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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

Primary Purpose

Diabetes, Diabetes Mellitus, Type 1

Status
Completed
Phase
Phase 3
Locations
Australia
Study Type
Interventional
Intervention
inhaled human insulin
insulin aspart
insulin NPH
Sponsored by
Novo Nordisk A/S
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetes

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site
  • Novo Nordisk Investigational Site

Outcomes

Primary Outcome Measures

Long term pulmonary safety profiles

Secondary Outcome Measures

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

Full Information

First Posted
July 29, 2008
Last Updated
February 28, 2017
Sponsor
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT00725036
Brief Title
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
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
September 2, 2002 (Actual)
Primary Completion Date
December 14, 2004 (Actual)
Study Completion Date
December 14, 2004 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Novo Nordisk A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes, Diabetes Mellitus, Type 1

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
305 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
inhaled human insulin
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Type
Drug
Intervention Name(s)
insulin NPH
Primary Outcome Measure Information:
Title
Long term pulmonary safety profiles
Time Frame
during treatment
Secondary Outcome Measure Information:
Title
Glycaemic control as measured by HbA1c
Title
Incidence of hypoglycaemic episodes
Title
Long-term safety profiles (laboratory, ECG, insulin antibodies)
Title
Physical examination and body weight and vital signs
Title
Adverse events
Title
Treatment satisfaction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Global Clinical Registry (GCR, 1452)
Organizational Affiliation
Novo Nordisk A/S
Official's Role
Study Director
Facility Information:
Facility Name
Novo Nordisk Investigational Site
City
Broadmeadow
State/Province
New South Wales
ZIP/Postal Code
2292
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Wollongong
State/Province
New South Wales
ZIP/Postal Code
2500
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Keswick
State/Province
South Australia
ZIP/Postal Code
5035
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Fremantle
State/Province
Western Australia
ZIP/Postal Code
6160
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Ashford
ZIP/Postal Code
5035
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Auckland
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Box Hill
ZIP/Postal Code
3128
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Christchurch
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Clayton
ZIP/Postal Code
3168
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Garran
ZIP/Postal Code
2605
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Heidelberg
ZIP/Postal Code
3085
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Parkville
ZIP/Postal Code
3050
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Perth
ZIP/Postal Code
6000
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Randwick
ZIP/Postal Code
2031
Country
Australia
Facility Name
Novo Nordisk Investigational Site
City
Stones Corner
ZIP/Postal Code
4120
Country
Australia

12. IPD Sharing Statement

Links:
URL
http://novonordisk-trials.com
Description
Clinical Trials at Novo Nordisk

Learn more about this trial

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

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