Status:
TERMINATED
Efficacy and Safety 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 Europe. The aim of this research study is to compare the efficacy of adding inhaled preprandial insulin to metformin compared to adding rosiglitazone to metformin for the t...
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 of (BMI) less than or equal to 40.0 kg/m2
- HbA1c greater than or equal to 7.5% and less than or equal to 11.0 % for subjects in OAD monotherapy and HbA1c greater than or equal to 7.0% 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 disorders
- Uncontrolled hypertension
- Proliferative retinopathy or maculopathy
Key Trial Info
Start Date :
October 30 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 5 2008
Estimated Enrollment :
301 Patients enrolled
Trial Details
Trial ID
NCT00348712
Start Date
October 30 2006
End Date
March 5 2008
Last Update
March 1 2017
Active Locations (74)
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1
Novo Nordisk Investigational Site
Ebreichsdorf, Austria, 2483
2
Novo Nordisk Investigational Site
Vienna, Austria, 1030
3
Novo Nordisk Investigational Site
Vienna, Austria, 1090
4
Novo Nordisk Investigational Site
Joensuu, Finland, 80130