required a hospital stay, or needed emergency treatment in the past 3 months.
  • Having hypoglycaemia unawareness (not feeling the warning signs of low blood sugar) or two or more unexplained low‑blood‑sugar episodes in the past 3 months.
  • Having had diabetic ketoacidosis (a serious condition where the body builds up too many acids) within the past 6 months.
  • Having an acute coronary syndrome event (such as a heart attack or unstable chest pain), a stroke, or a transient ischemic attack (a brief stroke‑like episode) within the past 6 months.
  • Having any other health problem that the doctor thinks would make the study unsafe or affect the results (for example, being immunocompromised, having a higher risk of urinary, genital or mycotic infections, or having chronic viral infections).
  • Using an SGLT2i (a specific type of diabetes medicine) within 30 days before the first study visit.
  • Having a blood test result of NT‑proBNP greater than 600 pg/mL (a marker that can indicate strain on the heart).
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Investigated drugs

  • SC0062

    is an experimental oral capsule being studied for its potential to protect the kidneys in people with type 1 diabetes. In this trial, participants take SC0062 by mouth, and researchers are looking to see if it can reduce the amount of protein (albumin) that leaks into the urine, which is a sign of kidney damage.

  • Dapagliflozin

    (brand name Forxiga) is a pill taken by mouth that belongs to a class of medicines called SGLT2 inhibitors. It works by helping the kidneys remove extra sugar from the body through the urine, which can lower blood sugar levels. In this study, dapagliflozin is being tested both alone and together with SC0062 to see if it can further reduce urinary albumin and improve kidney health in adults with type 1 diabetes.

What is already known about the treatment

  • N-[5-(2H-1,3-BENZODIOXOL-5-YL)-6-{2-[(5-BROMOPYRIMIDIN-2-YL)OXY]ETHOXY}PYRIMIDIN-4-YL]-N'-(2-METHOXYETHYL)SULFURIC DIAMIDE

    It is taken as a hard capsule containing 20 mg, swallowed by mouth. This substance is still experimental and appears only in early‑phase clinical studies, so it is not yet approved for any medical use. The trial is testing it for kidney damage in adults with type 1 diabetes, hoping it will lower the amount of protein that leaks into urine. It works by blocking endothelin receptors, which helps relax kidney blood vessels and reduce inflammation, and it belongs to the class of endothelin receptor antagonists.

  • Dapagliflozin

    It is taken as a 5 mg film‑coated tablet taken orally. Dapagliflozin is an approved drug that has been studied extensively in many clinical trials and is listed in medical guidelines. It is used to lower blood sugar in diabetes and to protect kidney function, and it works by blocking the SGLT2 protein in the kidney so that excess glucose is excreted in the urine. Pharmacologically it belongs to the class of sodium‑glucose co‑transporter‑2 (SGLT2) inhibitors.

Investigated diseases

  • Chronic kidney disease

    Chronic kidney disease is a long‑term condition in which the kidneys gradually lose their ability to filter waste and excess fluid from the blood. The loss of function progresses from mild impairment to more severe reduction, often measured by a decreasing glomerular filtration rate. As kidney function declines, waste products and fluid can accumulate, leading to changes in urine output and swelling.

  • Type 1 diabetes

    Type 1 diabetes is an autoimmune disease in which the immune system destroys the insulin‑producing cells of the pancreas. Without insulin, blood sugar levels rise and remain high unless they are manually lowered. The condition typically begins in childhood or early adulthood and can persist for a lifetime, with high blood sugar gradually affecting various organs.

Trial detailsLast updated 13 Oct 2026
Age18+ yearsPhasePhase IITrial ID2026-525684-40-01Estimated enrolment30 patientsSponsorUniversitair Medisch Centrum Groningen

sourced from the EU Clinical Trials Register and site verification

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