Status:
TERMINATED
Safety and Efficacy of Inhaled Pre-prandial Human Insulin 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 Asia, Europe and Oceania. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to glimepiride compared to adding rosiglitazone to ...
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 OAD(s) for more than or equal to 2 months
- Body mass index (BMI) less than or equal to 40.0 kg/m2
- HbA1c greater than or equal to 8.0 % and less than or equal to 11.0 % for subjects in OAD monotherapy
- HbA1c greater than or equal to 7.5 % and less than or equal to 10.0 % for subjects on OAD combination therapy
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 :
October 10 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 10 2008
Estimated Enrollment :
363 Patients enrolled
Trial Details
Trial ID
NCT00343980
Start Date
October 10 2006
End Date
March 10 2008
Last Update
March 1 2017
Active Locations (26)
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1
Novo Nordisk Investigational Site
St Leonards, New South Wales, Australia, 2065
2
Novo Nordisk Investigational Site
Wollongong, New South Wales, Australia, 2500
3
Novo Nordisk Investigational Site
Garran, Australia, 2605
4
Novo Nordisk Investigational Site
Kingswood, Australia, 2747