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

NCT01226966 | Completed

• 2 other identifiers: NN2211-3815U1111-1116-2722
• Study Type: observational
• Target: 3,152
• Locations: 1 country
• Sites: 1

Brief Summary

This observational study is conducted in Europe. The aim of this non-interventional (observational) study is to evaluate the efficacy of liraglutide (Victoza®) and to assess the conditions of use of Victoza® in daily medical practice in France.

Conditions

Diabetes; Diabetes Mellitus, Type 2

Outcome Measures

Primary Outcomes (1)

• Percentage of patients still in liraglutide treatment and having a HbA1c (glycosylated haemoglobin) value below 7.0%

  Month 24

Secondary Outcomes (15)

• Change in HbA1c at month 3

  Month 0, Month 3

• Change in HbA1c at month 6

  Month 0, Month 6

• Change in HbA1c at month 12

  Month 0, Month 12

• Change in HbA1c at month 18

  Month 0, Month 18

• Change in HbA1c at month 24

  Month 0, Month 24

Study Arms (1)

A

Drug: liraglutide

Interventions

liraglutide DRUG

Prescription is done at the discretion of the prescribing physician as part of normal clinical routine.

A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients starting or having recently started liraglutide treatment for less than one week, and satisfying the study inclusion and exclusion criteria.

You may qualify if:

• Patients diagnosed with type 2 diabetes
• Patients having recently started (for less than one week) or starting liraglutide (Victoza®) treatment

You may not qualify if:

• Hypersensitivity (allergy) to liraglutide or to any of the excipients
• Type 1 diabetes

Sponsors & Collaborators

• Novo Nordisk A/S: lead

Study Sites (1)

Novo Nordisk Investigational Site

Paris La Défense Cedex, 92932, France

Location

Related Publications (2)

• Gautier JF, Martinez L, Penfornis A, Eschwege E, Charpentier G, Huret B, Madani S, Gourdy P. Effectiveness and Persistence with Liraglutide Among Patients with Type 2 Diabetes in Routine Clinical Practice--EVIDENCE: A Prospective, 2-Year Follow-Up, Observational, Post-Marketing Study. Adv Ther. 2015 Sep;32(9):838-53. doi: 10.1007/s12325-015-0245-x. Epub 2015 Sep 30.

  PMID: 26424330 RESULT

• Martinez L, Penfornis A, Gautier JF, Eschwege E, Charpentier G, Bouzidi A, Gourdy P. Effectiveness and Persistence of Liraglutide Treatment Among Patients with Type 2 Diabetes Treated in Primary Care and Specialist Settings: A Subgroup Analysis from the EVIDENCE Study, a Prospective, 2-Year Follow-up, Observational, Post-Marketing Study. Adv Ther. 2017 Mar;34(3):674-685. doi: 10.1007/s12325-017-0476-0. Epub 2017 Jan 30.

  PMID: 28138803 RESULT

Related Links

• Clinical Trials at Novo Nordisk

MeSH Terms

Conditions

Diabetes Mellitus; Diabetes Mellitus, Type 2

Interventions

Liraglutide

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

• Global Clinical Registry (GCR, 1452), Medical Advisor

  Novo Nordisk A/S

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 20, 2010
• First Posted: October 22, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2013
• Study Completion: November 1, 2013
• Last Updated: February 13, 2017

Record last verified: 2017-02

Locations

FR (1)