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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.
Sponsor:
Information provided by:
Novo Nordisk
ClinicalTrials.gov Identifier:
NCT00725036
First received: July 29, 2008
Last updated: July 9, 2012
Last verified: July 2012
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Long Term Safety Trial Comparing Intensive Treatment of Pulmonary Inhaled Human Insulin With s.c. Insulin Aspart, Both in Combination With NPH, in Subjects With Type 1 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Novo Nordisk:

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

Secondary Outcome Measures:
  • Glycaemic control as measured by HbA1c [ Designated as safety issue: No ]
  • Incidence of hypoglycaemic episodes [ Designated as safety issue: Yes ]
  • Long-term safety profiles (laboratory, ECG, insulin antibodies) [ Designated as safety issue: Yes ]
  • Physical examination and body weight and vital signs [ Designated as safety issue: No ]
  • Adverse events [ Designated as safety issue: Yes ]
  • Treatment satisfaction [ Designated as safety issue: No ]

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00725036

Locations
Australia
Wollongong, Australia, 2500
New Zealand
Christchurch, New Zealand
Sponsors and Collaborators
Novo Nordisk
Investigators
Study Director: Alice Vesterager Novo Nordisk
  More Information

Additional Information:
Clinical Trials at Novo Nordisk  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Public Access to Clinical Trials, Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT00725036     History of Changes
Other Study ID Numbers: NN1998-1496
Study First Received: July 29, 2008
Last Updated: July 9, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
 Insulin aspart
Insulin
Insulin, NPH
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013