Diabetes, Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Asia. The aim of this observational study is to evaluate the safety and efficacy of modern insulins after switch from any other anti-diabetic treatment under normal clinical 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
DRUGbiphasic insulin aspart 30
Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation
DRUGinsulin aspart
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
Healthy volunteers
No
Inclusion criteria
* Type 1 or type 2 diabetes * Treatment with any diabetes treatment other than NovoMix® 30, Levemir® and/or NovoRapid® * Selection will be at the discretion of the individual physician
Exclusion criteria
* Current treatment with Levemir®, NovoMix® 30 and/or NovoRapid® * Previous enrolled in this study * Hypersensitivity to Levemir®, NovoMix® 30 and/or NovoRapid® or to any of the excipients * Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 6 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of major hypoglycaemic events reported | during 24 weeks of treatment |
| Change in HbA1c | during 24 weeks of treatment |
Secondary
| Measure | Time frame |
|---|---|
| Change in number of hypoglycaemic events in the last 4 weeks before routine visits | at 12 & 24 weeks |
| Change in number of nocturnal Hypoglycaemic events in the last 4 weeks before routine visits | at 12 & 24 weeks |
| Change in PPG | at 12 & 24 weeks |
| Percentage of subjects achieving HbA1c below 7.0% | at 12 & 24 weeks |
| Change in FPG | at 12 & 24 weeks |
| Number of adverse drug reactions (ADR) | at 12 & 24 weeks |
| Body weight | at 12 & 24 weeks |
Countries
Saudi Arabia
Outcome results
None listed