Observational Study in Type 2 Diabetics Failing on Oral Antidiabetic Therapy and Starting on Insulin Treatment
- Registration Number
- NCT00865397
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
This study is conducted in Europe. The aim of this observational study is to evaluate glycaemic control in subjects with type 2 diabetes using once daily Levemir® as initiation of insulin therapy in Hungary.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1032
Inclusion Criteria
- Patient with type 2 diabetes inadequately controlled by OAD therapy based on the discretion of individual physician
- Patient willing to sign informed consent
- Particular attention should be paid to age limits, indications and contraindications and the drug interactions that are listed within the product labels
Exclusion Criteria
- Subjects with diagnosed type 1 diabetes mellitus
- Subjects who are unlikely to comply with observational plan, (e.g., uncooperative attitude, inability to return for further visits)
- Subjects with hypersensitivity to Levemir® or to any of the ingredients
- Women of childbearing potential, who are pregnant, breast-feeding or intend to become pregnant within next 12 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 HbA1c after 24 weeks
- Secondary Outcome Measures
Name Time Method Change in body weight after 12 weeks and 24 weeks Change in waist and hip circumference after 12 weeks and 24 weeks Percentage of subjects to reach HbA1c below 7.0% and equal to or more than 6.5% after 12 weeks and 24 weeks Change in FPG (Fasting Plasma Glucose) after 12 weeks and 24 weeks
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇭🇺Budapest, Hungary