Diabetes, Diabetes Mellitus, Type 2
Conditions
Brief summary
This study is conducted in Africa. The aim of this study is to assess the safety and efficacy of Levemir® treatment for insulin naive patients with type 2 diabetes under normal clinical practice conditions in Algeria.
Interventions
DRUGinsulin detemir
Initial dosage and the following dosages will be prescribed by the physician as a result of a normal clinical evaluation
Sponsors
Novo Nordisk A/S
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent obtained before any trial-related activities * Type 2 diabetes * HbA1c between 7-9% * Insulin naive * Inadequate control with oral antidiabetics therapy as judged by investigator
Exclusion criteria
* Patients with type 1 diabetes * Hypersensitivity to Levemir® or to any of the excipients * Pregnancy, or desire of pregnancy within next 6 months * HbA1c greater than or equal to 9% * Known or suspected allergy to the trial product or to any of the excipients * Subjects who are unlikely to comply with protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia. | During study |
Secondary
| Measure | Time frame |
|---|---|
| HbA1c | after 12 weeks (3 months) AND after 24 weeks (6 months) |
| FBG (Fasting Blood Glucose) | Monthly average for each month, and average of the past quarter |
| Weight | after 12 weeks (3 months) AND after 24 weeks (6 months) |
Countries
Algeria
Outcome results
None listed