Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
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.
Interventions
DRUGFaster-acting 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.
DRUGinsulin 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.
Sponsors
Novo Nordisk A/S
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes mellitus (diagnosed clinically) for at least 12 months prior to the screening visit (Visit 1) * Treatment with the same insulin analogue by CSII (continuous subcutaneous insulin infusion) for the previous 3 months prior to the screening visit (Visit 1) * Using a MiniMed Paradigm® pump (515/715, 522/722 or 523/723) for the previous 6 months prior to the screening visit (Visit 1) * Glycosylated haemoglobin (HbA1c) below or equal to 9.0% by central laboratory * Body Mass Index (BMI) below or equal to 35.0 kg/m\^2
Exclusion criteria
* History of diabetic ketoacidsosis (DKA) episodes requiring hospitalization within 6 months prior to the screening visit (Visit 1) * History of abscess at the infusion site within 6 months prior to the screening visit (Visit 1) * Hypoglycaemic unawareness as judged by the Investigator or history of severe hypoglycaemic episodes requiring hospitalization within the last 6 months prior to the screening visit (Visit 1)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change in plasma glucose concentration | From 0-2 hours after administration of standardised meal after the first, the second, and the third 14-day treatment period |
Secondary
| Measure | Time frame |
|---|---|
| Self-measured plasma glucose (SMPG) 9-point profile | After the first, the second, and the third 14-day treatment period |
| Number of adverse events (AEs) (including infusion site reactions/infections) | Days 0-14 for each treatment periods |
| Self-measured plasma glucose (SMPG) 7-point profile | After the first, the second, and the third 14-day treatment period |
| Number of unexplained self-reported episodes of hypoglycaemia or hyperglycaemia (confirmed by SMPG) | Days 0-14 for each treatment period |
| Number of episodes of infusion set occlusions | Days 0-14 for each treatment period |
| Number of hypoglycaemic episodes | Days 0-14 for each treatment period |
Countries
United States
Outcome results
None listed