Evaluate the Efficacy and Safety of Insulin in Patients With Type 2 Diabetes

A Phase 3, Open-Label, Three-Group Parallel Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) in Patients With Type 2 Diabetes Treated With Once-Daily Insulin Glargine

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00355849

Enrollment

555

Registered

2006-07-25

Start date

2006-08-31

Completion date

2008-06-30

Last updated

2019-09-16

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

Conditions

Diabetes Mellitus, Type 2

Brief summary

A study to evaluate the efficacy and safety of Human Insulin Inhalation Powder \[also known as AIR® Inhaled Insulin\]\[AIR® is a registered trademark of Alkermes,Inc.\] in patients with Type 2 diabetes who are currently being treated with once daily insulin glargine injections. The present study is intended to determine if mealtime AIR® Insulin may be superior to once-daily insulin glargine injections.

Interventions

DRUGHuman Insulin Inhalation Powder

patient specific dose, inhaled, before meals, 52 weeks

DRUGInsulin Glargine

patient specific dose, injectable, before meals, 52 weeks

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 2 diabetes mellitus * one or more oral antihyperglycemic medications * once-daily insulin glargine * HbA1c greater than or equal to 7.5 and less than or equal to 10.5% * Non-smoker

Exclusion criteria

* taking a TZD dose greater than what is indicated * more than two episodes of severe hypoglycemia during the 6 months prior * Have had a lower respiratory infection in the 3 months prior * systemic glucocorticoid therapy * clinical signs or symptoms of liver disease, acute or chronic hepatitis * history of renal transplantation * Have an active or untreated malignancy * Require more than 150 U/day of insulin glargine

Design outcomes

Primary

Measure	Time frame
To compare in patients who at study entry have type 2 diabetes not optimally controlled by one or more oral antihyperglycemic medications plus once daily insulin glargine, a regimen that may include mealtime AIR Insulin.	24 weeks

Secondary

Measure	Time frame
To measure changes in HbA1c over time	24 weeks
To assess insulin dose requirements	24 and 52 weeks
To assess rate and incidence of hypoglycemia	24 and 52 weeks

Countries

Brazil, Canada, Germany, India, Israel, Puerto Rico, Russia, South Africa, South Korea, Spain, United Kingdom, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 9, 2026