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Trial · Observational

CompletedPhase not statedRegistry data

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

Short name ROOTS

NCTNCT01288326 (opens ClinicalTrials.gov in a new tab)Other idNN2211-3876Other idU1111-1116-2199
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
254 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Not stated
Countries
1 country

Belgium

Start
Feb 2011
Primary completion
Mar 2013
Completion
Mar 2013
First posted
2 Feb 2011 (estimated)
Last update posted
26 Jan 2017 (estimated)
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2011201220132014
  1. Ph –

    ROOTS

    NCT01288326

    Feb 2011 to Mar 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

  • liraglutideDrug

Arms1

  • Other

    A

Primary outcomes2

Outcomes the sponsor listed as primary.

  1. Percentage of participants with a decrease in HbA1c (glycosylated haemoglobin A1c) of at least 1%

    Time frame · month 12

  2. Percentage of participants reaching the treatment target of a HbA1c (glycosylated haemoglobin A1c) decrease of at least 1%

    Time frame · month 12

Secondary outcomes(5)

  1. HbA1c

    Time frame · month 12

  2. Fasting blood glucose (FBG)

    Time frame · month 12

  3. Incidence of serious adverse events (SAEs)

    Time frame · months 0-12

  4. Incidence of adverse drug reactions (ADRs)

    Time frame · months 0-12

  5. Frequency of hypoglycaemic episodes (frequency of episodes with low blood sugar)

    Time frame · months 0-12

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Observational study · 2015

8 results

ROOTS: A multicenter study in Belgium to evaluate the effectiveness and safety of liraglutide (Victoza®) in type 2 diabetic patients.

Buysschaert et al. 2015Diabetes & metabolic syndromecited by 18

PMID 26004030DOI 10.1016/j.dsx.2015.05.001PUB-26004030

Full text at the publisher8 results
Publisher pageSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
Not stated
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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