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Trial · NCT02383940

Results by group14

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

OutcomeGroupCategoryValueSpreadUnits
Change From Baseline in Hemoglobin A1C (A1C) at Week 12Placebo-0.99Standard Error 0.149percentage of A1C
Change From Baseline in Hemoglobin A1C (A1C) at Week 12Sotagliflozin 400 mg-1.33Standard Error 0.143percentage of A1C
Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12PlaceboTotal Daily Bolus Insulin Dose-2.96Standard Error 1.945International Units per day (IU/day)
Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12Sotagliflozin 400 mgTotal Daily Bolus Insulin Dose-4.89Standard Error 1.832International Units per day (IU/day)
Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12PlaceboTotal Daily Basal Insulin Dose3.26Standard Error 1.262International Units per day (IU/day)
Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12Sotagliflozin 400 mgTotal Daily Basal Insulin Dose2.03Standard Error 1.211International Units per day (IU/day)
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12Placebo0.2Standard Error 12.24milligrams per deciliter (mg/dL)
Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12Sotagliflozin 400 mg-56.4Standard Error 11.61milligrams per deciliter (mg/dL)
Change From Baseline in Glycemic Instability by Hyperglycemia (Continuous Glucose Monitoring [CGM] Area Under the Curve [AUC] >150 mg/dL) and Hypoglycemia (CGM AUC <70 mg/dL) Over a 24-hour Period at Week 12
PlaceboGlycemic Instability by Hyperglycemia-5.035Standard Error 7.9092mg/dL*minutes/1000
Change From Baseline in Glycemic Instability by Hyperglycemia (Continuous Glucose Monitoring [CGM] Area Under the Curve [AUC] >150 mg/dL) and Hypoglycemia (CGM AUC <70 mg/dL) Over a 24-hour Period at Week 12
Sotagliflozin 400 mgGlycemic Instability by Hyperglycemia-27.338Standard Error 8.0100mg/dL*minutes/1000
Change From Baseline in Glycemic Instability by Hyperglycemia (Continuous Glucose Monitoring [CGM] Area Under the Curve [AUC] >150 mg/dL) and Hypoglycemia (CGM AUC <70 mg/dL) Over a 24-hour Period at Week 12
PlaceboGlycemic Instability by Hypoglycemia0.221Standard Error 0.2508mg/dL*minutes/1000
Change From Baseline in Glycemic Instability by Hyperglycemia (Continuous Glucose Monitoring [CGM] Area Under the Curve [AUC] >150 mg/dL) and Hypoglycemia (CGM AUC <70 mg/dL) Over a 24-hour Period at Week 12
Sotagliflozin 400 mgGlycemic Instability by Hypoglycemia0.428Standard Error 0.2528mg/dL*minutes/1000
Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12Placebo-0.042Standard Error 0.0408events/day
Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12Sotagliflozin 400 mg-0.001Standard Error 0.0379events/day

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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