dApagliflozin SC0062 and Prevention of Renal Injury; a Randomized Evaluation

Study acronym: ASPIRE-1
StatusNot Yet Recruiting
PhasePhase 2
Started

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Trial flagged as At Risk
Primary completion moved at least 12 months later Dec 2027 → Jan 2029
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Record History

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  1. Primary completion pushed from Dec 2027 to Jan 2029 Show 6 more changesShow less
    • Start date: Jan 2026 to Jan 2027
    • Study completion pushed from Dec 2028 to Jan 2030
    • Study sites: 7 to 5
    • Eligibility criteria expanded, about 36 words
    • Secondary endpoints revised (7)
    • Study description shortened, about 9 words
  2. Start date: Sep 2025 to Jan 2026v4 Show 10 more changesShow less
    • Primary completion date: Sep 2027 to Dec 2027
    • Study completion date: Dec 2027 to Dec 2028
    • Interventions: Ambrisentan (Drug), Ambrisentan and Sotagliflozin (Drug), Sotagliflozin (Drug) to Dapagliflozin (Forxiga®) (Drug), SC0062 and dapagliflozin (Drug), SC0062 strength 10mg (Drug)
    • Eligibility criteria expanded, about 19 words
    • Secondary endpoints revised (7)
    • Primary endpoint revised
    • Study sites revised (7)
    • Collaborators revised (2)
    • Study title revised
    • Study description expanded, about 2 words
  3. Primary completion date: Mar 2025 to Sep 2027
    • Start date: Mar 2024 to Sep 2025
    • Study completion date: Mar 2025 to Dec 2027
    • Site details revised at 1 of 7 sites
    v3
  4. Secondary endpoints: 4 to 7v2
  5. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06072326
Lead Sponsor University Medical Center Groningen
Collaborators: Juvenile Diabetes Research Foundation, Biocity Biopharmaceutics Co., Ltd.
Conditions
(from sponsor)		 Type 1 Diabetes Mellitus With Diabetic Nephropathy
Related terms Diabetes Mellitus, Type 1, Diabetic Nephropathies
Enrollment 36 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov