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Observational Study on Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes

A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Effectiveness and Safety of Liraglutide in Subjects With Type 2 Diabetes Mellitus

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01288326
Acronym
ROOTS
Enrollment
254
Registered
2011-02-02
Start date
2011-02-28
Completion date
2013-03-31
Last updated
2017-01-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes, Diabetes Mellitus, Type 2

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.

Interventions

DRUGliraglutide

Liraglutide will be prescribed and titrated (individually adjusted) by the treating physician.

Sponsors

Novo Nordisk A/S
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Percentage of participants reaching the treatment target of a HbA1c (glycosylated haemoglobin A1c) decrease of at least 1%month 12
Percentage of participants with a decrease in HbA1c (glycosylated haemoglobin A1c) of at least 1%month 12

Secondary

MeasureTime frame
Incidence of serious adverse events (SAEs)months 0-12
HbA1cmonth 12
Frequency of hypoglycaemic episodes (frequency of episodes with low blood sugar)months 0-12
Incidence of adverse drug reactions (ADRs)months 0-12
Fasting blood glucose (FBG)month 12

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026