Observational Study on Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes
ROOTS
A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes Mellitus
2 other identifiers
observational
254
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2011
Typical duration for all trials
1 active site
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
January 28, 2011
CompletedStudy Start
First participant enrolled
February 1, 2011
CompletedFirst Posted
Study publicly available on registry
February 2, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2013
CompletedJanuary 26, 2017
January 1, 2017
2.1 years
January 28, 2011
January 25, 2017
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (5)
HbA1c
month 12
Fasting blood glucose (FBG)
month 12
Incidence of serious adverse events (SAEs)
months 0-12
Incidence of adverse drug reactions (ADRs)
months 0-12
Frequency of hypoglycaemic episodes (frequency of episodes with low blood sugar)
months 0-12
Study Arms (1)
A
Interventions
Liraglutide will be prescribed and titrated (individually adjusted) by the treating physician.
Eligibility Criteria
Subjects with type 2 diabetes mellitus for whom physicians determine that liraglutide is an appropriate new treatment.
You may qualify if:
- Type 2 diabetes
- Insufficiently controlled after 3 months of treatment with OADs (oral anti-diabetic drugs)
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Novo Nordisk A/Slead
Study Sites (1)
Novo Nordisk Investigational Site
Brussels, 1070, Belgium
Related Publications (1)
Buysschaert M, D'Hooge D, Preumont V; Roots Study Group. ROOTS: A multicenter study in Belgium to evaluate the effectiveness and safety of liraglutide (Victoza(R)) in type 2 diabetic patients. Diabetes Metab Syndr. 2015 Jul-Sep;9(3):139-42. doi: 10.1016/j.dsx.2015.05.001. Epub 2015 May 8.
PMID: 26004030RESULT
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Global Clinical Registry (GCR, 1452)
Novo Nordisk A/S
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2011
First Posted
February 2, 2011
Study Start
February 1, 2011
Primary Completion
March 1, 2013
Study Completion
March 1, 2013
Last Updated
January 26, 2017
Record last verified: 2017-01