Status:
TERMINATED
Safety and Efficacy of Inhaled Insulin in Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18-99 years
Phase:
PHASE3
Brief Summary
This trial is conducted in Asia, Europe and South America. The aim of this research is to compare the efficacy (reduction in HbA1c and blood glucose) and pulmonary safety (pulmonary function tests, ch...
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 2 diabetes
- Currently treated with insulin
- Body mass index of (BMI) less than or equal to 40.0 kg/m2
- HbA1c less than or equal to 11.0%
Exclusion
- Total daily insulin dosage less than or equal to 100 IU or U/day
- Current smoking or smoking within the last 6 months
- Cardiac problems
- Uncontrolled hypertension
- Current proliferative retinopathy or maculopathy
Key Trial Info
Start Date :
August 31 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 5 2008
Estimated Enrollment :
618 Patients enrolled
Trial Details
Trial ID
NCT00331604
Start Date
August 31 2006
End Date
May 5 2008
Last Update
March 1 2017
Active Locations (73)
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1
Novo Nordisk Investigational Site
Campinas, Brazil, 13083-900
2
Novo Nordisk Investigational Site
Higienópolis, Brazil, 01244-030
3
Novo Nordisk Investigational Site
Porto Alegre, Brazil, 90035-170
4
Novo Nordisk Investigational Site
São Paulo, Brazil, 04022-001