Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Africa. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions in Egypt.
Interventions
DRUGinsulin detemir
Start dose and frequency to be prescribed by the physician as a result of the actual clinical evaluation
Sponsors
Novo Nordisk A/S
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* After the physician decision has been made to use insulin detemir, any subject with Type 1 or Type 2 diabetes mellitus is eligible for the study, including newly-diagnosed subjects who have never received insulin or an insulin analogue before. The selection of the subjects will be at the discretion of the individual physician.
Exclusion criteria
* Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit; * Subjects currently being treated with insulin detemir; * Subjects who previously enrolled in this study * Subjects with a hypersensitivity to insulin detemir or to any of the excipients * Pregnancy, breast-feeding, the intention to become pregnant or judged not to be using adequate contraceptive measures. (Adequate contraceptive measures are an intrauterine device, oral contraceptives and barrier methods)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious ADRs incl. major hypoglycemias | after 24 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Number of all adverse events | after 24 weeks |
| Weight changes | after 24 weeks |
| HbA1c | after 24 weeks |
| Number of serious adverse events | after 24 weeks |
| Number of all hypoglycemic events | in the 4 weeks preceding the visits at 12 weeks and 24 weeks. |
| Variability in fasting Blood Sugar and average plasma glucose levels | after 24 weeks |
| Subgroup analysis of hypoglycemias | after 24 weeks |
Countries
Egypt
Outcome results
None listed