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

Diabetes Mellitus, Type 2 Clinical Trial

— EVIDENCE  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01226966
• Other study ID #: NN2211-3815
• Secondary ID: U1111-1116-2722
• Status: Completed
• Phase: N/A
• First received: October 20, 2010
• Last updated: February 10, 2017
• Start date: September 2010
• Est. completion date: November 2013

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3152
• Est. completion date: November 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Diabetes Mellitus, Type 2

Intervention

Drug:
• liraglutide
Prescription is done at the discretion of the prescribing physician as part of normal clinical routine.

Locations

Country	Name	City	State
France	Novo Nordisk Investigational Site	Paris La défense cedex

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Country where clinical trial is conducted

France, 

References & Publications (2)

Gautier JF, Martinez L, Penfornis A, Eschwège 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, Observ — View Citation

Martinez L, Penfornis A, Gautier JF, Eschwège 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 E — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients still in liraglutide treatment and having a HbA1c (glycosylated haemoglobin) value below 7.0%		Month 24
Secondary	Change in HbA1c at month 3		Month 0, Month 3
Secondary	Change in HbA1c at month 6		Month 0, Month 6
Secondary	Change in HbA1c at month 12		Month 0, Month 12
Secondary	Change in HbA1c at month 18		Month 0, Month 18
Secondary	Change in HbA1c at month 24		Month 0, Month 24
Secondary	Change in fasting plasma glucose (FPG) at month 3		Month 0, Month 3
Secondary	Change in fasting plasma glucose (FPG) at month 6		Month 0, Month 6
Secondary	Change in fasting plasma glucose (FPG) at month 12		Month 0, Month 12
Secondary	Change in fasting plasma glucose (FPG) at month 18		Month 0, Month 18
Secondary	Change in fasting plasma glucose (FPG) at month 24		Month 0, Month 24
Secondary	Change in Body Weight at Month 3		Month 0, Month 3
Secondary	Change in Body Weight at Month 6		Month 0, Month 6
Secondary	Change in Body Weight at Month 12		Month 0, Month 12
Secondary	Change in Body Weight at Month 18		Month 0, Month 18
Secondary	Change in Body Weight at Month 24		Month 0, Month 24

External Links

•   Clinical Trials at Novo Nordisk