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NCT02255266 Clinical Trial

Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice

Diabetes Mellitus, Type 2 Clinical Trial

Official title:
Long-Term Effectiveness of Liraglutide for Treatment of Type 2 Diabetes in Daily Practice

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02255266
Other study ID # NN2211-4118
Secondary ID U1111-1143-9842
Status Completed
Phase
First received September 30, 2014
Last updated April 16, 2018
Start date March 26, 2015
Est. completion date November 16, 2015

Study information
Verified date April 2018
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• liraglutide
No treatment given.

Locations
Country Name City State
Italy Novo Nordisk Investigational Site Rome

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Italy, 

References & Publications (1)

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

Outcome
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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