A Phase 3 interventional study of rosiglitazone and inhaled human insulin in Diabetes and Diabetes Mellitus, Type 2, sponsored by Novo Nordisk A/S. Terminated at 74 sites in 9 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-03-01.
Sponsored by Novo Nordisk A/S · Phase 3, Interventional, and Treatment
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 treatment of type 2 diabetes and to verify its safety (hypoglycaemia, pulmonary function, body weight, insulin antibodies and side effects).
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 301 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: inhaled human insulin · Drug: metformin
Drug: rosiglitazone · Drug: metformin
Tablets, 4 mg once or twice daily.
Treat-to-target dose titration scheme, inhalation.
Also known as: NN1998
Tablets, 2000 mg/day.
Treatment difference in HbA1c
Time frame: After 26 weeks
Adverse events
Time frame: For the duration of the trial
Body weight
Time frame: For the duration of the trial
Lung function
Time frame: For the duration of the trial
Blood glucose
Time frame: For the duration of the trial
Hypoglycaemia
Time frame: For the duration of the trial
This study is terminated, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S