Evaluate the Efficacy of Insulin Patients With Type 1 Diabetes

A Phase 3, Open-Label, Parallel-Group Study to Evaluate the Efficacy of Preprandial Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Patients With Type 1 Diabetes Mellitus

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00356109

Enrollment

494

Registered

2006-07-25

Start date

2006-08-31

Completion date

2008-05-31

Last updated

2018-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1

Brief summary

A study to test for non-inferiority of preprandial HIIP \[also known as AIR® Inhaled Insulin Powder\]\[AIR® is a registered trademark of Alkermes,Inc.\] compared with preprandial injectable insulin (insulin lispro) with respect to HbA1c after 6 months of treatment in patients with type 1 diabetes mellitus. This study is designed also to examine insulin antibody levels in AIR Insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes. The present study is intended to determine if preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint at 6 months in patients with type 1 diabetes.

Interventions

DRUGHuman Insulin Inhalation Powder

patient specific dose, inhaled, before meals, 6 months

DRUGInjectable insulin

patient specific dose, injected, before meals, 6 months

DRUGInsulin Glargine

patient specific dose, injectable, before meals, 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Type 1 diabetes for at least 24 months * Have an HbA1c less than or equal to 11% * Patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months * Non-smoker

Exclusion criteria

* Require a daily total insulin dosage greater than 150 U at screening * Patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease * Systemic glucocorticoid therapy * Clinical signs or symptoms of liver disease, acute or chronic hepatitis * History of lung transplantation and/or lung cancer * Diagnosed with pneumonia in the 3 months prior to screening * History of renal transplantation * Active or untreated malignancy

Design outcomes

Primary

Measure	Time frame
To test that preprandial AIR Insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in HbA1c from baseline to endpoint.	6 months

Secondary

Measure	Time frame
Insulin dose requirements	throughout the study
Insulin antibody binding levels	baseline, 1 month, 6 months, follow-up
To compare HbAlc change	6 months
To assess rate and incidence of hypoglycemia	6 months

Countries

Argentina, Belgium, France, Germany, India, Italy, Mexico, Puerto Rico, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026