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

February 28, 2017 updated by: Novo Nordisk A/S

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

305

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Australia
- - Ashford, Australia, 5035
    - Novo Nordisk Investigational Site
  - Auckland, Australia
    - Novo Nordisk Investigational Site
  - Box Hill, Australia, 3128
    - Novo Nordisk Investigational Site
  - Christchurch, Australia
    - Novo Nordisk Investigational Site
  - Clayton, Australia, 3168
    - Novo Nordisk Investigational Site
  - Garran, Australia, 2605
    - Novo Nordisk Investigational Site
  - Heidelberg, Australia, 3085
    - Novo Nordisk Investigational Site
  - Parkville, Australia, 3050
    - Novo Nordisk Investigational Site
  - Perth, Australia, 6000
    - Novo Nordisk Investigational Site
  - Randwick, Australia, 2031
    - Novo Nordisk Investigational Site
  - Stones Corner, Australia, 4120
    - Novo Nordisk Investigational Site
- New South Wales
  - Broadmeadow, New South Wales, Australia, 2292
    - Novo Nordisk Investigational Site
  - Camperdown, New South Wales, Australia, 2050
    - Novo Nordisk Investigational Site
  - St Leonards, New South Wales, Australia, 2065
    - Novo Nordisk Investigational Site
  - Wollongong, New South Wales, Australia, 2500
    - Novo Nordisk Investigational Site
- Queensland
  - Woolloongabba, Queensland, Australia, 4102
    - Novo Nordisk Investigational Site
- South Australia
  - Keswick, South Australia, Australia, 5035
    - Novo Nordisk Investigational Site
- Western Australia
  - Fremantle, Western Australia, Australia, 6160
    - Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Long term pulmonary safety profiles Time Frame: during treatment	during treatment

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Clinical Trials at Novo Nordisk

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 2, 2002

Primary Completion (Actual)

December 14, 2004

Study Completion (Actual)