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Completed

NCT Number: NCT00725036

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 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.

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Key information

Conditions

Diabetes Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novo Nordisk Investigational Site, Broadmeadow, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

inhaled human insulin

Drug

insulin aspart

Drug

insulin NPH

Drug

Primary outcomes

  1. Long term pulmonary safety profiles

    Time frame: during treatment

Secondary outcomes

  1. Glycaemic control as measured by HbA1c

  2. Incidence of hypoglycaemic episodes

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

  4. Physical examination and body weight and vital signs

  5. Adverse events

  6. Treatment satisfaction

Sponsors and collaborators

Lead sponsor

Novo Nordisk A/S

Industry

Registry information

Official study 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

Important dates

Study start
2002
Primary completion
2004
Study completion
2004
First posted
Jul 30, 2008
Registry last updated
Mar 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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