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

Last updated: February 28, 2017
Sponsor: Novo Nordisk A/S
Overall Status: Completed

Phase

3

Condition

Diabetes Mellitus, Type 1

Diabetic Macular Edema

Diabetic Retinopathy

Treatment

N/A

Clinical Study ID

NCT00725036
NN1998-1496
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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

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

Study Design

Total Participants: 305
Study Start date:
September 02, 2002
Estimated Completion Date:
December 14, 2004

Connect with a study center

  • Novo Nordisk Investigational Site

    Broadmeadow, New South Wales 2292
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Camperdown, New South Wales 2050
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    St Leonards, New South Wales 2065
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Wollongong, New South Wales 2500
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Woolloongabba, Queensland 4102
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Keswick, South Australia 5035
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Fremantle, Western Australia 6160
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Ashford, 5035
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Auckland,
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Box Hill, 3128
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Christchurch,
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Clayton, 3168
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Garran, 2605
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Heidelberg, 3085
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Parkville, 3050
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Perth, 6000
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Randwick, 2031
    Australia

    Site Not Available

  • Novo Nordisk Investigational Site

    Stones Corner, 4120
    Australia

    Site Not Available

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