Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This observational study is conducted in Africa. The aim of this observational study is to evaluate the efficacy and the incidence of serious adverse drug reactions while using insulin Levemir® under normal clinical practice conditions.
Interventions
DRUGinsulin detemir
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
Sponsors
Novo Nordisk A/S
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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 * Currently being treated with insulin detemir * Previously enrolled in this study * 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of serious adverse drug reactions, including major hypoglycaemic events | From baseline to 12 and 24 weeks of Levemir® therapy, respectively |
Secondary
| Measure | Time frame |
|---|---|
| Number of all adverse events | From baseline to 12 and 24 weeks of Levemir® therapy, respectively |
| Number of all hypoglycaemic events | in the 4 weeks preceding the visits at 12 weeks and 24 weeks. |
| Number of serious adverse events | From baseline to 12 and 24 weeks of Levemir® therapy, respectively |
| HbA1c | at the end of study |
| Sub -group analysis of hypo risk | From baseline to 12 and 24 weeks of Levemir® therapy, respectively |
| Weight changes | at the end of study |
Countries
Morocco
Outcome results
None listed