Observational Study of Glycaemic Control in Patients Uncontrolled on Oral Antidiabetic Agents and Starting With 1 (Once) Daily Levemir® (Insulin Detemir) as the Treatment of Type 2 Diabetes Mellitus
- Registration Number
- NCT00687284
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Europe. An observational study evaluating glycaemic control in patients using Levemir® as initiation insulin therapy as the treatment of type 2 diabetes in Slovakia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2188
Inclusion Criteria
- Patients with type 2 diabetes
- Patients inadequately controlled by OAD
- Patients willing to sign informed consent
- Selection of study participants at the discretion of the physician
- Particular attention should be paid to the drug interactions that are listed within the product label
Exclusion Criteria
- Subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit;
- Subjects who were previously enrolled in this study
- Subjects with a hypersensitivity to insulin detemir or to any of the excipients.
- Women who are pregnant, breastfeeding or have the intention of becoming pregnant within next 6 months
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A insulin detemir -
- Primary Outcome Measures
Name Time Method Change in glycaemic control as measured by HbA1c. For the duration of the study
- Secondary Outcome Measures
Name Time Method The effect on glycaemic control as measured by FPG After 12 weeks and 24 weeks Change in body weight After 12 weeks and 24 weeks Change in waist and hip perimeter After 12 weeks and 24 weeks Percentage of subjects to reach HbA1c below 7.0% and below or equal 6.5% After 12 weeks and 24 weeks
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇸🇰Kosice, Slovakia