Conditions: Diabetes Mellitus, Type 2
Allocation: RANDOMIZED | Intervention model: CROSSOVER
Enrollment: 547
Healthy volunteers: no

Brief summary:
to demonstrate the efficacy of inhaled Technosphere/Insulin in combination with metformin versus combination metformin and a secretagogue

Detailed description:

Arms:
arm 1: Technosphere Insulin arm 2: Metformin \& Secretagogues arm 3: Technosphere \& Metformin

Interventions: intervention 1: Technosphere Insulin intervention 2: Metformin & Secretagogues intervention 3: Technosphere Insulin & Metformin
Intervention descriptions: intervention 1: Inhalation, 15U/30U, prandial intervention 2: Metformin tablets,Secretagogues supplied as any of the currently marketed brands and formulations. intervention 3: Technosphere Insulin Inhalation Powder 15U/30U, Metformin tablets

Protocol document: