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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT01288326
First received: January 28, 2011
Last updated: August 25, 2014
Last verified: August 2014
  Purpose

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 Intervention
Diabetes
Diabetes Mellitus, Type 2
Drug: liraglutide

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Novo Nordisk A/S:

Primary Outcome Measures:
  • Percentage of participants with a decrease in HbA1c (glycosylated haemoglobin A1c) of at least 1% [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Percentage of participants reaching the treatment target of a HbA1c (glycosylated haemoglobin A1c) decrease of at least 1% [ Time Frame: month 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • HbA1c [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Fasting blood glucose (FBG) [ Time Frame: month 12 ] [ Designated as safety issue: No ]
  • Incidence of serious adverse events (SAEs) [ Time Frame: months 0-12 ] [ Designated as safety issue: No ]
  • Incidence of adverse drug reactions (ADRs) [ Time Frame: months 0-12 ] [ Designated as safety issue: No ]
  • Frequency of hypoglycaemic episodes (frequency of episodes with low blood sugar) [ Time Frame: months 0-12 ] [ Designated as safety issue: No ]

Enrollment: 254
Study Start Date: February 2011
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A Drug: liraglutide
Liraglutide will be prescribed and titrated (individually adjusted) by the treating physician.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01288326

Locations
Belgium
Brussels, Belgium, 1070
Sponsors and Collaborators
Novo Nordisk A/S
Investigators
Study Director: Global Clinical Registry (GCR, 1452) Novo Nordisk A/S
  More Information

Additional Information:
No publications provided

Responsible Party: Novo Nordisk A/S
ClinicalTrials.gov Identifier: NCT01288326     History of Changes
Other Study ID Numbers: NN2211-3876, U1111-1116-2199
Study First Received: January 28, 2011
Last Updated: August 25, 2014
Health Authority: Belgium: Federal Agency for Medicines and Health Products, FAMHP

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

ClinicalTrials.gov processed this record on November 25, 2014