Trial · NCT02926937
Registered outcomes14
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 26 | An analysis of covariance (ANCOVA) model was used for the analysis. |
| Secondary | Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 26 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 200 mg Versus Placebo) | Baseline to Week 26 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 26 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in Systolic Blood Pressure (SBP) at Week 12 in Participants With Baseline SBP ≥130 Millimeter of Mercury (mmHg) (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 12 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 12 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 200 mg Versus Placebo) | Baseline to Week 12 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in Body Weight at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 26 | An ANCOVA model was used for the analysis. |
| Secondary | Change From Baseline in Body Weight at Week 26 (Sotagliflozin 200 mg Versus Placebo) | Baseline to Week 26 | An ANCOVA model was used for the analysis. |
| Secondary | Percentage of Participants With HbA1c <6.5% at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Week 26 | |
| Secondary | Percentage of Participants With HbA1c <7.0% at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Week 26 | |
| Secondary | Change From Baseline in HbA1c at Week 26 (Sotagliflozin 200 mg Versus Placebo) | Baseline to Week 26 | An ANCOVA model was used for the analysis. |
| Other | Percentage of Participants With Hypoglycemic Events (Sotagliflozin 400 mg Versus Placebo) | Week 26 | Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤70 mg/dL (3.9 mmol/L)\]; Severe \[an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions\] or documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia and plasma glucose ≤70 mg/dL\]. Participants may be reported in more than one category. |
| Other | Percentage of Participants With Hypoglycemic Events (Sotagliflozin 200 mg Versus Placebo) | Week 26 | Percentage of participants with hypoglycemic events are reported for the following 3 categories: Any hypoglycemia (as reported in the Electronic Case Report Form); Documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia (increased sweating, nervousness, asthenia/weakness, tremor, dizziness, increased appetite, palpitations, headache, sleep disorder, confusion, seizures, unconsciousness, and/or coma) and plasma glucose ≤70 mg/dL (3.9 mmol/L)\]; Severe \[an event requiring assistance of another person to actively administer carbohydrate, glucagon, intravenous glucose or other resuscitative actions\] or documented symptomatic hypoglycemia \[typical symptoms of hypoglycemia and plasma glucose ≤70 mg/dL\]. Participants may be reported in more than one category. |
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.
For software
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