| Primary | Change From Baseline in Hemoglobin A1c (HbA1c) at Week 26 (Sotagliflozin 400 mg Versus Placebo) | An analysis of covariance (ANCOVA) model was used for the analysis. | 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. | Posted | | Least Squares Mean | Standard Error | percentage of HbA1c | | Baseline to Week 26 | | | | ID | Title | Description |
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| OG000 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. | | OG001 | Sotagliflozin 400 mg | Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
| | | Title | Denominators | Categories |
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| | | Title | Measurements |
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| - OG000-0.34± 0.120
- OG001-1.03± 0.122
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| The change from baseline to Week 26 is analyzed using ANCOVA model with treatment groups, randomization strata of HbA1c (≤8.0, >8.0%) at screening, randomization strata of mean SBP (<130, ≥130 mmHg) at screening, and country as fixed effects, and baseline HbA1c as a covariate. | ANCOVA | | <0.0001 | | Difference in Least Squares (LS) Mean | -0.69 | | | 2-Sided | 95 | -0.975 | -0.415 | | | | | Superiority | | |
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| Secondary | Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 400 mg Versus Placebo) | An ANCOVA model was used for the analysis. | 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. | Posted | | Least Squares Mean | Standard Error | millimole per liter (mmol/L) | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. | | OG001 | Sotagliflozin 400 mg | Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
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| Secondary | Change From Baseline in 2-hour Postprandial Plasma Glucose (PPG) Following a Mixed Meal at Week 26 (Sotagliflozin 200 mg Versus Placebo) | An ANCOVA model was used for the analysis. | 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. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. | | OG001 | Sotagliflozin 200 mg | Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks |
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| Secondary | Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 (Sotagliflozin 400 mg Versus Placebo) | An ANCOVA model was used for the analysis. | 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. | Posted | | Least Squares Mean | Standard Error | mmol/L | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. | | OG001 | Sotagliflozin 400 mg | Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
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| 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) | An ANCOVA model was used for the analysis. | 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. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. | | OG001 | Sotagliflozin 400 mg | Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
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| Secondary | Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 400 mg Versus Placebo) | An ANCOVA model was used for the analysis. | 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. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. | | OG001 | Sotagliflozin 400 mg | Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
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| Secondary | Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 200 mg Versus Placebo) | An ANCOVA model was used for the analysis. | 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. | Posted | | Least Squares Mean | Standard Error | mmHg | | Baseline to Week 12 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. | | OG001 | Sotagliflozin 200 mg | Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
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| Secondary | Change From Baseline in Body Weight at Week 26 (Sotagliflozin 400 mg Versus Placebo) | An ANCOVA model was used for the analysis. | 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. | Posted | | Least Squares Mean | Standard Error | kilogram (Kg) | | Baseline to Week 26 | | | | ID | Title | Description |
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| OG000 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. | | OG001 | Sotagliflozin 400 mg | Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
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| Secondary | Change From Baseline in Body Weight at Week 26 (Sotagliflozin 200 mg Versus Placebo) | An ANCOVA model was used for the analysis. | 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. | Posted | | Least Squares Mean | Standard Error | kg | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. | | OG001 | Sotagliflozin 200 mg | Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
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| Secondary | Percentage of Participants With HbA1c <6.5% at Week 26 (Sotagliflozin 400 mg Versus Placebo) | | 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. | Posted | | Number | | percentage of participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. | | OG001 | Sotagliflozin 400 mg | Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
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| Secondary | Percentage of Participants With HbA1c <7.0% at Week 26 (Sotagliflozin 400 mg Versus Placebo) | | 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. | Posted | | Number | | percentage of participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. | | OG001 | Sotagliflozin 400 mg | Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
| |
| Secondary | Change From Baseline in HbA1c at Week 26 (Sotagliflozin 200 mg Versus Placebo) | An ANCOVA model was used for the analysis. | 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. | Posted | | Least Squares Mean | Standard Error | percentage of HbA1c | | Baseline to Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. | | OG001 | Sotagliflozin 200 mg | Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
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| Other Pre-specified | Percentage of Participants With Hypoglycemic Events (Sotagliflozin 400 mg Versus Placebo) | 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. | Participants in the ITT population who were randomized to Sotagliflozin 400 mg and Placebo under original Protocol and Protocol Amendment 1. | Posted | | Number | | percentage of participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. | | OG001 | Sotagliflozin 400 mg | Following a 2-week run-in period, participants were randomized to Sotagliflozin 400 mg administered as two 200 mg tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
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| Other Pre-specified | Percentage of Participants With Hypoglycemic Events (Sotagliflozin 200 mg Versus Placebo) | 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. | Participants in the ITT population who were randomized to Sotagliflozin 200 mg and Placebo under Protocol Amendment 1. | Posted | | Number | | percentage of participants | | Week 26 | | | | ID | Title | Description |
|---|
| OG000 | Placebo | Following a 2-week run-in period, participants were randomized to matching placebo to sotagliflozin administered as 2 tablets, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. | | OG001 | Sotagliflozin 200 mg | Following a 2-week run-in period, participants were randomized to Sotagliflozin 200 mg administered as 1 sotagliflozin tablet and 1 matching placebo tablet, QD, before the first meal of the day in the double-blind treatment period for up to 26 weeks. |
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