NCT02255266

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,788

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2015

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 30, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 2, 2014

Completed
6 months until next milestone

Study Start

First participant enrolled

March 26, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 16, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 16, 2015

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

8 months

First QC Date

September 30, 2014

Last Update Submit

April 16, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Frequency of patients achieving HbA1c reduction of at least 1%-point

    Week 0, week 52

Secondary Outcomes (8)

  • Change in HbA1c (Glycosylated haemoglobin))

    Week 0, week 104

  • Change in body weight

    Week 0, week 104

  • Frequency of patients achieving HbA1c reduction of at least 1%-point

    After 4 and 24 months of treatment

  • Frequency of patients achieving HbA1c target (<=7%)

    After 4, 12 and 24 months

  • Frequency of patients achieving a body weight reduction of at least 3%

    After 4, 12 and 24 months

  • +3 more secondary outcomes

Study Arms (1)

A

Drug: liraglutide

Interventions

No treatment given.

A

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All consecutive subjects initiating liraglutide in 2011 according to Victoza® SmPC meeting the inclusion criteria will be enrolled.

You may qualify if:

  • 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

You may not qualify if:

  • None. Available data from all eligible patients for each center, will be included

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Novo Nordisk Investigational Site

Rome, 00144, Italy

Location

Related 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 Diabetes in a Real-Life Setting: A 24-Month, Multicenter, Non-interventional, Retrospective Study. Adv Ther. 2018 Feb;35(2):243-253. doi: 10.1007/s12325-017-0652-2. Epub 2017 Dec 21.

Related Links

MeSH Terms

Conditions

Diabetes MellitusDiabetes Mellitus, Type 2

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1Glucagon-Like PeptidesProglucagonGastrointestinal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Global Clinical Registry (GCR, 1452)

    Novo Nordisk A/S

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 30, 2014

First Posted

October 2, 2014

Study Start

March 26, 2015

Primary Completion

November 16, 2015

Study Completion

November 16, 2015

Last Updated

April 17, 2018

Record last verified: 2018-04

Locations