Observational Study on Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes
- Registration Number
- NCT01288326
- Lead Sponsor
- Novo Nordisk A/S
- Brief Summary
The study is conducted in Europe. The aim of this observational study is to assess glycaemic control while using liraglutide under normal clinical practice conditions in Belgium.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 254
Inclusion Criteria
- Type 2 diabetes
- Insufficiently controlled after 3 months of treatment with OADs (oral anti-diabetic drugs)
Exclusion Criteria
- Previously treated with liraglutide
- Hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections)
- Pregnant, breast feeding or have the intention of becoming pregnant
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description A liraglutide -
- Primary Outcome Measures
Name Time Method Percentage of participants with a decrease in HbA1c (glycosylated haemoglobin A1c) of at least 1% month 12 Percentage of participants reaching the treatment target of a HbA1c (glycosylated haemoglobin A1c) decrease of at least 1% month 12
- Secondary Outcome Measures
Name Time Method Incidence of adverse drug reactions (ADRs) months 0-12 Fasting blood glucose (FBG) month 12 Frequency of hypoglycaemic episodes (frequency of episodes with low blood sugar) months 0-12 HbA1c month 12 Incidence of serious adverse events (SAEs) months 0-12
Trial Locations
- Locations (1)
Novo Nordisk Investigational Site
🇧🇪Brussels, Belgium