Observational Study on Efficacy and Safety of Liraglutide... | NCT01226966

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

NCT01226966

Sponsor

Novo Nordisk A/S

Status

Completed

Last Update Posted

Feb 13, 2017Actual

Enrollment

3,152Actual

Phase

Not provided

Conditions

Diabetes
Diabetes Mellitus, Type 2

Interventions

liraglutide

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
U1111-1116-2722	Other Identifier	WHO

Status Module

Record Verification Date

Feb 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2010

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Oct 20, 2010

First Submission Date that Met QC Criteria

Oct 21, 2010

First Posted Date

Oct 22, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 10, 2017

Last Update Posted Date

Feb 13, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,152Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
A			Drug: liraglutide

Interventions

Name	Type	Description	Arm Group Labels	Other Names
liraglutide	Drug	Prescription is done at the discretion of the prescribing physician as part of normal clinical routine.	A

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of patients still in liraglutide treatment and having a HbA1c (glycosylated haemoglobin) value below 7.0%		Month 24

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Global Clinical Registry (GCR, 1452), Medical Advisor	Novo Nordisk A/S	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Novo Nordisk Investigational Site		Paris La Défense Cedex		92932	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
26424330	Result	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.
28138803

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

ID	Term
D052216	Glucagon-Like Peptide 1
D004763	Glucagon-Like Peptides
D052336	Proglucagon
D005768	Gastrointestinal Hormones

ID	Term
D003920	Diabetes Mellitus
D003924	Diabetes Mellitus, Type 2