Long Term Safety Trial to Compare Insulin Treatment With Preprandial Inhaled Human Insulin to s.c. Insulin Aspart Both Combined With NPH in Subjects With Type 1 Diabetes

A 24-month Multicentre, Open-label, Randomised, Parallel Group, Long Term Safety Trial Comparing Intensive Treatment of Pulmonary Inhaled Human Insulin With Insulin Aspart Administered s.c., Both in Combination With NPH, in Subjects With Type 1 Diabetes

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00725036

Enrollment

305

Registered

2008-07-30

Start date

2002-09-02

Completion date

2004-12-14

Last updated

2017-03-01

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

Conditions

Diabetes, Diabetes Mellitus, Type 1

Brief summary

This trial is conducted in Oceania. The aim of this trial is to compare the safety of using pulmonary inhaled human insulin to s.c. insulin aspart both combined with NPH insulin in subjects with type 1 diabetes.

Interventions

DRUGinhaled human insulin

DRUGinsulin aspart

DRUGinsulin NPH

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 * Current treatment with any insulin in any regimen * Body mass index (BMI) below 38.0 kg/m2 * HbA1c below or equal to 13.0%

Exclusion criteria

* Total daily insulin dosage more than 100 IU/day * Current acute or chronic pulmonary disease (excluding asthma) * Recurrent major hypoglycaemia * Proliferative retinopathy or maculopathy requiring acute treatment * Smoker * Chest X-ray with clinically significant abnormalities

Design outcomes

Primary

Measure	Time frame
Long term pulmonary safety profiles	during treatment

Secondary

Measure	Time frame
Incidence of hypoglycaemic episodes	—
Long-term safety profiles (laboratory, ECG, insulin antibodies)	—
Glycaemic control as measured by HbA1c	—
Adverse events	—
Treatment satisfaction	—
Physical examination and body weight and vital signs	—

Countries

Australia

Outcome results

None listed

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