Clinical trial NCT01226966: Observational Study on Efficacy and Safety of Liraglutide in Subjects With Type 2 Diabetes
Official title: Conditions for Prescribing Liraglutide in Medical Practice and Assessment of Maintenance Level, Tolerability, and Efficacy of Victoza® (Liraglutide) in Subjects With Type 2 Diabetes
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Diabetes
Diabetes Mellitus, Type 2
Lead sponsor: Novo Nordisk A/S
Sponsor class: INDUSTRY
First posted: 2010-10-22
Enrollment: 3152
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* Hypersensitivity (allergy) to liraglutide or to any of the excipients
* Patient is participating in a clinical trial at the inclusion
* Type 1 diabetes

Primary outcomes:
measure: Percentage of patients still in liraglutide treatment and having a HbA1c (glycosylated haemoglobin) value below 7.0%
timeFrame: Month 24
Secondary outcomes:
measure: Change in HbA1c at month 3
timeFrame: Month 0, Month 3
measure: Change in HbA1c at month 6
timeFrame: Month 0, Month 6
measure: Change in HbA1c at month 12
timeFrame: Month 0, Month 12
measure: Change in HbA1c at month 18
timeFrame: Month 0, Month 18
measure: Change in HbA1c at month 24
timeFrame: Month 0, Month 24
measure: Change in fasting plasma glucose (FPG) at month 3
timeFrame: Month 0, Month 3
measure: Change in fasting plasma glucose (FPG) at month 6
timeFrame: Month 0, Month 6
measure: Change in fasting plasma glucose (FPG) at month 12
timeFrame: Month 0, Month 12
measure: Change in fasting plasma glucose (FPG) at month 18
timeFrame: Month 0, Month 18
measure: Change in fasting plasma glucose (FPG) at month 24
timeFrame: Month 0, Month 24
measure: Change in Body Weight at Month 3
timeFrame: Month 0, Month 3
measure: Change in Body Weight at Month 6
timeFrame: Month 0, Month 6
measure: Change in Body Weight at Month 12
timeFrame: Month 0, Month 12
measure: Change in Body Weight at Month 18
timeFrame: Month 0, Month 18
measure: Change in Body Weight at Month 24
timeFrame: Month 0, Month 24
Other outcomes:
Locations:
city: Paris La défense cedex
country: France
facility: Novo Nordisk Investigational Site
Study officials:
affiliation: Novo Nordisk A/S
name: Global Clinical Registry (GCR, 1452), Medical Advisor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.