Trial · NCT02926937
Outcomes14
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
1 to 14 of 14
Download this page as JSON| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 26 | Participants in the Intent-to-treat (ITT) population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| 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 | Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework. | millimole per liter (mmol/L) | LEAST_SQUARES_MEAN |
| 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 | Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework. | mmol/L | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 26 | Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1.Missing data are imputed using washout imputation method under the missing not at random framework. | mmol/L | LEAST_SQUARES_MEAN |
| 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 | Analysis was performed on participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1 with Baseline SBP ≥130 mmHg. Missing data are imputed using washout imputation method under the missing not at random framework. This Outcome Measure was pre-specified in the protocol to be assessed in the Placebo and Sotagliflozin 400 mg arms. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 12 | Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 200 mg Versus Placebo) | Baseline to Week 12 | Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework. | mmHg | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Baseline to Week 26 | Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework. | kilogram (Kg) | LEAST_SQUARES_MEAN |
| SECONDARY | Change From Baseline in Body Weight at Week 26 (Sotagliflozin 200 mg Versus Placebo) | Baseline to Week 26 | Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework. | kg | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Participants With HbA1c <6.5% at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Week 26 | Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. This Outcome Measure was pre-specified in the protocol to be assessed in the Placebo and Sotagliflozin 400 mg arms. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With HbA1c <7.0% at Week 26 (Sotagliflozin 400 mg Versus Placebo) | Week 26 | Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. This Outcome Measure was pre-specified in the protocol to be assessed in the Placebo and Sotagliflozin 400 mg arms. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in HbA1c at Week 26 (Sotagliflozin 200 mg Versus Placebo) | Baseline to Week 26 | Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1. Missing data are imputed using washout imputation method under the missing not at random framework. | percentage of HbA1c | LEAST_SQUARES_MEAN |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Hypoglycemic Events (Sotagliflozin 400 mg Versus Placebo) | Week 26 | Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. | percentage of participants | NUMBER |
| OTHER_PRE_SPECIFIED | Percentage of Participants With Hypoglycemic Events (Sotagliflozin 200 mg Versus Placebo) | Week 26 | Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1. | percentage of participants | NUMBER |
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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