Effect of Victoza on Dietary Preferences and Habit in Patients With Type 2 Diabetes

NCT02674893 | Terminated Phase 4

• 1 other identifier: BRINDISI 2013
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief 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 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

Keywords

BMI>27; Treatment with Liraglutide

Outcome Measures

Primary Outcomes (1)

• Modifications in wanting

  Up to 3 months

Secondary Outcomes (5)

• Modifications in gustatory performance

  Until 3 months

• Modifications in liking

  Until 3 months

• Modifications in salivation following the presentation of foods

  Until 3 months

• Modifications in optimal preferences for sweet and fatty tastes

  Until 3 months

• Anthropometric modifications

  Until 3 months

Study Arms (3)

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

Interventions

Liraglutide DRUG

type 2 diabetics treated with GLP1 analogue

Observation alone OTHER

Healthy subjects; Type 2 diabetics not treated with incretins

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)
• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire Dijon: lead

Study Sites (1)

CHU de DIJON

Dijon, 21079, France

Location

Related Publications (1)

• 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.

  PMID: 31405666 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Overweight

Interventions

Liraglutide; Observation

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Glucagon-Like Peptide 1; Glucagon-Like Peptides; Proglucagon; Gastrointestinal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Methods; Investigative Techniques

Study Design

• Study Type: interventional
• Phase: phase 4
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 2, 2016
• First Posted: February 5, 2016
• Study Start: February 4, 2014
• Primary Completion: August 31, 2016
• Study Completion: August 31, 2016
• Last Updated: February 9, 2026

Record last verified: 2026-02

Locations

FR (1)