Conditions: Type 1 Diabetes Mellitus
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 518
Healthy volunteers: no

Brief summary:
Open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of TI Inhalation Power in combination with a basal insulin versus insulin aspart in combination with a basal insulin

Detailed description:
Phase 3 clinical trial designed to examine the efficacy and safety of inhaled prandial TI Inhalation Power in combination with basal insulin versus insulin aspart in combination with basal insulin in subjects with type 1 diabetes who are suboptimally controlled with their current insulin regimens. This trial will employ a variety of methods to intensively manage these subjects.

Arms:
arm 1: Subjects will receive TI with the MedToneC inhaler and remain on the basal insulin they were taking prior to study entry arm 2: Subjects will receive insulin aspart and remain on the basal insulin they were taking prior to study entry arm 3: Subject will receive Technosphere Insulin with Gen2 Inhaler and remain on the basal insulin they were taking prior to study entry

Interventions: intervention 1: Technosphere® Insulin with MedTone C Inhaler intervention 2: Technosphere ®Insulin with Gen2 Inhaler intervention 3: Insulin Aspart in combination with a basal insulin
Intervention descriptions: intervention 1: Inhalation Powder and injectable insulin intervention 2: Inhalation Powder and injectable insulin intervention 3: Injectable insulin

Protocol document: