Conditions: Type 2 Diabetes
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 39
Healthy volunteers: no

Brief summary:
This is an open-label, randomized, forced-titration clinical trial evaluating the efficacy and safety of Technosphere Insulin (TI) Inhalation Powder in combination with insulin glargine versus insulin aspart in combination with insulin glargine in subjects with type 2 diabetes.

Detailed description:
Phase 3 clinical trial is designed to examine the efficacy and safety of inhaled prandial TI Inhalation Powder in combination with basal insulin verses insulin aspart in combination with basal insulin in subjects with type 2 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: Insulin Glargine and Technosphere® Insulin Inhalation Powder arm 2: Insulin Glargine and Insulin Aspart

Interventions: intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: Insulin Aspart intervention 3: Insulin Glargine
Intervention descriptions: intervention 1: None intervention 2: Usual Care intervention 3: None

Protocol document: