Safety and Efficacy of Inhaled Insulin in Patients With Diabetes and Asthma or COPD

Lilly

Status and phase: Completed; Phase 3

Conditions: Asthma; Diabetes Mellitus; Pulmonary Disease, Chronic Obstructive

Treatments: Drug: injected insulin; Drug: Human Insulin Inhalation Powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT00157339

H7U-MC-IDAS (Other Identifier)

7091

Details and patient eligibility

About

Phase 3 , open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected insulin in type 1 and type 2 diabetes patients with asthma or COPD. Patients will be treated for 12 months with a 2 month follow up period.

Enrollment: 299 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Type 1 or type 2 diabetes
• asthma or COPD

Exclusion criteria

• Current smoking habit

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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299 participants in 2 patient groups

1

Experimental group

Treatment:

Drug: Human Insulin Inhalation Powder

2

Active Comparator group

Treatment:

Drug: injected insulin