| Outcome Measures: |
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., Baseline to Week 26 | 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., Baseline to Week 26|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., Baseline to Week 26|Change From Baseline in Fasting Plasma Glucose (FPG) at Week 26 (Sotagliflozin 400 mg Versus Placebo), An ANCOVA model was used for the analysis., Baseline to Week 26|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., Baseline to Week 12|Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 400 mg Versus Placebo), An ANCOVA model was used for the analysis., Baseline to Week 12|Change From Baseline in SBP at Week 12 for All Participants (Sotagliflozin 200 mg Versus Placebo), An ANCOVA model was used for the analysis., Baseline to Week 12|Change From Baseline in Body Weight at Week 26 (Sotagliflozin 400 mg Versus Placebo), An ANCOVA model was used for the analysis., Baseline to Week 26|Change From Baseline in Body Weight at Week 26 (Sotagliflozin 200 mg Versus Placebo), An ANCOVA model was used for the analysis., Baseline to Week 26|Percentage of Participants With HbA1c <6.5% at Week 26 (Sotagliflozin 400 mg Versus Placebo), Week 26|Percentage of Participants With HbA1c <7.0% at Week 26 (Sotagliflozin 400 mg Versus Placebo), Week 26|Change From Baseline in HbA1c at Week 26 (Sotagliflozin 200 mg Versus Placebo), An ANCOVA model was used for the analysis., Baseline to Week 26 | Other: 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., Week 26|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., Week 26
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| Locations: |
Investigational Site Number 8401049, Tucson, Arizona, 85741, United States|Investigational Site Number 8401026, Tucson, Arizona, 85745, United States|Investigational Site Number 8401028, Anaheim, California, 92801, United States|Investigational Site Number 8401057, Canoga Park, California, 91303, United States|Investigational Site Number 8401058, Garden Grove, California, 92844-2751, United States|Investigational Site Number 8401029, Hawaiian Gardens, California, 90716, United States|Investigational Site Number 8401017, Huntington Park, California, 90255, United States|Investigational Site Number 8401056, Long Beach, California, 90806, United States|Investigational Site Number 8401013, Long Beach, California, 90807, United States|Investigational Site Number 8401063, Los Angeles, California, 90036, United States|Investigational Site Number 8401011, Los Angeles, California, 90057, United States|Investigational Site Number 8401022, Montclair, California, 91763, United States|Investigational Site Number 8401039, Norwalk, California, 90650, United States|Investigational Site Number 8401035, San Dimas, California, 91713, United States|Investigational Site Number 8401025, Tustin, California, 92780, United States|Investigational Site Number 8401015, Van Nuys, California, 91405, United States|Investigational Site Number 8401031, Denver, Colorado, 80220, United States|Investigational Site Number 8401060, Northglenn, Colorado, 80234, United States|Investigational Site Number 8401024, Bradenton, Florida, 34201, United States|Investigational Site Number 8401040, Clearwater, Florida, 33756, United States|Investigational Site Number 8401014, Daytona Beach, Florida, 32117, United States|Investigational Site Number 8401007, Hialeah, Florida, 33012, United States|Investigational Site Number 8401046, Homestead, Florida, 33030, United States|Investigational Site Number 8401018, Miami, Florida, 33135, United States|Investigational Site Number 8401008, Miami, Florida, 33185, United States|Investigational Site Number 8401053, Orlando, Florida, 32825, United States|Investigational Site Number 8401062, Palm Harbor, Florida, 34684, United States|Investigational Site Number 8401061, West Palm Beach, Florida, 33406-5854, United States|Investigational Site Number 8401033, Atlanta, Georgia, 30303, United States|Investigational Site Number 8401044, Chicago, Illinois, 60602, United States|Investigational Site Number 8401052, Newton, Iowa, 50208, United States|Investigational Site Number 8401016, West Des Moines, Iowa, 50265, United States|Investigational Site Number 8401034, Wichita, Kansas, 67205-1138, United States|Investigational Site Number 8401038, Lake Charles, Louisiana, 70601, United States|Investigational Site Number 8401042, Fayetteville, North Carolina, 28314, United States|Investigational Site Number 8401012, Greensboro, North Carolina, 27401, United States|Investigational Site Number 8401048, Akron, Ohio, 44311, United States|Investigational Site Number 8401003, Marion, Ohio, 43302, United States|Investigational Site Number 8401020, Corvallis, Oregon, 97330, United States|Investigational Site Number 8401006, Eugene, Oregon, 97404, United States|Investigational Site Number 8401041, Levittown, Pennsylvania, 19056, United States|Investigational Site Number 8401051, Anderson, South Carolina, 29621, United States|Investigational Site Number 8401002, Greer, South Carolina, 29651, United States|Investigational Site Number 8401005, Fort Worth, Texas, 76164, United States|Investigational Site Number 8401019, Houston, Texas, 77081, United States|Investigational Site Number 8401050, Houston, Texas, 77099, United States|Investigational Site Number 8401037, Katy, Texas, 77450, United States|Investigational Site Number 8401043, McAllen, Texas, 78504, United States|Investigational Site Number 8401059, North Richland Hills, Texas, 76180, United States|Investigational Site Number 8401004, San Antonio, Texas, 78218, United States|Investigational Site Number 8401054, San Antonio, Texas, 78229, United States|Investigational Site Number 8401001, San Antonio, Texas, 78231, United States|Investigational Site Number 8401055, Schertz, Texas, 78154, United States|Investigational Site Number 8401023, Sugar Land, Texas, 77478, United States|Investigational Site Number 8401032, Chesapeake, Virginia, 23321-5205, United States|Investigational Site Number 8401010, Suffolk, Virginia, 23435-3763, United States|Investigational Site Number 1241002, Sherbrooke, J1L 0H8, Canada|Investigational Site Number 1241005, Toronto, M3M 3E5, Canada|Investigational Site Number 1241001, Toronto, M9W 4L6, Canada|Investigational Site Number 1241006, Vancouver, V5X 0C4, Canada|Investigational Site Number 4841006, Aguascalientes, 20230, Mexico|Investigational Site Number 4841010, Aguascalientes, 20230, Mexico|Investigational Site Number 4841003, Cd. México, México, 11410, Mexico|Investigational Site Number 4841004, Chihuahua, 31200, Mexico|Investigational Site Number 4841001, Culiacan, 80230, Mexico|Investigational Site Number 4841005, Durango, Durango, 34080, Mexico|Investigational Site Number 4841009, Guadalajara, 44600, Mexico|Investigational Site Number 4841007, Mexico, 11850, Mexico|Investigational Site Number 4841002, Monterrey, Nuevo León, 64460, Mexico|Investigational Site Number 4841008, Monterrey, 64020, Mexico
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