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Study of Human Insulin Inhalation Powder in Patients With Type 1 Diabetes

Lilly logo

Lilly

Status and phase

Completed
Phase 3

Conditions

Diabetes Mellitus, Type 1

Treatments

Drug: Human Insulin Inhalation Powder
Drug: Injectable Insulin
Drug: Insulin Glargine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00127634
H7U-MC-IDAH
6120

Details and patient eligibility

About

This is a phase 3, open-label, randomized study to evaluate the safety and efficacy of the Lilly/Alkermes inhaled insulin system compared to injected pre-meal insulin in non-smoking patients with type 1 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.

Enrollment

385 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Type 1 diabetes
  • Non smoker
  • Normal lung function

Exclusion criteria

  • Significant pulmonary, hepatic, or renal disease
  • Severe congestive heart failure
  • Active malignancy
  • Systemic glucocorticoid therapy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

385 participants in 2 patient groups

1
Experimental group
Treatment:
Drug: Insulin Glargine
Drug: Human Insulin Inhalation Powder
2
Active Comparator group
Treatment:
Drug: Insulin Glargine
Drug: Injectable Insulin

Trial contacts and locations

61

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Data sourced from clinicaltrials.gov

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