DAPAGLIFLOZIN for Type 1 diabetes mellitus | Chronic kidney disease

Inclusion criteria

• {"criterion_text":"- Willing and able to sign informed consent\n- Stable RAAS inhibition medication for at least 4 weeks prior to screening\n- HbA1c ≥6.5 and ≤10.5%\n- Based on the Investigator’s judgment participant must have a good understanding of his/her disease and how to manage it, and be willing and capable of performing the following study assessments (assessed before randomization): patient-led management and adjustment of insulin therapy; reliable approach to insulin dose adjustment for meals, such as carbohydrate counting; reliable and regular home-based blood glucose monitoring; established “sick day” management regimen\n- Male or female individuals diagnosed with type 1 diabetes at least 6 months prior to informed consent\n- Women of Childbearing Potential (WOCBP) must have a negative pregnancy test at screening and must not be lactating.\n- Male individuals must use highly effective method of contraception for the duration of the study (from the time they sign consent) and for 4 weeks after the last dose of study medication, or be able to provide proof of vasectomy.\n- Female individuals must use highly effective method of contraception for the duration of the study (from the time they sign consent) and for 4 weeks after the last dose of study medication, provide proof of hysterectomy or sterilization, or be deemed menopausal based on a FSH-test.\n- Age ≥18 and <65years, at the time of signing consent.\n- Body Mass Index ≥ 21 kg/m2\n- Urinary albumin:creatinine ratio ≥ 50 mg/g and <3000 mg/g\n- eGFR ≥ 30 and <90 ml/min/1.73m2"}

Exclusion criteria

• {"criterion_text":"- Diagnosis of type 2 diabetes, or other types of diabetes (e.g. LADA)\n- Any other clinical condition that, based on Investigator’s judgement, would jeopardize patient safety during trial participation or would affect the study outcome (e.g., immunocompromised patients, patients who might be at higher risk of developing urinary, genital or mycotic infections, patients with chronic viral infections, etc.)\n- Treatment with an SGLT2i within 30 days of Visit 1\n- NT-proBNP > 600 pg/mL\n- Strong CYP3A4 inducers or strong CYP3A4 inhibitors\n- Hemoglobin < 90 g/L\n- Diagnosis of severe edema (per investigator judgment) within 3 months of screening\n- Diagnosis of heart failure (NYHC stage III or IV)\n- Treatment with an anti-hyperglycaemic agent (e.g., metformin, alpha-glucosidase inhibitors, pramlintide, glucagon-like peptide receptor agonist, etc.) within 3 months\n- Occurrence of severe hypoglycaemia involving coma/unconsciousness and/or seizure that required hospitalisation or hypoglycaemia-related treatment by an emergency physician or paramedic within 3 months\n- Hypoglycaemia unawareness based on Investigator judgement or frequent episodes of unexplained hypoglycaemia (2 or more unexplained episodes within 3 months)\n- Occurrence of diabetic ketoacidosis within 6 months prior to study enrolment\n- Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack within 6 months"}

Primary endpoints

• {"endpoint_text":"- Change from baseline in Urine Albumin-Creatinine Ratio (UACR) when treated with SC0062 alone versus combination of dapagliflozin and SC0062.","definition_or_measurement_approach":"Change from baseline in Urine Albumin-Creatinine Ratio (UACR) (comparison of SC0062 alone versus combination of dapagliflozin and SC0062)."}

Secondary endpoints

• {"endpoint_text":"- Change from baseline in markers of fluid retention (body weight, hemoglobin, N-terminal prohormone of Brain Natriuretic Peptide (NT-proBNP)), Extracellular Volume (ECV), blood pressure, and estimated glomerular filtration rate (eGFR)when treated with SC0062 or dapagliflozin alone versus combination of dapagliflozin and SC0062. Safety: To assess the incidence, severity and seriousness of adverse events during treatment with SC0062 and/or dapagliflozin.","definition_or_measurement_approach":"Change from baseline in specified markers (body weight, hemoglobin, NT-proBNP, ECV, blood pressure, eGFR) and assessment of incidence/severity/seriousness of adverse events during treatment with SC0062 and/or dapagliflozin."}

Methods

• Site-based recruitment at participating hospital clinics (diabetes/endocrinology and nephrology clinics) in Denmark, Finland and the Netherlands (sites listed in Part II submissions).
• Printed recruitment materials / ASPIRE flyer (country-specific recruitment material documents present for DK, FI, NL).
• Country-specific recruitment arrangements documents (K1_Recruitment arrangements for DK, FI, NL) as submitted in Part II.

Denmark

Earliest CTIS Part Ii Submission Date

12-01-2026

Latest Decision Or Authorization Date

03-02-2026

Processing Time Days

22

Number Of Sites

3

Number Of Participants

15

Finland

Earliest CTIS Part Ii Submission Date

12-01-2026

Latest Decision Or Authorization Date

09-02-2026

Processing Time Days

28

Number Of Sites

2

Number Of Participants

10

Netherlands

Earliest CTIS Part Ii Submission Date

12-01-2026

Latest Decision Or Authorization Date

02-02-2026

Processing Time Days

21

Number Of Sites

2

Number Of Participants

11

Primary sponsor

Full Name

University Medical Center Groningen

Organisation Type

Hospital/Clinic/Other health care facility

Country Of Registered Address

Netherlands

Third parties

• {"country":"","full_name":"Juvenile Diabetes Research Foundation","duties_or_roles":"Monetary support / Funder","organisation_type":""}
• {"country":"","full_name":"Biocity Biopharmaceutics Co., Ltd.","duties_or_roles":"Monetary support / Funder","organisation_type":""}