Status:
TERMINATED
Safety and Efficacy of Inhaled Insulin in 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 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 fun...
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 signi...
Eligibility Criteria
Inclusion
- Type 1 diabetes
- HbA1c less than or equal to 11%
- Body mass index (BMI) less than or equal to 40.0 kg/m2
Exclusion
- 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
Key Trial Info
Start Date :
May 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 2 2008
Estimated Enrollment :
596 Patients enrolled
Trial Details
Trial ID
NCT00322257
Start Date
May 1 2006
End Date
April 2 2008
Last Update
September 5 2018
Active Locations (96)
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1
Novo Nordisk Investigational Site
Birmingham, Alabama, United States, 35294
2
Novo Nordisk Investigational Site
Tuscaloosa, Alabama, United States, 35406
3
Novo Nordisk Investigational Site
Concord, California, United States, 94520
4
Novo Nordisk Investigational Site
Encino, California, United States, 91436