A Phase 1 interventional study of Faster-acting insulin aspart and Faster-acting insulin aspart in Diabetes and Diabetes Mellitus, Type 1, sponsored by Novo Nordisk A/S. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-01-09.
Sponsored by Novo Nordisk A/S · Phase 1, Interventional, and Treatment
This trial is conducted in the United States of America (USA). The aim of the trial is to evaluate continuous subcutaneous infusion of NN1218 formulations and NovoLog® in subjects with type 1 diabetes.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's enrollment of 43 is below the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
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Of its 198 completed or terminated interventional studies of FDA-regulated products, 94 (47%) have results posted.
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Exclusion Criteria:
Drug: Faster-acting insulin aspart
Drug: Faster-acting insulin aspart
Drug: insulin aspart
Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.
Also known as: NN1218
Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.
Also known as: NN1218
Administration: Subcutaneous infusion. The subjects will remain on their own pump during the trial. Subjects will have blinded continuous glucose monitoring (CGM) throughout the trial (3 treatment periods of 14 days) and meal tests consisting of a standardised breakfast (liquid meal) will be performed on the 14th day of each treatment period.
Mean change in plasma glucose concentration
Time frame: From 0-2 hours after administration of standardised meal after the first, the second, and the third 14-day treatment period
Self-measured plasma glucose (SMPG) 7-point profile
Time frame: After the first, the second, and the third 14-day treatment period
Self-measured plasma glucose (SMPG) 9-point profile
Time frame: After the first, the second, and the third 14-day treatment period
Number of adverse events (AEs) (including infusion site reactions/infections)
Time frame: Days 0-14 for each treatment periods
Number of hypoglycaemic episodes
Time frame: Days 0-14 for each treatment period
Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG)
Time frame: Days 0-14 for each treatment period
Number of episodes of infusion set occlusions
Time frame: Days 0-14 for each treatment period
This study is completed, as verified in Jan 2017. You cannot join it, but the record below documents what was studied.
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Novo Nordisk A/S