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Clinical Trials in Denmark / NCT06072326
Starting soon Phase 2

dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation

NCT06072326 · tracked via the Priya Life Science Denmark tracker
Phase
Phase 2
Started
2026-01
Last updated
2025-10-07

Condition(s) studied

Type 1 Diabetes Mellitus With Diabetic Nephropathy

Investigational drug(s) / intervention(s)

Dapagliflozin (Forxiga®) →SC0062 strength 10mg →SC0062 and dapagliflozin

Dapagliflozin (Forxiga®): 5 mg/day as a tablet

SC0062 strength 10mg: 20 mg/day, twice daily, capsule

SC0062 and dapagliflozin: 20 mg/day SC0062 10 mg twice daily as a capsule in combination with 5 mg/day dapagliflozin 5 mg as a tablet

Study summary

The aim of this study is to test the hypothesis that dapagliflozin (SGLT2 inhibitor) and SC0062 (ERA) combination therapy augments nephroprotection and mitigates fluid retention and ketogenesis in people with T1D through complementary and synergistic mechanisms of actions.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Willing and able to sign informed consent * Male or female individuals diagnosed with type 1 diabetes at least 6 months prior to informed consent * WOCBP must have a negative pregnancy test at screening and must not be lactating. * 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. * 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. * Age ≥18 and \<65years, at the time of signing consent. * Body Mass Index ≥ 21 kg/m2 * Urinary albumin:creatinine ratio ≥ 50 mg/g and \<3000 mg/g * eGFR ≥30 and \<90 ml/min/1.73m2 * Stable RAAS inhibition medication for at least 4 weeks prior to screening * HbA1c ≥6.5 and \<10.5%. * 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 Exclusion Criteria: * Diagnosis of type 2 diabetes, or other types of diabetes (e.g. LADA). * Treatment with an anti-hyperglycaemic agent (e.g., metformin, alpha-glucosidase inhibitors, pramlintide, glucagon-like peptide receptor agonist, etc.) within 3 months. * 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. * Hypoglycaemia unawareness based on Investigator judgement or frequent episodes of unexplained hypoglycaemia (2 or more unexplained episodes within 3 months). * Occurrence of diabetic ketoacidosis within 6 months prior to study enrolment. * Acute coronary syndrome (non-STEMI, STEMI and unstable angina pectoris), stroke or transient ischemic attack within 6 months. * 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.). * Treatment with an SGLT2i within 30 days of Visit 1. * NT-proBNP \> 600 pg/mL * Hemoglobin \< 90 g/L * Diagnosis of severe edema (per investigator judgment) within 3 months of screening * Diagnosis of heart failure (NYHC stage III or IV).

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
Steno Diabetes Center Aarhus Aarhus Denmark
Steno Diabetes Center Copenhagen Copenhagen Denmark
Regionshospitalet Gødstrup Herning Denmark
University of Helsinki Helsinki Uusimaa
Turku University Hospital Turku Finland
Amsterdam University Academic Center Amsterdam North Holland
University Medical Center Groningen Groningen Provincie Groningen

More University Medical Center Groningen trials in Denmark

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06072326 on ClinicalTrials.gov ↗ ← All trials in Denmark