Safety and Efficacy of Inhaled Insulin in Type 1 Diabetes
Phase 3
Terminated
- Conditions
- Diabetes Mellitus, Type 1Diabetes
- Interventions
- Registration Number
- NCT00322257
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This trial is conducted in the United States of America (USA) and Canada. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function, chest x-rays) of mealtime inhaled insulin with subcutaneous insulin aspart both in combination with insulin determir in Type 1 Diabetes.
- Detailed Description
The decision to discontinue the development of AERx® is not due to any safety concerns. An analysis concluded that fast-acting inhaled insulin in the form it is known today, is unlikely to offer significant clinical or convenience benefits over injections of modern insulin with pen devices.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 596
Inclusion Criteria
- Type 1 diabetes
- HbA1c less than or equal to 11%
- Body mass index (BMI) less than or equal to 40.0 kg/m2
Exclusion Criteria
- Total daily insulin dosage more than 100 IU or U/day.
- Current smoking or smoking within the last 6 months
- Impaired hepatic or renal function
- Cardiac problems
- Uncontrolled hypertension
- Current proliferative retinopathy or maculopathy requiring acute treatment
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A inhaled human insulin - A insulin detemir - B insulin aspart - B insulin detemir -
- Primary Outcome Measures
Name Time Method HbA1c After 52 weeks
- Secondary Outcome Measures
Name Time Method Pulmonary Function For the duration of the trial Body weight after 52 weeks Antibodies after 52 weeks Insulin doses For the duration of the trial Fasting plasma glucose after 52 weeks Hypoglycemia For the duration of the trial
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇨🇦Vancouver, Canada