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NCT01288326 Clinical Trial

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

Diabetes Mellitus, Type 2 Clinical Trial

— ROOTS  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01288326
Other study ID # NN2211-3876
Secondary ID U1111-1116-2199
Status Completed
Phase N/A
First received January 28, 2011
Last updated January 25, 2017
Start date February 2011
Est. completion date March 2013

Study information
Verified date January 2017
Source Novo Nordisk A/S
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 254
Est. completion date March 2013
Est. primary completion date March 2013
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• liraglutide
Liraglutide will be prescribed and titrated (individually adjusted) by the treating physician.

Locations
Country Name City State
Belgium Novo Nordisk Investigational Site Brussels

Sponsors (1)
Lead Sponsor Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

Belgium, 

References & 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®) in type 2 diabetic patients. Diabetes Metab Syndr. 2015 Jul-Sep;9(3):139-42. doi: 10.1016/j. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of participants with a decrease in HbA1c (glycosylated haemoglobin A1c) of at least 1% month 12
Primary Percentage of participants reaching the treatment target of a HbA1c (glycosylated haemoglobin A1c) decrease of at least 1% month 12
Secondary HbA1c month 12
Secondary Fasting blood glucose (FBG) month 12
Secondary Incidence of serious adverse events (SAEs) months 0-12
Secondary Incidence of adverse drug reactions (ADRs) months 0-12
Secondary Frequency of hypoglycaemic episodes (frequency of episodes with low blood sugar) months 0-12
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