Conditions: Diabetes Type 2
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 677
Healthy volunteers: no

Brief summary:
The purpose of this 13 month study (12 month treatment period and 1 month follow-up period) is to determine whether inhaled insulin is safe and effective in the treatment of type 2 diabetes.

Detailed description:

Arms:
arm 1: Technosphere® Insulin Inhalation Powder + insulin glargine arm 2: 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)

Interventions: intervention 1: Technosphere® Insulin Inhalation Powder intervention 2: 70% insulin aspart protamine suspension and 30% insulin aspart injection (rDNA origin)
Intervention descriptions: intervention 1: Inhalation, 15U/30U intervention 2: BPR 70/30, which is a premix of intermediate acting and rapid acting insulin given sc

Protocol document: