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

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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)

299 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: Human Insulin Inhalation Powder
2
Active Comparator group
Treatment:
Drug: injected insulin

Trial contacts and locations

101

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Data sourced from clinicaltrials.gov

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