Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial was conducted in Europe. The aim of this clinical trial was to evaluate the effect on the blood glucose-lowering effect of NN1250 (insulin degludec) in subjects with type 1 diabetes.
Interventions
DRUGinsulin degludec
Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)
DRUGinsulin glargine
Subjects were randomised to one of three possible dose levels (low, middle or high) and to one of two treatment sequences. A treatment sequence consisted of 2 periods of each 13 days. One dose once daily. The trial products were administered subcutaneously (under the skin)
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 * Current total daily insulin treatment lower than 1.2 (I)U/kg/day * Body mass index 18.0-28.0 kg/m\^2
Exclusion criteria
* Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening * Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) * Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period * Supine blood pressure at screening (after resting for 5 min) outside the range of 90-140 mmHg for systolic or 50-90 mmHg for diastolic
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Area under the glucose infusion rate curve during one dosing interval of Insulin Degludec at steady state | 0-24 hours after dosing on day 8 |
Secondary
| Measure | Time frame |
|---|---|
| Area under the glucose infusion rate curve during one dosing interval of insulin glargine at steady state | 0-24 hours after dosing on day 8 |
| Area under the concentration-time curve during one dosing interval at steady state for Insulin Degludec | 0-24 hours after dosing on day 8 |
| Area under the concentration-time curve during one dosing interval at steady state for insulin glargine | 0-24 hours after dosing on day 8 |
Countries
Germany
Outcome results
None listed