Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This trial is conducted in North America. The aim of this trial is to evaluate the safety of insulin detemir for the treatment of diabetes.
Interventions
DRUGinsulin detemir
Administered subcutaneously (s.c., under the skin). Dose individually adjusted.
Sponsors
Novo Nordisk A/S
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Diagnosed with type 1 or type 2 diabetes * Using a basal/bolus insulin regimen
Exclusion criteria
* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit * Subjects who previously enrolled in this study * Subjects with a hypersensitivity to insulin detemir or to any of the excipients
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse drug reactions (SADRs) including major hypoglycaemic events | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of adverse events (all and serious) | — |
| Number of all hypoglycaemic events | — |
| Change in weight | — |
| HbA1c (glycosylated haemoglobin) | — |
| Treatment satisfaction as assessed by Insulin Treatment Satisfaction Questionnaire (ITSQ-22) | — |
Countries
Canada
Outcome results
None listed