Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Asia. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions while using insulin detemir under normal clinical practice conditions in the Gulf countries
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
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
6 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* After the physician decision has been made to use insulin detemir therapy, any subject with Type 2 diabetes 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 or studies related to NovoMix 30; * Subjects with a hypersensitivity to insulin detemir or to any of the excipients; * Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 8 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of serious adverse drug reactions, evaluated via number of major hypoglycaemic events | For the duration of the study (32 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Number of all adverse events | For the duration of the study |
| Number of all - daytime and nocturnal - hypoglycaemic events | In the 4 weeks before baseline compared to 4 weeks before interim and final visits |
| Number of serious adverse events | For the duration of the study |
| HbA1c compared to baseline | At the end of the study |
| Fasting glucose level control compared to baseline as measured by FBG | After 16 and 32 weeks of treatment |
| Weight changes compared to baseline | At the end of the study |
Countries
Saudi Arabia
Outcome results
None listed