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Trial · NCT06217302

Registered outcomes25

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
OtherMean GRI during the treatment periodWeeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)Mean glycemic risk index (GRI) from continuous glucose monitoring during the 3-year treatment period
OtherMean total daily insulin dose during the treatment periodWeeks 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)Mean total daily insulin dose (TDD, units/kg) during the 3-year treatment period
OtherUrinary albumin excretion rate change from baseline equal to or more negative than -30% at the end of treatmentEnd of treatment period (Week 156).Urinary albumin excretion rate (UAER, timed overnight collection) reduction from baseline ≥30% at the end of treatment;
OtherUrinary albumin excretion rate change from baseline equal to or more negative than -30% at the end of the washout periodEnd of the 2-month wash-out period following the 3-year treatment period (week 164)Urinary albumin excretion rate (UAER) reduction from baseline ≥30% at the end of the 8-week washout period following the 3-year treatment period;
OthereGFR slope during the treatment periodWeeks 0, 2, 8, 16, 28, 44, 60, 76, 92, 108, 124, 140 156 (from baseline to the end of the treatment period)eGFR slope from baseline to the end of the 3-yr treatment period (before the washout period), kidney failure, death, or study discontinuation, whichever occurs first

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

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