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

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Novo Nordisk

ClinicalTrials.gov Identifier:

NCT01226966

First received: October 20, 2010

Last updated: April 19, 2013

Last verified: December 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

October 20, 2010

Last Updated Date

April 19, 2013

Start Date ^ICMJE

October 2010

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Percentage of patients still in liraglutide treatment and having a HbA1c (glycosylated haemoglobin) value below 7.0% [ Time Frame: Month 24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01226966 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change in HbA1c at month 3 [ Time Frame: Month 0, Month 3 ] [ Designated as safety issue: No ]
Change in HbA1c at month 6 [ Time Frame: Month 0, Month 6 ] [ Designated as safety issue: No ]
Change in HbA1c at month 12 [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
Change in HbA1c at month 18 [ Time Frame: Month 0, Month 18 ] [ Designated as safety issue: No ]
Change in HbA1c at month 24 [ Time Frame: Month 0, Month 24 ] [ Designated as safety issue: No ]
Change in fasting plasma glucose (FPG) at month 3 [ Time Frame: Month 0, Month 3 ] [ Designated as safety issue: No ]
Change in fasting plasma glucose (FPG) at month 6 [ Time Frame: Month 0, Month 6 ] [ Designated as safety issue: No ]
Change in fasting plasma glucose (FPG) at month 12 [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
Change in fasting plasma glucose (FPG) at month 18 [ Time Frame: Month 0, Month 18 ] [ Designated as safety issue: No ]
Change in fasting plasma glucose (FPG) at month 24 [ Time Frame: Month 0, Month 24 ] [ Designated as safety issue: No ]
Change in Body Weight at Month 3 [ Time Frame: Month 0, Month 3 ] [ Designated as safety issue: No ]
Change in Body Weight at Month 6 [ Time Frame: Month 0, Month 6 ] [ Designated as safety issue: No ]
Change in Body Weight at Month 12 [ Time Frame: Month 0, Month 12 ] [ Designated as safety issue: No ]
Change in Body Weight at Month 18 [ Time Frame: Month 0, Month 18 ] [ Designated as safety issue: No ]
Change in Body Weight at Month 24 [ Time Frame: Month 0, Month 24 ] [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Conditions for Prescribing Liraglutide in Medical Practice and Assessment of Maintenance Level, Tolerability, and Efficacy of Victoza® (Liraglutide) in Subjects With Type 2 Diabetes

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

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.

Condition ^ICMJE

Diabetes
Diabetes Mellitus, Type 2

Intervention ^ICMJE

Drug: liraglutide

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

Study Group/Cohort (s)

Intervention: Drug: liraglutide

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

2845

Estimated Completion Date

October 2013

Estimated Primary Completion Date

October 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

France

Administrative Information

NCT Number ^ICMJE

NCT01226966

Other Study ID Numbers ^ICMJE

NN2211-3815, U1111-1116-2722

Has Data Monitoring Committee

Responsible Party

Novo Nordisk

Study Sponsor ^ICMJE

Novo Nordisk

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

Hind Moumane, Medical Advisor

Novo Nordisk

Information Provided By

Novo Nordisk

Verification Date

December 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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