Clinical Trials Register

Summary
EudraCT Number:	2021-003880-88
Sponsor's Protocol Code Number:	BOUILLET_PHRCI_2020
National Competent Authority:	France - ANSM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-09-02
Trial results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

France - ANSM

A.2

EudraCT number

2021-003880-88

A.3

Full title of the trial

TOLEDDO: Effet d’un traitement par agoniste GLP1 hebdomadaire dans le « diabète double »

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Effet d'un traitement par agoniste GLP1 hebdomadaire dans le "diabète double"

A.4.1

Sponsor's protocol code number

BOUILLET_PHRCI_2020

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	CHU Dijon Bourgogne
B.1.3.4	Country	France
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	CHU Dijon Bourgogne
B.5.2	Functional name of contact point	Chef de projets recherche
B.5.3	Address:
B.5.3.1	Street Address	DRCI - 1, boulevard Jeanne d'Arc - BP 77908
B.5.3.2	Town/ city	Dijon
B.5.3.3	Post code	21079
B.5.3.4	Country	France
B.5.4	Telephone number	0380295578
B.5.6	E-mail	DRCIDijon.UPI@chu-dijon.fr

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Ozempic®
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVO NORDISK
D.2.1.2	Country which granted the Marketing Authorisation	France
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Diabète double

E.1.1.1

Medical condition in easily understood language

Diabète double

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Etudier, chez des patients ayant un diabète de type 1 avec un « diabète double », l’effet de 6 mois d’un traitement additionnel par sémaglutide sur l’évolution du pourcentage du temps passé dans la cible glycémique (0,70-1,80 g/l) entre t0 et t6mois comparativement au traitement standard.

E.2.2

Secondary objectives of the trial

Etudier, chez des patients ayant un diabète de type 1 avec un « diabète double », l’effet de 6 mois d’un traitement additionnel par sémaglutide comparativement au traitement standard sur
o HbA1c
o Le poids, le tour de taille
o La dose quotidienne d’insuline administrée
o La variabilité glycémique.
o La survenue d’hypoglycémies
o La survenue éventuelle d’effets indésirables

Etudier l’effet du traitement par sémaglutide entre J0 et J90, ainsi qu’entre J90 et J180 sur :
o L’évolution du pourcentage du temps passé dans la cible glycémique (0,70-1,80 g/l
o HbA1c
o Le poids, le tour de taille
o La dose quotidienne d’insuline administrée
o La variabilité glycémique.
o La survenue d’hypoglycémies

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Personne ayant donné son consentement écrit Patient âgé de plus de 18 ans
- Patient diabétique de type 1 confirmé par un C-peptide négatif
- Age de diagnostic < 35 ans
- Traité par insulinothérapie optimisée (multi-injections ou pompe) depuis au moins 1 an, ayant reçu une éducation thérapeutique spécifique à l’adaptation des doses d’insuline.
- BMI (Poids/taille2) ≥ 27 Kg/m²
- Au moins un critère parmi les suivants :
o Antécédents familiaux de diabète de type 2 (parents, grands-parents, oncles, tantes, frères et sœurs)
o Antécédents familiaux d’obésité (BMI>30 Kg/m2) (parents, grands-parents, oncles, tantes, frères et sœurs)
o Triglycérides > 1.50g/l (1.7mmol/l)
o HDL< 0.5 g/l (1.29 mmol/l) chez la femme, HDL<0.4 g/l (1.03 mmol/l) chez l’homme
- HbA1c ≥ 7.5% et < 12%
- Ayant une surveillance du glucose en continu par le système Free Style Libre
- Pour les femmes en âge de procréer sous contraception efficace jusqu’à 2 mois après la fin du traitement. La contraception efficace comprend : contraception hormonale, dispositif intra utérin, occlusion tubaire bilatérale, vasectomie et abstinence sexuelle

E.4

Principal exclusion criteria

- personne non affiliée à un régime de sécurité sociale
- Femme enceinte, parturiente ou allaitante
- HbA1c ≥12%
- Rétinopathie ou maculopathie diabétique non contrôlée et potentiellement instable, confirmée par un examen du fond d’œil réalisé dans les 6 mois précédant la sélection Personne faisant l’objet d’une mesure de protection légale (curatelle, tutelle)
- Personne faisant l’objet d’une mesure de sauvegarde de justice
- Insuffisance rénale (DFG<30 ml/mn)
- insuffisance hépatique (INR> 1,5)
- IMC> 40 kg/m²
- Antécédents de chirurgie bariatrique
- Antécédents de pancréatite
-Allergie à la substance active ou à l'un des excipients d’OZEMPIC®
- Patient recevant un traitement par agoniste GLP1 ou par antidiabétique oral

E.5 End points

E.5.1

Primary end point(s)

Pourcentage du temps passé dans la cible glycémique (0.70-1.80 g/l)

E.5.1.1

Timepoint(s) of evaluation of this end point

entre J0 et J180

E.5.2

Secondary end point(s)

- HbA1c
- Poids, le tour de taille
- dose totale quotidienne d’insuline administrée
- variabilité glycémique, évaluée sur les données de l’enregistrement du glucose en continue au moyen du capteur Free style Libre par l’Ecart-Type (SD) et le MAGE (Mean Amplitude of Glycemic Excursions)
- temps passé en glucose interstitiel < 0.7 g/l et <0.54 g/l (données du Free Style Libre)
- Pourcentage d’évènements indésirables dans les 2 groupes

E.5.2.1

Timepoint(s) of evaluation of this end point

entre t0 et t6 mois entre les 2 groupes entre t0 et t6 mois, entre t0 et 3 mois et entre t3 mois et t6 mois

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Traitement insuline habituel

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

F. Population of Trial Subjects

F.1 Age Range

F.1.1

Trial has subjects under 18

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.3

Elderly (>=65 years)

Yes

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

None

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2022-01-28

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-09-28

P. End of Trial
P.	End of Trial Status	Ongoing

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