Diabetes, Diabetes Mellitus, Type 1
Conditions
Brief summary
This trial is conducted in Europe. The aim is to compare changes in blood sugar and the number of periods where carbohydrate supplementation is needed to treat low blood sugar, during two different treatments with NN1250 (insulin degludec), a soluble insulin basal analogue (SIBA) in subjects with type 1 diabetes.
Interventions
DRUGinsulin degludec
Insulin degludec injected s.c. (under the skin) three times weekly
DRUGplacebo
Placebo injected s.c. (under the skin) four times weekly
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 for at least 12 months * Glycosylated haemoglobin (HbA1c) between 7.5 and 9% (both inclusive)
Exclusion criteria
* Donation or loss of more than 500 ml blood or plasma within three months prior to this trial * Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) or not able or willing to refrain from smoking and the use of nicotine gum or transdermal nicotine patches during the in-house periods * Prior or current treatment with metformin or thiazolidinediones
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total number of periods where carbohydrate supplementation is needed during the treatment | Assessed every day of the two in-house stays of nine days |
Secondary
| Measure | Time frame |
|---|---|
| Frequency of adverse events (AEs) | Assessed every day of the two in-house stays of nine days and one follow-up by telephone |
| Number of periods with low blood sugar during treatment | Assessed every day of the two in-house stays of nine days and one follow-up by telephone |
Countries
Germany
Outcome results
None listed