Status:
COMPLETED
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
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 1
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 2 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 14 2004
Estimated Enrollment :
305 Patients enrolled
Trial Details
Trial ID
NCT00725036
Start Date
September 2 2002
End Date
December 14 2004
Last Update
March 1 2017
Active Locations (18)
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1
Novo Nordisk Investigational Site
Broadmeadow, New South Wales, Australia, 2292
2
Novo Nordisk Investigational Site
Camperdown, New South Wales, Australia, 2050
3
Novo Nordisk Investigational Site
St Leonards, New South Wales, Australia, 2065
4
Novo Nordisk Investigational Site
Wollongong, New South Wales, Australia, 2500