Type 2 DiabetesPhase 4GLP1 et GoûtNCT02674893
Effect of Victoza on Dietary Preferences and Habit in Patients With Type 2 Diabetes
A Phase 4 study testing Liraglutide and Observation alone in people with Type 2 Diabetes and Overweight, run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
This is an open-label comparative study in three parallel groups. It is expected that 90 patients and/or healthy volunteers will participate in this biomedical research. Distribution in groups 30 patients with type 2 diabetes and an indication for treatment with a GLP1 analogue (group 1) 30 patients with type 2… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Type 2 Diabetes, Overweight
- What is being tested?
- Liraglutide and Observation alone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteFrance
- Study dates
- 4 Feb 2014to 31 Aug 2016
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- DIABETIC PATIENTS TREATED WITH LIRAGLUTIDE
- persons who have provided written informed consent
- aged > 18 years
- type 2 diabetes with HbA1C > 7%
- overweight (BMI > 27)
- normal renal function (creatinine clearance > 50ml/min)
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- patients to be treated with Liraglutide (patients with type 2 diabetes with HbA1C > 7.5% and overweight or obesity, whose current treatment is insufficient to control the diabetes).
- CONTROL DIABETIC PATIENTS
- persons who have provided written informed consent
- aged > 18 years
- type 2 diabetes with HbA1C > 7%
- overweight (BMI > 27)
- patients for whom treatment with Liraglutide is not indicated
- normal renal function (creatinine clearance > 50ml/min)
- HEALTHY SUBJECTS
- persons who have provided written informed consent
- aged > 18 years
Who cannot join
- DIABETIC PATIENTS TREATED WITH LIRAGLUTIDE
- type 1 diabetes
- decompensated congestive heart failure
- acute or chronic infection, progressive cancer, liver cirrhosis
- ongoing treatment with antibiotics
- smoking
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- chronic alcohol abuse (>4 glasses a day)
- aversion to the products to be eaten or smelled
- poor understanding of the cognitive tasks requested
- treatment interfering with olfactogustatory performance, such as psychotropic, anti-emetic and anti-ulcer drugs
- persons without national health insurance cover
- persons under guardianship
- hypersensitivity to Liraglutide
- pregnancy, breastfeeding
- history of acute or chronic pancreatitis
- calcitonin level at selection ≥ 50 ng/L
- liver disease, defined by a level of alanine aminotransferase (ALAT) ≥ 2.5 times the upper limit of normal (ULN) for reference values
- CONTROL DIABETIC PATIENTS
- type 1 diabetes,
- decompensated congestive heart failure,
- acute or chronic infection, progressive cancer, liver cirrhosis,
- ongoing treatment with antibiotics,
- smoking
- chronic alcohol abuse (> 4 glasses a day),
- aversion to the products to be eaten or smelled,
- poor understanding of the cognitive tasks requested,
- treatment interfering with olfactogustatory performance, such as psychotropic, anti-emetic and anti-ulcer drugs.
- persons without national health insurance cover
- persons under guardianship
- HEALTHY SUBJECTS
- diabetes (type I and II)
- sensory disorders
- decompensated congestive heart failure,
- acute or chronic infection, progressive cancer, liver cirrhosis,
- ongoing treatment with antibiotics,
- smoking
- chronic alcohol abuse (> 4 glasses a day),
- aversion to the products to be eaten or smelled,
- poor understanding of the cognitive tasks requested,
- treatment interfering with olfactogustatory performance (psychotropic, anti-emetic, anti-ulcer drugs)
- persons without national health insurance cover
- persons under guardianship
- contra-indications to MRI, notably, but not limited to: pace maker, implantable cardiac defibrillators, neurostimulators, cochlear implants, certain implanted automated injection systems (insulin pumps), vascular intracerebral ferromagnetic clips, certain systems to regulate intravascular temperature, myopia requiring the patients to wear spectacle, history of stroke or transient ischemic attack (TIA), metallic foreign body, in particular intraocular or situated near high-risk zones (nervous system, vascular system), claustrophobia….
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparative Study of Gustatory Performance, Sensory Specific Satiation, Liking and Wanting in Patients With Type 2 Diabetes
This is an open-label comparative study in three parallel groups. It is expected that 90 patients and/or healthy volunteers will participate in this biomedical research.
Distribution in groups
Read more
- 30 patients with type 2 diabetes and an indication for treatment with a GLP1 analogue (group 1)
- 30 patients with type 2 diabetes (control diabetic subjects) not treated with Incretins (group 2)
- 30 healthy subjects (non-diabetics) (group 3)
This study will investigate modifications in eating behaviour induced by Liraglutide in patients who start treatment with Victoza® and certain aspects, such as liking (hedonic characteristic of a food), wanting (desire to eat a given food) and salivation in response to the presentation of a food by taking measurements at D0 (before initiation of the treatment with Liraglutide in the group concerned) then at 15 days (except for the controls), 3 months and 9 months (only for controls).
- Conditions
- Type 2 Diabetes, Overweight
- Being tested
- Liraglutide, Observation alone
- Keywords
- BMI>27, Treatment with Liraglutide
- Medical subject headings
- Diabetes Mellitus, Type 2, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LiraglutideDrug
Observation aloneOther
| Study group | Role | What they receive |
|---|---|---|
| type 2 diabetics treated with GLP1 analogue | Experimental | Not described Receives: Drug: Liraglutide |
| Type 2 diabetics not treated with incretins | Active comparator | Not described Receives: Other: Observation alone |
| Healthy subjects | Other | Not described Receives: Other: Observation alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Modifications in wanting
Measured: Up to 3 months
Secondary outcomes (5)
Modifications in gustatory performance
Measured: Until 3 months
Modifications in liking
Measured: Until 3 months
Modifications in salivation following the presentation of foods
Measured: Until 3 months
Modifications in optimal preferences for sweet and fatty tastes
Measured: Until 3 months
Anthropometric modifications
Measured: Until 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2016 (estimated)
- Study start4 Feb 2014
- Primary completion31 Aug 2016
- Study completion31 Aug 2016
Why it stopped: Exploratory protocol, convincing results, robust analysis
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- Interventional
- Phase
- Phase 4
- Intervention model
- Parallel groups
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02674893
- Sponsor's protocol ID
- BRINDISI 2013
- Acronym
- GLP1 et Goût
- Status last verified
- Feb 2026
- First submitted
- 2 Feb 2016
- Last updated
- 9 Feb 2026
- Results posted
- No
Publications
Brindisi MC, Brondel L, Meillon S, Barthet S, Grall S, Fenech C, Lienard F, Schlich P, Astruc K, Mouillot T, Jacquin-Piques A, Leloup C, Verges B, Penicaud L. Proof of concept: Effect of GLP-1 agonist on food hedonic responses and taste sensitivity in poor controlled type 2 diabetic patients. Diabetes Metab Syndr. 2019 Jul-Aug;13(4):2489-2494. doi: 10.1016/j.dsx.2019.06.021. Epub 2019 Jun 29.
PubMed 31405666
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of Gustatory Performance, Sensory Specific Satiation, Liking and Wanting in Patients With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02674893
- Acronym / sponsor ID
- GLP1 et Goût / BRINDISI 2013
- Conditions
- Type 2 Diabetes, Overweight
- Keywords
- BMI>27, Treatment with Liraglutide
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Exploratory protocol, convincing results, robust analysis
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 4 Feb 2014 (actual)
- Primary completion
- 31 Aug 2016 (actual)
- Study completion
- 31 Aug 2016 (actual)
- First posted
- 5 Feb 2016 (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 is an open-label comparative study in three parallel groups. It is expected that 90 patients and/or healthy volunteers will participate in this biomedical research.
Distribution in groups
- 30 patients with type 2 diabetes and an indication for treatment with a GLP1 analogue (group 1)
- 30 patients with type 2 diabetes (control diabetic subjects) not treated with Incretins (group 2)
- 30 healthy subjects (non-diabetics) (group 3)
This study will investigate modifications in eating behaviour induced by Liraglutide in patients who start treatment with Victoza® and certain aspects, such as liking (hedonic characteristic of a food), wanting (desire to eat a given food) and salivation in response to the presentation of a food by taking measurements at D0 (before initiation of the treatment with Liraglutide in the group concerned) then at 15 days (except for the controls), 3 months and 9 months (only for controls).
Study design
- Intervention model
- Parallel groups
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| type 2 diabetics treated with GLP1 analogue | Experimental | Drug: Liraglutide |
| Type 2 diabetics not treated with incretins | Active comparator | Other: Observation alone |
| Healthy subjects | Other | Other: Observation alone |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- DIABETIC PATIENTS TREATED WITH LIRAGLUTIDE
- persons who have provided written informed consent
- aged > 18 years
- type 2 diabetes with HbA1C > 7%
- overweight (BMI > 27)
Key exclusion criteria (43 listed)
- DIABETIC PATIENTS TREATED WITH LIRAGLUTIDE
- type 1 diabetes
- decompensated congestive heart failure
- acute or chronic infection, progressive cancer, liver cirrhosis
- ongoing treatment with antibiotics
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 |
|---|---|---|
| Liraglutide | Drug | type 2 diabetics treated with GLP1 analogue |
| Observation alone | Other | Healthy subjects, Type 2 diabetics not treated with incretins |
Primary outcome
Modifications in wanting
Time frame: Up to 3 months
5 secondary outcomes
Modifications in gustatory performance
Time frame: Until 3 months
Modifications in liking
Time frame: Until 3 months
Modifications in salivation following the presentation of foods
Time frame: Until 3 months
Modifications in optimal preferences for sweet and fatty tastes
Time frame: Until 3 months
Anthropometric modifications
Time frame: Until 3 months
Results and safety
The study was stopped early (reason given: Exploratory protocol, convincing results, robust analysis). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2026.
- Results publication: PubMed 31405666Brindisi MC, Brondel L, Meillon S, Barthet S, Grall S, Fenech C, Lienard F, Schlich P, Astruc K, Mouillot T, Jacquin-Piques A, Leloup C, Verges B, Penicaud L. Proof of concept: Effect of GLP-1 agonist on food hedonic responses and taste sensitivity in poor controlled type 2 diabetic patients. Diabetes Metab Syndr. 2019 Jul-Aug;13(4):2489-2494. doi: 10.1016/j.dsx.2019.06.021. Epub 2019 Jun 29.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Liraglutide and Observation alone in people with Type 2 Diabetes and Overweight, run by Centre Hospitalier Universitaire Dijon 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 17 inclusion and 43 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: stopped early, as of the sponsor's last update on 9 Feb 2026. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Exploratory protocol, convincing results, robust analysis). Results are not available in the source record.
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?
Modifications in wanting (time frame: Up to 3 months). 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 NCT02674893, which also lists 1 linked publication.
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 9 Feb 2026.