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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

This study has been completed.
Information provided by (Responsible Party):
Novo Nordisk A/S Identifier:
First received: July 29, 2008
Last updated: February 28, 2017
Last verified: February 2017

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.

Condition Intervention Phase
Diabetes Diabetes Mellitus, Type 1 Drug: inhaled human insulin Drug: insulin aspart Drug: insulin NPH Phase 3

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

Resource links provided by NLM:

Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Long term pulmonary safety profiles [ Time Frame: during treatment ]

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

Enrollment: 305
Actual Study Start Date: September 2, 2002
Study Completion Date: December 14, 2004
Primary Completion Date: December 14, 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00725036

Australia, New South Wales
Novo Nordisk Investigational Site
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
Australia, Queensland
Novo Nordisk Investigational Site
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Novo Nordisk Investigational Site
Keswick, South Australia, Australia, 5035
Australia, Western Australia
Novo Nordisk Investigational Site
Fremantle, Western Australia, Australia, 6160
Novo Nordisk Investigational Site
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
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
Responsible Party: Novo Nordisk A/S Identifier: NCT00725036     History of Changes
Other Study ID Numbers: NN1998-1496
Study First Received: July 29, 2008
Last Updated: February 28, 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin degludec, insulin aspart drug combination
Isophane insulin, beef
Insulin Aspart
Insulin, Long-Acting
Isophane Insulin, Human
Insulin, Isophane
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on September 20, 2017