Observational Study to Evaluate the Safety and Efficacy of Levemir® in Type 2 Diabetes
- Registration Number
- NCT00700830
- Lead Sponsor
- Novo Nordisk A/S
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1976
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A insulin detemir -
- Primary Outcome Measures
Name Time Method Assessment the incidence of the Serious Adverse Events including the major Hypoglycaemia. During study
- Secondary Outcome Measures
Name Time Method 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) HbA1c after 12 weeks (3 months) AND after 24 weeks (6 months)