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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
43
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.
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.
Novo Nordisk Investigational Site
Atlanta, Georgia, United States
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
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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.