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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01288326
Recruitment Status : Completed
First Posted : February 2, 2011
Last Update Posted : January 26, 2017
Information provided by (Responsible Party):
Novo Nordisk A/S

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.

Condition or disease Intervention/treatment
Diabetes Diabetes Mellitus, Type 2 Drug: liraglutide

Study Type : Observational
Actual Enrollment : 254 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Study Start Date : February 2011
Actual Primary Completion Date : March 2013
Actual Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

Drug Information available for: Liraglutide
U.S. FDA Resources

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

Primary Outcome Measures :
  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 Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Subjects with type 2 diabetes mellitus for whom physicians determine that liraglutide is an appropriate new treatment.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01288326

Novo Nordisk Investigational Site
Brussels, Belgium, 1070
Sponsors and Collaborators
Novo Nordisk A/S
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S

Additional Information:
Publications of Results:
Responsible Party: Novo Nordisk A/S Identifier: NCT01288326     History of Changes
Other Study ID Numbers: NN2211-3876
U1111-1116-2199 ( Other Identifier: WHO )
First Posted: February 2, 2011    Key Record Dates
Last Update Posted: January 26, 2017
Last Verified: January 2017

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists