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Trial · NCT03066830

Results by group20

Each measurement the trial posted, group by group, in the words and numbers it posted.

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26Placebo0.06Standard Error 0.082percentage HbA1c
Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26Sotagliflozin 400 mg-0.70Standard Error 0.068percentage HbA1c
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26Placebo0.277Standard Error 0.2691millimole per liter (mmol/L)
Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26Sotagliflozin 400 mg-1.331Standard Error 0.1844millimole per liter (mmol/L)
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHgPlacebo-3.58Standard Error 1.052mmHg
Change From Baseline in Systolic Blood Pressure (SBP) for Participants With Baseline SBP ≥130 mmHgSotagliflozin 400 mg-4.41Standard Error 1.061mmHg
Change From Baseline in SBP at Week 12 for All ParticipantsPlacebo-0.69Standard Deviation 0.826mmHg
Change From Baseline in SBP at Week 12 for All ParticipantsSotagliflozin 400 mg-1.71Standard Deviation 0.830mmHg
Change From Baseline in Body Weight at Week 26Placebo-0.29Standard Deviation 0.206kilogram (kg)
Change From Baseline in Body Weight at Week 26Sotagliflozin 400 mg-1.70Standard Deviation 0.215kilogram (kg)
Percentage of Participants With HbA1c <6.5% at Week 26Placebo1.6percentage of participants
Percentage of Participants With HbA1c <6.5% at Week 26Sotagliflozin 400 mg8.3percentage of participants
Percentage of Participants With HbA1c <7.0% at Week 26Placebo8.7percentage of participants
Percentage of Participants With HbA1c <7.0% at Week 26Sotagliflozin 400 mg26.1percentage of participants
Percentage of Participants With Hypoglycemic EventsPlaceboAny hypoglycemia22.1percentage of participants
Percentage of Participants With Hypoglycemic EventsSotagliflozin 400 mgAny hypoglycemia19.7percentage of participants
Percentage of Participants With Hypoglycemic EventsPlaceboDocumented symptomatic hypoglycemia13.0percentage of participants
Percentage of Participants With Hypoglycemic EventsSotagliflozin 400 mgDocumented symptomatic hypoglycemia11.4percentage of participants
Percentage of Participants With Hypoglycemic EventsPlaceboSevere or documented symptomatic hypoglycemia13.0percentage of participants
Percentage of Participants With Hypoglycemic EventsSotagliflozin 400 mgSevere or documented symptomatic hypoglycemia11.8percentage of participants

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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