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

January 25, 2017 updated by: Novo Nordisk A/S

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

254

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1070
        • Novo Nordisk Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects with type 2 diabetes mellitus for whom physicians determine that liraglutide is an appropriate new treatment.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Drug: liraglutide
Liraglutide will be prescribed and titrated (individually adjusted) by the treating physician.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Percentage of participants with a decrease in HbA1c (glycosylated haemoglobin A1c) of at least 1%
Time Frame: month 12
month 12
Percentage of participants reaching the treatment target of a HbA1c (glycosylated haemoglobin A1c) decrease of at least 1%
Time Frame: month 12
month 12

Secondary Outcome Measures

Outcome Measure
Time Frame
HbA1c
Time Frame: month 12
month 12
Fasting blood glucose (FBG)
Time Frame: month 12
month 12
Incidence of serious adverse events (SAEs)
Time Frame: months 0-12
months 0-12
Incidence of adverse drug reactions (ADRs)
Time Frame: months 0-12
months 0-12
Frequency of hypoglycaemic episodes (frequency of episodes with low blood sugar)
Time Frame: months 0-12
months 0-12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novo Nordisk A/S

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2011

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

March 1, 2013

Study Registration Dates

First Submitted

January 28, 2011

First Submitted That Met QC Criteria

February 1, 2011

First Posted (Estimate)

February 2, 2011

Study Record Updates

Last Update Posted (Estimate)

January 26, 2017

Last Update Submitted That Met QC Criteria

January 25, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NN2211-3876
  • U1111-1116-2199 (Other Identifier: WHO)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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