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:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
First received: July 29, 2008
Last updated: November 21, 2013
Last verified: November 2013

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 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: 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
Study Start Date: September 2002
Study Completion Date: December 2004
Primary Completion Date: December 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00725036

Australia, New South Wales
Wollongong, New South Wales, Australia, 2500
New Zealand
Christchurch, New Zealand
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Alice Vesterager Novo Nordisk A/S
  More Information

Additional Information:
ClinicalTrials.gov Identifier: NCT00725036     History of Changes
Other Study ID Numbers: NN1998-1496 
Study First Received: July 29, 2008
Last Updated: November 21, 2013

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

ClinicalTrials.gov processed this record on January 19, 2017