The primary objective of this study was to define the dose leading to desirable efficacy, as measured by the change in hemoglobin A1C (A1C) between Baseline and Week 12.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
141
Placebo, once daily, before the first meal of the day
Sotagliflozin,once daily, before the first meal of the day
Lexicon Investigational Site
Concord, California, United States
Lexicon Investigational Site
Ventura, California, United States
Change From Baseline in Hemoglobin A1C (A1C) at Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-baseline Least Square (LS) mean values were obtained from mixed-effects model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery method (continuous subcutaneous insulin infusion \[CSII\] or multiple daily injection \[MDI\]), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate.
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in 2-Hour Postprandial Glucose (PPG) Following the Standardized Mixed Meal
A 2-hour PPG sample (plasma) was obtained 2-hours after a standardized Mixed Meal at Baseline (Day 1) and at the visit at Week 12. Post-Baseline LS mean was obtained from analysis of covariance (ANCOVA) model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and baseline postprandial glucose as a covariate.
Time frame: Baseline, Week 12
Absolute Change From Baseline in Body Weight to Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate.
Time frame: Baseline to Week 12
Percent Change From Baseline in Body Weight to Week 12
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline weight-by-time interaction as a covariate.
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Lexicon Investigational Site
Denver, Colorado, United States
Lexicon Investigational Site
Jacksonville, Florida, United States
Lexicon Investigational Site
Miami, Florida, United States
Lexicon Investigational Site
Springfield, Illinois, United States
Lexicon Investigational Site
Metairie, Louisiana, United States
Lexicon Investigational Site
Auburn, Maine, United States
Lexicon Investigational Site
Rockville, Maryland, United States
Lexicon Investigational Site
Great Falls, Montana, United States
...and 7 more locations
Time frame: Baseline to Week 12
Change From Baseline to Week 12 in 24-Hour Urinary Glucose Excretion
Urine was collected over 24 hours to measure Urinary Glucose Excretion at baseline, and at the end of the 12-week treatment. Post-Baseline LS mean was obtained from ANCOVA model with treatment, randomization strata of insulin delivery method (CSII, MDI) as fixed categorical effects, and Baseline urinary glucose excretion as a covariate.
Time frame: Baseline, Week 12
Change From Baseline to Week 12 in Fasting Plasma Glucose
Baseline was defined as the last value collected prior to the first dose of double-blind study medication. Post-Baseline LS mean was obtained from MMRM model with treatment, randomization strata of insulin delivery method (CSII, MDI), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline fasting plasma glucose-by-time interaction as a covariate.
Time frame: Baseline to Week 12