dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation

Sex: All

Ages: 18 Years – 64 Years

Healthy volunteers: No

Phase: PHASE2

Enrollment: 36

Sponsor: University Medical Center Groningen

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 Criteria

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 \

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06072326). StuddyBuddy aggregates publicly available trial information.