Clinical Trials Register

Summary
EudraCT Number:	2019-002977-69
Sponsor's Protocol Code Number:	BEYOND
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2021-05-24
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2019-002977-69

A.3

Full title of the trial

Durability of combination of insulin and GLP-1 receptor agonist or SGLT-2 inhibitors versus basal bolus insulin regimen in type 2 diabetes: a randomized controlled trial

Durability della terapia di combinazione di insulina basale e agonista recettoriale del GLP-1 o SGLT-2 inibitore versus regime di terapia insulinica basal bolus nel diabete tipo 2: studio clinico randomizzato controllato

A.3.1

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

Durability of combination of insulin and GLP-1 receptor agonist or SGLT-2 inhibitors versus basal bolus insulin regimen in type 2 diabetes: a randomized controlled trial

A.3.2

Name or abbreviated title of the trial where available

BEYOND

A.4.1

Sponsor's protocol code number

BEYOND

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	A.O.U. Università degli Studi della Campania "Luigi Vanvitelli"
B.1.3.4	Country	Italy
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	A.O.U. Università degli studi della Campania "L. Vanvitelli"
B.5.2	Functional name of contact point	U.O.C. di Endocrinologia e Malattie
B.5.3	Address:
B.5.3.1	Street Address	piazza miraglia, 2
B.5.3.2	Town/ city	Napoli
B.5.3.3	Post code	80138
B.5.3.4	Country	Italy
B.5.4	Telephone number	0815665289
B.5.5	Fax number	0815665032
B.5.6	E-mail	mariaida.maiorino@unicampania.it

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.2.5	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.3.1	Product name	Insulina basale/GLP-1RA in rapporto fisso
D.3.2	Product code	[IGlarLixi]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	00166201
D.3.9.1	CAS number	160337-95-1
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	00795700
D.3.9.1	CAS number	320367-13-3
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Lixisenatide is a recombinant DNA produced polypeptide analogue of human glucagon-like peptide-1 (GLP-1)
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	up to
D.3.10.3	Concentration number	150
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.IMP: 2
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.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.1	Product name	SGLT2-i
D.3.2	Product code	[SGLT2 inibitori]
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	00327100
D.3.9.2	Current sponsor code	NA
D.3.9.4	EV Substance Code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.IMP: 3
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.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.1	Product name	insulina basale ad azione lenta
D.3.2	Product code	[insulina basale]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	00166201
D.3.9.1	CAS number	160337-95-1
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.IMP: 4
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	XULTOPHY - 100 UNITÀ/ML+3,6 MG/ML SOLUZIONE INIETTABILE - USO SOTTOCUTANEO - PENNA PRERIMPITA (PP) - 3 PENNE PRERIEMPITE
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVO NORDISK A/S
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.3.1	Product name	insulina basale/GLP-1RA in rapporto fisso
D.3.2	Product code	[IDegLira]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	00165902
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	IU international unit(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	300
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	00316000
D.3.9.1	CAS number	204656-20-2
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	11
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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.IMP: 5
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.2.1.2	Country which granted the Marketing Authorisation	Italy
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.3.1	Product name	analogo rapido di insulina
D.3.2	Product code	[insulina ultra-rapida]
D.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	00633500
D.3.9.1	CAS number	133107-64-9
D.3.9.2	Current sponsor code	NA
D.3.10	Strength
D.3.10.1	Concentration unit	IU/ml international unit(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

Type 2 diabetes mellitus

Diabete mellito di tipo 2

E.1.1.1

Medical condition in easily understood language

multifactorial disease characterized by the combination of peripheral insulin resistance and impaired insulin secretion by pancreatic beta cells.

malattia su base multifattoriale caratterizzata dalla combinazione di resistenza all'insulina periferica e alterata secrezione di insulina da parte delle cellule beta pancreatiche.

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10067585
E.1.2	Term	Type 2 diabetes mellitus
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10067585
E.1.2	Term	Type 2 diabetes mellitus
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Determine whether the basal insulin / GLP-1RA combination therapy in fixed ratio or basal insulin / SGLT2-i results in a better durability of the glycemic control compared to the insulin basal bolus regimen in patients with non-target type 2 diabetes with multi-insulin regimen injecting.

Determinare se la terapia di combinazione insulina basale/GLP-1RA in rapporto fisso o insulina basale/SGLT2-i risulti in una migliore durability del controllo glicemico rispetto al regime insulinico basal bolus in pazienti con diabete tipo 2 non a target con regime insulinico multi-iniettivo.

E.2.2

Secondary objectives of the trial

Evaluate the effects of basal / GLP-1RA insulin combination therapy in fixed ratio or basal insulin / SGLT2-i on clinical indicators of glyco-metabolic control compared to the insulin basal bolus regimen in patients with non-target type 2 diabetes with multi insulin regimen -iniettivo. Specifically, the variations of the main clinical outcomes will be measured:
1. glycemic control parameters (fasting blood glucose - FPG - and post-prandial - PPG)
2. lipid structure (total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides)
3. body weight and body mass index (BMI)
4. waist circumference (CV)
5. arterial pressure (PA)
6. Glomerular filtration rate (GFR)
The following changes will also be evaluated:
1. C-peptide
2. Insulin doses
3. Diabetes Treatment Questionnaire (DTSQ)

Valutare gli effetti della terapia di combinazione insulina basale/GLP-1RA in rapporto fisso o insulina basale/SGLT2-i sugli indicatori clinici di controllo glico-metabolico rispetto al regime insulinico basal bolus in pazienti con diabete tipo 2 non a target con regime insulinico multi-iniettivo. Nello specifico verranno misurate le variazioni dei principali esiti clinici:
1. parametri di controllo glicemico (glicemia a digiuno - FPG - e post-prandiale - PPG)
2. assetto lipidico (colesterolo totale, LDL-colesterolo, HDL-colesterolo e trigliceridi)
3. peso corporeo e body Mass Index (BMI)
4. circonferenza vita (CV)
5. pressione arteriosa (PA)
6. velocità di filtrazione glomerulare (GFR)
Verranno, altresì, valutate, le variazioni di:
1. C-peptide
2. Dosi di insulina
3. Questionario sulla soddisfazione del trattamento anti-diabete (DTSQ)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Patients on insulin therapy basal bolus stable for at least one year associated or not with metformin
• Insufficient glycemic control (HbA1c> 7.5%

• Pazienti in terapia insulinica basal bolus stabile da almeno un anno associato o meno a metformina
• Controllo glicemico insufficiente (HbA1c > 7.5%)

E.4

Principal exclusion criteria

• Type 1 diabetes or diabetes secondary to specific causes
• Previous treatment (within the last 3 months) with a GLP-1RA or a DPPIV inhibitor
• Contraindications to the use of GLP-1RA (pancreatitis, gallbladder stones)
• Pregnancy or pregnancy scheduled during the study period
• Serum creatinine> 1.3 mg / dL in women and> 1.4 mg / dL in men
• GFR <30 ml / min
• History of cancer or anti-neoplastic therapy in the 5 years prior to randomization
• Current therapy with oral, topical or systemic glucocorticoids, or with atypical anti-psychotics.

• Diabete tipo 1 o diabete secondario a cause specifiche
• Precedente trattamento (negli ultimi 3 mesi) con un GLP-1RA o un DPPIV inibitore
• Controindicazioni all’utilizzo di GLP-1RA (pancreatite, calcolosi della colecisti)
• Gravidanza o gravidanza programmata nel periodo di tempo dello studio
• Creatinina sierica > 1.3 mg/dL nelle donne e > 1.4 mg/dL negli uomini
• GFR < 30 ml/min
• Storia di cancro o di terapia anti-neoplastica nei 5 anni precedenti la randomizzazione
• Terapia corrente con glucocorticoidi per via orale, topica o sistemica, o con anti-psicotici atipici.

E.5 End points

E.5.1

Primary end point(s)

Durability of glycemic control intended as:
• persistent HbA1c variability of 30% during follow-up
• proportion of patients experiencing an improvement in HbA1c as a reduction =0.5% compared to the levels measured at baseline during follow-up

Durability del controllo glicemico inteso come:
• variabilità persistente dell’HbA1c del 30% durante il follow-up
• proporzione di pazienti che vanno incontro ad un miglioramento dell’HbA1c inteso come riduzione =0.5% rispetto ai livelli misurati al basale durante il follow-up

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 mesi

E.5.2

Secondary end point(s)

Variation of:
• body weight and BMI
• waist circumference
• blood pressure
• fasting blood sugar
• post-prandial blood glucose
• C-peptide
• daily insulin doses
• lipid structure (total cholesterol, LDL- and HDL-cholesterol and triglycerides)
• glomerular filtration rate (GFR)
• anti-diabetes treatment satisfaction (DTSQ)

Variazione di:
• peso corporeo e BMI
• circonferenza vita
• pressione arteriosa
• glicemia a digiuno
• glicemia post-prandiale
• C-peptide
• dosi di insulina giornaliere
• assetto lipidico (colesterolo totale, LDL- e HDL-colesterolo e trigliceridi)
• velocità di filtrazione glomerulare (GFR)
• soddisfazione del trattamento anti-diabete (DTSQ)

E.5.2.1

Timepoint(s) of evaluation of this end point

12 months

12 mesi

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

Yes

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

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

Information not present in EudraCT

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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.1.2.1

Number of subjects for this age range:

110

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

110

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

110

F.4.2

For a multinational trial

F.4.2.1

In the EEA

110

F.4.2.2

In the whole clinical trial

110

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)

Outpatient clinical checks according to routine clinical practice with planned checks every 3-6 months

Controlli clinici ambulatoriali secondo pratica clinica di routine con controlli pianificati ogni 3- 6 mesi

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

2019-11-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-11-14

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

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IMP with orphan designation in the indication
Orphan Designation Number:
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