DiabetesEVIDENCENCT01226966
Observational Study on Efficacy and Safety of Liraglutide in Subjects With Type 2 Diabetes
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Diabetes Mellitus, Type 2
- What is being tested?
- liraglutide
- How many people
- 3,152 participants
- Where
- 1 siteFrance
- Study dates
- Sep 2010to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients starting or having recently started liraglutide treatment for less than one week, and satisfying the study inclusion and exclusion criteria.
Who may be able to join
- Patients diagnosed with type 2 diabetes
- Patients having recently started (for less than one week) or starting liraglutide (Victoza®) treatment
Who cannot join
- Hypersensitivity (allergy) to liraglutide or to any of the excipients
- Patient is participating in a clinical trial at the inclusion
- Type 1 diabetes
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Being tested
- liraglutide
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
liraglutideDrug
Prescription is done at the discretion of the prescribing physician as part of normal clinical routine.
| Study group | Role | What they receive |
|---|---|---|
| A | Not described Receives: Drug: liraglutide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients still in liraglutide treatment and having a HbA1c (glycosylated haemoglobin) value below 7.0%
Measured: Month 24
Secondary outcomes (15)
Change in HbA1c at month 3
Measured: Month 0, Month 3
Change in HbA1c at month 6
Measured: Month 0, Month 6
Change in HbA1c at month 12
Measured: Month 0, Month 12
Change in HbA1c at month 18
Measured: Month 0, Month 18
Change in HbA1c at month 24
Measured: Month 0, Month 24
Change in fasting plasma glucose (FPG) at month 3
Measured: Month 0, Month 3
Change in fasting plasma glucose (FPG) at month 6
Measured: Month 0, Month 6
Change in fasting plasma glucose (FPG) at month 12
Measured: Month 0, Month 12
Change in fasting plasma glucose (FPG) at month 18
Measured: Month 0, Month 18
Change in fasting plasma glucose (FPG) at month 24
Measured: Month 0, Month 24
Change in Body Weight at Month 3
Measured: Month 0, Month 3
Change in Body Weight at Month 6
Measured: Month 0, Month 6
Change in Body Weight at Month 12
Measured: Month 0, Month 12
Change in Body Weight at Month 18
Measured: Month 0, Month 18
Change in Body Weight at Month 24
Measured: Month 0, Month 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- More trials run by Novo Nordisk A/SThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,152 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novo Nordisk A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Global Clinical Registry (GCR, 1452), Medical Advisor, Study director, Novo Nordisk A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01226966
- Sponsor's protocol ID
- NN2211-3815
- Other IDs
- U1111-1116-2722
- Acronym
- EVIDENCE
- Status last verified
- Feb 2017
- First submitted
- 20 Oct 2010
- Last updated
- 13 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26424330Martinez 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.
PubMed 28138803
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01226966
- Acronym / sponsor ID
- EVIDENCE / NN2211-3815
- Conditions
- Diabetes, Diabetes Mellitus, Type 2
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3,152 participants (actual)
- Lead sponsor
- Novo Nordisk A/SIndustry (pharma, biotech, devices)
- Study start
- Sep 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 22 Oct 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | Drug: liraglutide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients starting or having recently started liraglutide treatment for less than one week, and satisfying the study inclusion and exclusion criteria.
Key inclusion criteria (2 listed)
- Patients diagnosed with type 2 diabetes
- Patients having recently started (for less than one week) or starting liraglutide (Victoza®) treatment
Key exclusion criteria (3 listed)
- Hypersensitivity (allergy) to liraglutide or to any of the excipients
- Patient is participating in a clinical trial at the inclusion
- Type 1 diabetes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| liraglutidePrescription is done at the discretion of the prescribing physician as part of normal clinical routine. | Drug | A |
Primary outcome
Percentage of patients still in liraglutide treatment and having a HbA1c (glycosylated haemoglobin) value below 7.0%
Time frame: Month 24
15 secondary outcomes
Change in HbA1c at month 3
Time frame: Month 0, Month 3
Change in HbA1c at month 6
Time frame: Month 0, Month 6
Change in HbA1c at month 12
Time frame: Month 0, Month 12
Change in HbA1c at month 18
Time frame: Month 0, Month 18
Change in HbA1c at month 24
Time frame: Month 0, Month 24
Change in fasting plasma glucose (FPG) at month 3
Time frame: Month 0, Month 3
Change in fasting plasma glucose (FPG) at month 6
Time frame: Month 0, Month 6
Change in fasting plasma glucose (FPG) at month 12
Time frame: Month 0, Month 12
Change in fasting plasma glucose (FPG) at month 18
Time frame: Month 0, Month 18
Change in fasting plasma glucose (FPG) at month 24
Time frame: Month 0, Month 24
Change in Body Weight at Month 3
Time frame: Month 0, Month 3
Change in Body Weight at Month 6
Time frame: Month 0, Month 6
Change in Body Weight at Month 12
Time frame: Month 0, Month 12
Change in Body Weight at Month 18
Time frame: Month 0, Month 18
Change in Body Weight at Month 24
Time frame: Month 0, Month 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2017.
- Results publication: PubMed 26424330Gautier 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.
- Results publication: PubMed 28138803Martinez 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.
- Clinical Trials at Novo NordiskLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Global Clinical Registry (GCR, 1452), Medical Advisor study director
Novo Nordisk A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes and Diabetes Mellitus, Type 2, run by Novo Nordisk A/S at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients still in liraglutide treatment and having a HbA1c (glycosylated haemoglobin) value below 7.0% (time frame: Month 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01226966, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2017.