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

Novo Nordisk A/S305 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

305

Conditions

Diabetes Diabetes Mellitus, Type 1

Interventions

inhaled human insulinDRUG

insulin aspartDRUG

insulin NPHDRUG

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (18)

Novo Nordisk Investigational Site

Broadmeadow, New South Wales, Australia

Novo Nordisk Investigational Site

Camperdown, New South Wales, Australia

Outcomes

Primary Outcomes

Long term pulmonary safety profiles

Time frame: during treatment

Secondary Outcomes

Glycaemic control as measured by HbA1c

Incidence of hypoglycaemic episodes

Long-term safety profiles (laboratory, ECG, insulin antibodies)

Physical examination and body weight and vital signs

Adverse events

Treatment satisfaction

Data from ClinicalTrials.gov

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