A Phase 3 interventional study of pioglitazone and inhaled human insulin in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Terminated at 110 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-09-05.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 196 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Novo Nordisk A/S is the lead sponsor of 1,370 studies on the registry; 102 are open to participants now.
Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: pioglitazone · Drug: inhaled human insulin
Drug: pioglitazone
Tablets, 45 mg/day.
Treat-to-target dose titration scheme, inhalation.
Also known as: NN1998
HbA1c change from baseline
Time frame: After 26 weeks of treatment
Fasting plasma glucose
Time frame: after 26 weeks of treatment
Lipid profiles
Time frame: after 26 weeks of treatment
Frequency of hypoglycaemic episodes
Time frame: after 26 weeks of treatment
Glucose profiles
Time frame: at pre- and post meals, bedtime and 3:00 am
Change in body weight
Time frame: after 26 weeks of treatment
Showing the first 100 of 110 sites.
This study is terminated, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S