Status:
TERMINATED
Efficacy and Safety of Inhaled Insulin Compared to Metformin and Glimepiride in Type 2 Diabetes
Lead Sponsor:
Novo Nordisk A/S
Conditions:
Diabetes
Diabetes Mellitus, Type 2
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This trial is conducted in Europe, Asia, North America and South America. The aim of this research trial is to compare the efficacy of inhaled insulin to glimepiride and metformin combination therapy ...
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
- Treated with OADs for more than or equal to 3 months
- HbA1c greater than or equal to 8.0% and less than or equal to 11.0%
- Body Mass Index (BMI) less than or equal to 40.0 kg/m2
Exclusion
- Recurrent major hypoglycaemia
- Current smoking or smoking within the last 6 months
- Impaired hepatic or renal function
- Cardiac problems
- Uncontrolled hypertension
- Proliferative retinopathy or maculopathy
Key Trial Info
Start Date :
April 26 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 24 2008
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT00469586
Start Date
April 26 2007
End Date
April 24 2008
Last Update
March 1 2017
Active Locations (59)
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1
Novo Nordisk Investigational Site
Buenos Aires, Argentina, B1636DSU
2
Novo Nordisk Investigational Site
Buenos Aires, Argentina, C1425AGC
3
Novo Nordisk Investigational Site
Mar del Plata, Argentina, B7600FZN
4
Novo Nordisk Investigational Site
Mendoza, Argentina, 5500