Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial iss conducted in Europe. The aim of this clinical trial is to evaluate the hypoglycaemic response (the response to low blood sugar) to NN1250 (insulin degludec) in subjects with type 1 diabetes. The trial is designed as a two-period, crossover trial where the trial participant is randomised to one of two treatment periods.
Interventions
DRUGinsulin degludec
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
DRUGinsulin glargine
Day 1-4: Once daily subcutaneous (under the skin) injection similar to 80% of individual basal insulin requirement. Day 5: Three times the individual basal insulin requirement.
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 65 Years
Healthy volunteers
No
Inclusion criteria
* Type 1 diabetes mellitus (as diagnosed clinically) for at least 12 months * Body mass index 18.0-28.0 kg/m\^2 (both inclusive)
Exclusion criteria
* Use of insulin glargine within 3 months prior to first dosing of investigational product in this trial * Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening * Smoker * Recurrent severe hypoglycaemia (more than 1 severe hypoglycaemic event during the last 12 months)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Baseline-adjusted hypoglycaemic symptoms score at nadir plasma glucose concentration | Within 0-46 hours after last trial product administration |
Secondary
| Measure | Time frame |
|---|---|
| Baseline-adjusted hypoglycaemic symptoms score at each level of plasma glucose | Within 0-46 hours after last trial product administration |
| Time from start of hypoglycaemic induction until each level of plasma glucose is reached | Within 0-46 hours after last trial product administration |
| Time to increase from nadir plasma glucose to a plasma glucose concentration of 3.9 mmol/L | Within 0-46 hours after last trial product administration |
| Hypoglycaemic symptoms score during recovery from hypoglycaemia | Within 0-46 hours after last trial product administration |
Countries
Austria
Outcome results
None listed