| Outcome Measures: |
Primary: 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., Baseline to Week 12 | Secondary: 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., 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., 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., 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., 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., Baseline to Week 12
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| Locations: |
Lexicon Investigational Site, Concord, California, 94520, United States|Lexicon Investigational Site, Ventura, California, 93003, United States|Lexicon Investigational Site, Denver, Colorado, 80209, United States|Lexicon Investigational Site, Jacksonville, Florida, 32225, United States|Lexicon Investigational Site, Miami, Florida, 33175, United States|Lexicon Investigational Site, Springfield, Illinois, 62711, United States|Lexicon Investigational Site, Metairie, Louisiana, 70006, United States|Lexicon Investigational Site, Auburn, Maine, 04210, United States|Lexicon Investigational Site, Rockville, Maryland, 20852, United States|Lexicon Investigational Site, Great Falls, Montana, 59405, United States|Lexicon Investigational Site, Omaha, Nebraska, 68114, United States|Lexicon Investigational Site, High Point, North Carolina, 27265, United States|Lexicon Investigational Site, Columbus, Ohio, 43213, United States|Lexicon Investigational Site, San Antonio, Texas, 78229, United States|Lexicon Investigational Site, Salt Lake City, Utah, 84107, United States|Lexicon Investigational Site, Chesapeake, Virginia, 23321, United States|Lexicon Investigational Site, Manassas, Virginia, 20110, United States
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