Status:
TERMINATED
Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control 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 the United States of America (USA). This trial will compare the changes in HbA1c after 26 weeks of inhaled insulin and pioglitazone combination therapy versus pioglitazone 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
- Current treatment with oral antidiabetes drugs (OADs) for at least 2 months
- HbA1c between 7.0-11.0% if on OAD monotherapy
- HbA1c between 7.0-10.0% if on OAD combination therapy
- BMI less than or equal to 40 kg/m2
Exclusion
- Current regular smoking or regular smoking within the last 6 months
- Current acute or chronic pulmonary disease (except for asthma)
- Proliferative retinopathy requiring treatment
- Clinically significant disease history including kidney or liver disease, or heart disease which limits physical activity or results in discomfort with physical activity
- Pregnancy
Key Trial Info
Start Date :
November 29 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 18 2008
Estimated Enrollment :
196 Patients enrolled
Trial Details
Trial ID
NCT00411892
Start Date
November 29 2006
End Date
March 18 2008
Last Update
September 5 2018
Active Locations (110)
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1
Novo Nordisk Investigational Site
Ozark, Alabama, United States, 36360
2
Novo Nordisk Investigational Site
Tuscaloosa, Alabama, United States, 35406
3
Novo Nordisk Investigational Site
Vestavia Hills, Alabama, United States, 35209
4
Novo Nordisk Investigational Site
Tucson, Arizona, United States, 85741