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
Phase 3
Completed
- Conditions
- DiabetesDiabetes Mellitus, Type 1
- Registration Number
- NCT00725036
- Lead Sponsor
- Novo Nordisk A/S
- 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 1 diabetes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 305
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Long term pulmonary safety profiles during treatment
- Secondary Outcome Measures
Name Time Method Glycaemic control as measured by HbA1c Physical examination and body weight and vital signs Adverse events Treatment satisfaction Incidence of hypoglycaemic episodes Long-term safety profiles (laboratory, ECG, insulin antibodies)
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇦🇺Stones Corner, Australia