Diabetes Mellitus, Type 2 Clinical Trial
Official title:
Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice
| Verified date | April 2018 |
| Source | Novo Nordisk A/S |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
This study is conducted in Europe. The aim of this study is to investigate Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in daily Practice.
| Status | Completed |
| Enrollment | 1788 |
| Est. completion date | November 16, 2015 |
| Est. primary completion date | November 16, 2015 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Subjects of age above 18 years as per Victoza® SmPC par.4.2 and 5.1 diagnosed with type 2 diabetes receiving the first prescription of liraglutide in 2011 Exclusion Criteria: - None. Available data from all eligible patients for each center, will be included |
| Country | Name | City | State |
|---|---|---|---|
| Italy | Novo Nordisk Investigational Site | Rome |
| Lead Sponsor | Collaborator |
|---|---|
| Novo Nordisk A/S |
Italy,
Lapolla A, Berra C, Boemi M, Bossi AC, Candido R, Di Cianni G, Frontoni S, Genovese S, Ponzani P, Provenzano V, Russo GT, Sciangula L, Simioni N, Bette C, Nicolucci A; NN2211-4118 Study Group. Long-Term Effectiveness of Liraglutide for Treatment of Type 2 — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Frequency of patients achieving HbA1c reduction of at least 1%-point | Week 0, week 52 | ||
| Secondary | Change in HbA1c (Glycosylated haemoglobin)) | Week 0, week 104 | ||
| Secondary | Change in body weight | Week 0, week 104 | ||
| Secondary | Frequency of patients achieving HbA1c reduction of at least 1%-point | After 4 and 24 months of treatment | ||
| Secondary | Frequency of patients achieving HbA1c target (<=7%) | After 4, 12 and 24 months | ||
| Secondary | Frequency of patients achieving a body weight reduction of at least 3% | After 4, 12 and 24 months | ||
| Secondary | Frequency of patients achieving the composite endpoint consisting in: HbA1c reduction of at least 1%-point and body weight reduction of at least 3% | After 4, 12 and 24 months | ||
| Secondary | Percentage of treatment discontinuation for any reason | At 4, 12 and 24 months | ||
| Secondary | Changes in blood pressure and lipid profile | Week 0, week 104 |
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