| 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. Change was calculated by subtracting baseline value from Week 12 value. Least Square (LS) mean changes from baseline were obtained from mixed model repeated measures (MMRM) model with treatment, randomization strata of insulin delivery (MDI, CSII) and Week-4 A1C (\<=10%, \>10%), time (study week), and a treatment-by-time interaction as fixed categorical effects, and baseline A1C-by-time interaction as a covariate., Baseline, Week 12 | Secondary: Change From Baseline in Total Daily Bolus Insulin Dose and Total Daily Basal Insulin Dose at Week 12, The daily bolus and basal insulin doses were calculated as an average of the doses over 3 to 5 days before each visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model., Baseline, Week 12|Change From Baseline in 2-hour Postprandial Glucose (PPG) Following a Standardized Mixed Meal at Week 12, 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. At Week 12, study drug was to be given within 15 minutes before liquid "Boost®," "Ensure®," or similar nutrition drink product; at baseline, study drug was to be given after the 2-hour post-Mixed Meal PPG sample. Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from analysis of covariance (ANCOVA) model., Baseline, Week 12|Change From Baseline in Glycemic Instability by Hyperglycemia (Continuous Glucose Monitoring [CGM] Area Under the Curve [AUC] >150 mg/dL) and Hypoglycemia (CGM AUC <70 mg/dL) Over a 24-hour Period at Week 12, Glycemic instability (mg/dL\*minutes/1000) by hyperglycemia/hypoglycemia was measured by CGM AUC outside target range (as a daily average over the week prior to the visit \[Baseline and Week 12\]) over 24 hours, where outside target range was defined as CGM glucose AUC \>150 mg/dL (hyperglycemia) and CGM glucose AUC \<70 mg/dL (hypoglycemia). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model., Baseline, Week 12|Change From Baseline in Number of Hypoglycemic Events/Day (<=70 mg/dL) by Self-Monitored Blood Glucose (SMBG) at Week 12, Hypoglycemic event by SMBG was defined as an event in which the fingerstick measurement was \<=70 mg/dL. The number of hypoglycemic events per day was calculated as a daily average number of episodes over the week prior to visit (Baseline and Week 12). Change was calculated by subtracting baseline value from Week 12 value. LS mean changes from baseline were obtained from MMRM model., Baseline, Week 12
|
| Locations: |
Lexicon Investigational Site, Tustin, California, 92780, United States|Lexicon Investigational Site, Aurora, Colorado, 80045, United States|Lexicon Investigational Site, New Haven, Connecticut, 06519, United States|Lexicon Investigational Site, Tampa, Florida, 33612, United States|Lexicon Investigational Site, West Palm Beach, Florida, 33401, United States|Lexicon Investigational Site, Atlanta, Georgia, 30318, United States|Lexicon Investigational Site, Roswell, Georgia, 30076, United States|Lexicon Investigational Site, Indianapolis, Indiana, 46202, United States|Lexicon Investigational Site, New Orleans, Louisiana, 70121, United States|Lexicon Investigational Site, Auburn, Maine, 04210, United States|Lexicon Investigational Site, Boston, Massachusetts, 02215, United States|Lexicon Investigational Site, Buffalo, New York, 14222, United States|Lexicon Investigational Site, Wilmington, North Carolina, 28401, United States|Lexicon Investigational Site, Austin, Texas, 78749, United States|Lexicon Investigational Site, Salt Lake City, Utah, 84107, United States
|
