dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation (NCT06072326) | Clinical Trial Compass
Not Yet RecruitingPhase 2
dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation
Denmark, Finland36 participantsStarted 2026-01
Plain-language 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.
Who can participate
Age range18 Years – 65 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
* e…
What they're measuring
1
Change from baseline in Urine Albumin-Creatinine Ratio (UACR)