A Phase3, Multi-Center, Open-Label, Randomized, Clinical Trial Evaluating the Efficacy and Safety of Technosphere® Insulin Inhalation Powder in Combination With Lantus® Versus Humalog® in Combination With Lantus® in Subjects With Type 1 Diabetes Mellitus Over a 16-Week Treatment Period

NCT00700622 Phase 3 TERMINATED Results posted

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.

Details

Lead sponsor	Mannkind Corporation
Phase	Phase 3
Status	TERMINATED
Enrolment	130
Start date	2008-05
Completion	2010-03

Conditions

• Diabetes, Type 1

Interventions

• Technosphere Insulin
• Insulin glargine
• Insulin lispro

Primary outcomes

• Change From Baseline in HbA1c to Week 16 — Baseline to Week 16
  Change from Baseline in glycosylated hemoglobin at Week 16

Countries

United States, Brazil