Conditions: Diabetes, Type 1
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 130
Healthy volunteers: no

Brief summary:
The objective of this study is to demonstrate that TI® Inhalation Powder combined with Lantus® is as effective as Humalog® combined with Lantus® on HbA1c.

Detailed description:

Arms:
arm 1: Technosphere Insulin Inhalation Powder in combination with Lantus (insulin glargine) arm 2: Humalog (insulin lispro) in combination with Lantus (insulin glargine)

Interventions: intervention 1: Technosphere Insulin intervention 2: Insulin glargine intervention 3: Insulin lispro
Intervention descriptions: intervention 1: Technosphere Insulin Inhalation Powder 15U or 30U intervention 2: Lantus-injectible supplied as 3mL (300 units) pens intervention 3: Humalog autopen cartridges pre-filled with 3mL (300 units)

Protocol document: