to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
547
Inhalation, 15U/30U, prandial
Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations.
Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets
Difference in Change From Baseline for HbA1c Between TI+ Metformin and Metformin+Secretagogue
Time frame: Baseline to Week 12
Difference in Change From Baseline for HbA1c Between TI Alone and Metformin+Secretagogue
(Change from baseline within TI Alone) minus (change from baseline within metformin + secretagogue)
Time frame: Baseline to Week 12
Change in HbA1c From Baseline to Week 24 (Subjects Who Stayed on Original Treatment)
Time frame: Week 24
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