| Outcome Measures: |
Primary: HbA1c change from baseline (week 2) to end of treatment (week 12), 12 weeks | Secondary: Area under the plasma glucose concentration versus time (AUCglucose), Timepoints: 0, 30, 60, and 120 minutes after TI administration, every 4 weeks|Maximum glucose concentration (Cmax), Timepoints: 0, 30, 60, and 120 minutes after TI administration, every 4 weeks|Time to maximum glucose concentration (tmax), Timepoints: 0, 30, 60, and 120 minutes after TI administration, every 4 weeks|Area under the plasma glucose concentration versus time (AUCglucose), Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration, every 4 weeks|Maximum glucose concentration (Cmax), Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration, every 4 weeks|Time to maximum glucose concentration (tmax), Timepoints: 0, 30, 60, and 120 minutes after Technosphere Placebo administration, every 4 weeks|Safety variables included adverse events (AEs), clinical laboratory tests, vital signs and physical examinations, every 2 weeks
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