Effect of Inhaled Insulin (AERx® iDMS) on Blood Glucose Control in Type 2 Diabetes
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 treatment alone.
Diabetes Mellitus, Type 2
Drug: inhaled human insulin
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Effect of Inhaled Insulin (AERx® iDMS) Plus Pioglitazone Versus Pioglitazone Alone on HbA1c in Subjects With Type 2 Diabetes|
- HbA1c change from baseline [ Time Frame: After 26 weeks of treatment ] [ Designated as safety issue: No ]
- Fasting plasma glucose [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
- Lipid profiles [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
- Frequency of hypoglycaemic episodes [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
- Glucose profiles [ Time Frame: at pre- and post meals, bedtime and 3:00 am ] [ Designated as safety issue: No ]
- Change in body weight [ Time Frame: after 26 weeks of treatment ] [ Designated as safety issue: No ]
|Study Start Date:||November 2006|
|Study Completion Date:||March 2008|
|Primary Completion Date:||March 2008 (Final data collection date for primary outcome measure)|
Tablets, 45 mg/day.Drug: inhaled human insulin
Treat-to-target dose titration scheme, inhalation.
Other Name: NN1998
|Active Comparator: B||
Tablets, 45 mg/day.
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 significant clinical or convenience benefits over injections of modern insulin with pen devices.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00411892
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|Study Director:||Theresa Brennan||Novo Nordisk A/S|