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Trial · Observational

CompletedPhase not statedRegistry data

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

Short name EVIDENCE

NCTNCT01226966 (opens ClinicalTrials.gov in a new tab)Other idNN2211-3815Other idU1111-1116-2722
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase not stated
Enrollment
3,152 participants (actual)
Sponsor
Novo Nordisk A/S · Industry
Design
Not stated
Countries
1 country

France

Start
Sept 2010
Primary completion
Nov 2013
Completion
Nov 2013
First posted
22 Oct 2010 (estimated)
Last update posted
13 Feb 2017
Conditions
Diabetes · Diabetes Mellitus, Type 2

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
20102011201220132014
  1. Ph –

    EVIDENCE

    NCT01226966

    Sept 2010 to Nov 2013

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

  • liraglutideDrug

Arms1

  • Other

    A

Primary outcomes1

Outcomes the sponsor listed as primary.

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

    Time frame · Month 24

Secondary outcomes(15)

  1. Change in HbA1c at month 3

    Time frame · Month 0, Month 3

  2. Change in HbA1c at month 6

    Time frame · Month 0, Month 6

  3. Change in HbA1c at month 12

    Time frame · Month 0, Month 12

  4. Change in HbA1c at month 18

    Time frame · Month 0, Month 18

  5. Change in HbA1c at month 24

    Time frame · Month 0, Month 24

  6. Change in fasting plasma glucose (FPG) at month 3

    Time frame · Month 0, Month 3

  7. Change in fasting plasma glucose (FPG) at month 6

    Time frame · Month 0, Month 6

  8. Change in fasting plasma glucose (FPG) at month 12

    Time frame · Month 0, Month 12

  9. Change in fasting plasma glucose (FPG) at month 18

    Time frame · Month 0, Month 18

  10. Change in fasting plasma glucose (FPG) at month 24

    Time frame · Month 0, Month 24

  11. Change in Body Weight at Month 3

    Time frame · Month 0, Month 3

  12. Change in Body Weight at Month 6

    Time frame · Month 0, Month 6

  13. Change in Body Weight at Month 12

    Time frame · Month 0, Month 12

  14. Change in Body Weight at Month 18

    Time frame · Month 0, Month 18

  15. Change in Body Weight at Month 24

    Time frame · Month 0, Month 24

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies2

Studies that cite this trial.

Studies with results

2 studies on this page

Indexing hint: Observational study · 2017

10 results

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.

Martinez et al. 2017Advances in therapycited by 10

PMID 28138803PMC5350193DOI 10.1007/s12325-017-0476-0PUB-28138803

Free to read · publisher termsCC BY-NC10 results
Read at sourceSee results (10)

Indexing hint: Observational study · 2015

8 results

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.

Gautier et al. 2015Advances in therapycited by 29

PMID 26424330PMC4604502DOI 10.1007/s12325-015-0245-xPUB-26424330

Free to read · publisher termsCC BY-NC8 results
Read at sourceSee results (8)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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