| Outcome Measures: |
Primary: Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]), Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval., Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B) | Secondary: Percentage of Time Above the Upper Limit of Glycemic Range (Greater Than [>] 7.8 mmol/L [(140 mg/dL]), Percentage of time with glucose above the upper limit of glycemic range (\>7.8 mmol/L) was assessed by the total time above the upper limit of glycemic range divided by the length of the assessment interval., Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|Percentage of Time Below The Lower Limit of Glycemic Range (<4.4 mmol/L [80 mg/dL]), Percentage of time with glucose below the lower limit of glycemic range (\<4.4 mmol/L) was assessed by the total time below the lower limit of glycemic range divided by the length of the assessment interval., Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|Evaluation of Diurnal Glucose Exposure, Variability, and Stability, The diurnal glucose exposure is measured as the average diurnal glucose concentration, diurnal glucose variability is measured by interquartile range (IQR), that is, average distance between the 25th and the 75th point-wise percentiles and diurnal glucose stability is assessed in terms of the mean absolute rate of change (mmol/l), that is, the area under the absolute rate of change of the median curve (based on the median point values between two adjacent hourly basket intervals), divided by the length of the assessment interval., Up to Week 16 (assessed at Weeks 7-8 in Period A and Weeks 15-16 in Period B)|Percentage of Time in Target Plasma Glucose Range (4.4-7.8 mmol/L [80-140 mg/dL]) in the Last Four Hours of Each Dosing Interval at Weeks 7 and 8 in Period A and Weeks 15 and 16 in Period B, Percentage of time with glucose within glycemic range (4.4-7.8 mmol/L) was assessed by the total time within glycemic range divided by the length of the assessment interval., Weeks 7-8 in Period A and Weeks 15-16 in Period B|Change in HbA1c From Baseline to Week 8 and 16, Baseline, Week 8, 16|Change in Fasting Plasma Glucose (FPG) From Baseline to Week 8 and 16, Baseline, Week 8, 16|Change in Average 7-Point Self-Monitored Plasma Glucose (SMPG) Profile From Baseline to Week 8 and 16, Change in average of 7-point SMPG. 7-point SMPG was assessed starting with a measurement at before breakfast and 2 hours after breakfast; before and 2 hours after lunch; before and 2 hours after dinner; at bedtime., Baseline, Week 8, 16|Change in Basal Insulin Daily Dose From Baseline to Week 8 and 16, Baseline, Week 8, 16|Percentage of Participants With Hypoglycemia (All and Nocturnal) Events From Baseline Up to Week 16, Hypoglycemia events were Severe hypoglycemia (an event that required assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions); Documented symptomatic hypoglycemia (typical symptoms of hypoglycemia with plasma glucose level of \<=3.9 mmol/L \[70 mg/dL\]); Asymptomatic hypoglycemia (no typical symptoms of hypoglycemia but plasma glucose level \<=3.9 mmol/L); Probable symptomatic hypoglycemia (an event during which symptoms of hypoglycemia were not accompanied by a plasma glucose determination, but was presumably caused by a plasma glucose level \<=3.9 mmol/L, symptoms treated with oral carbohydrate without a test of plasma glucose); Relative hypoglycemia (an event during which the person with diabetes reported any of the typical symptoms of hypoglycemia, and interpreted the symptoms as indicative of hypoglycemia, but plasma glucose level \>3.9 mmol/L); Severe and/or confirmed a hypoglycemia (plasma glucose \<=3.9 mmol/L)., Up to Week 16
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| Locations: |
Investigational Site Number 840002, Temecula, California, 92591, United States|Investigational Site Number 840001, Minneapolis, Minnesota, 55416, United States|Investigational Site Number 840003, Portland, Oregon, 97201-3098, United States
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