Study of Human Insulin Inhalation Powder in Patients With Type 2 Diabetes

A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naive Patients With Type 2 Diabetes Mellitus.

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00325364

Enrollment

415

Registered

2006-05-12

Start date

2006-04-30

Completion date

2008-05-31

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

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 2 diabetes. Patients will be treated for 24 months with a 2-month follow-up period.

Interventions

DRUGHuman Insulin Inhalation Powder

patient specific dose, inhaled, before meals, 24 months

DRUGInjectable insulin

patient specific dose, injectable, before meals, 24 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 2 diabetes * Non smoker * Normal lung function

Exclusion criteria

* Pulmonary, hepatic, or renal disease * Congestive heart failure * Active malignancy * Systemic glucocorticoid therapy

Design outcomes

Primary

Measure	Time frame
To assess the change in baseline to endpoint in HbA1c in Type II diabetic patients comparing inhaled human insulin to injectable insulin	6 months

Secondary

Measure	Time frame
To compare inhaled human insulin to injectable insulin over time with respect to change on body weight	baseline and every visit
To compare inhaled human insulin to injectable insulin over time with respect to patient satisfaction	baseline, 6 months, 12 months, 18 months, 24 months
To compare inhaled human insulin to injectable insulin over time with respect to percentage of patients achieving good glucose control as measured by HbA1c	baseline and every visit
To compare inhaled human insulin to injectable insulin over time with respect to safety based on reported adverse events, lab tests, chest x-rays, pulmonary function tests, & episodes of hypoglycemia	throughout the study
To test the hypothesis that inhaled human insulin is non-inferior to preprandial injectable insulin	24 months
To test dose titration methods	6 months
To assess inhaler reliability	throughout the study
To assess the pharmacokinetics on inhaled human insulin in a subgroup of patients	3 months, 6 months
To compare inhaled human insulin to injectable insulin over time with respect to insulin dose requirements	24 months

Countries

Brazil, Germany, Hungary, India, Italy, Mexico, Poland, Portugal, Puerto Rico, Taiwan, United States

Outcome results

None listed

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