Clinical Trials Register

Summary
EudraCT Number:	2020-000442-34
Sponsor's Protocol Code Number:	NN1436-4477
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:	2021-06-15
Trial results	View 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

2020-000442-34

A.3

Full title of the trial

A 78-week trial comparing the effect and safety of once weekly insulin icodec and once daily insulin glargine 100 units/mL, both in combination with non-insulin anti-diabetic treatment, in insulin naïve subjects with type 2 diabetes.

Studio clinico di 78 settimane per confrontare gli effetti e la sicurezza dell’insulina settimanale icodec e dell’insulina giornaliera glargine 100 unità/mL, entrambe in combinazione con un trattamento antidiabetico non insulinico, in soggetti con diabete di tipo 2 che non hanno mai assunto insulina prima

A.3.1

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

A research study to compare two types of insulin, a new insulin, insulin icodec and an available insulin, insulin glargine, in people with type 2 diabetes who have not used insulin before

Studio clinico di confronto tra due tipi di insuline, una nuova (insulina icodec) ed una già conosciuta (insulina glargine), in persone con diabete di tipo 2 che non hanno mai assunto insulina prima

A.3.2

Name or abbreviated title of the trial where available

ONWARDS 1

A.4.1

Sponsor's protocol code number

NN1436-4477

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1247-3878

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	NOVO NORDISK. S.P.A.
B.1.3.4	Country	Italy
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Novo Nordisk A/S
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Novo Nordisk A/S
B.5.2	Functional name of contact point	Clinical Disclosure (1452)
B.5.3	Address:
B.5.3.1	Street Address	Novo Allé
B.5.3.2	Town/ city	Bagsværd
B.5.3.3	Post code	2880
B.5.3.4	Country	Denmark
B.5.6	E-mail	clinicaltrials@novonordisk.com

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	No
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	insulin icodec 700 U/mL PDS290
D.3.2	Product code	[.]
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.3.9.2	Current sponsor code	Insulina 287
D.3.9.3	Other descriptive name	INSULIN 287
D.3.9.4	EV Substance Code	SUB50453
D.3.10	Strength
D.3.10.1	Concentration unit	nmol/ml nanomole(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4200
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	Yes
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	Comparator
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	Lantus 100 units/mL
D.2.1.1.2	Name of the Marketing Authorisation holder	Sanofi-Aventis
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Lantus
D.3.2	Product code	[N/A]
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	Insulina glargine
D.3.9.1	CAS number	160337-95-1
D.3.9.2	Current sponsor code	N/A
D.3.9.3	Other descriptive name	Insulin glargine
D.3.9.4	EV Substance Code	SUB08196MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml 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	Yes
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

Diabetes Mellitus, Type 2

Diabete mellito di tipo 2

E.1.1.1

Medical condition in easily understood language

Type 2 diabetes

Diabete di tipo 2

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	LLT
E.1.2	Classification code	10045242
E.1.2	Term	Type II diabetes mellitus
E.1.2	System Organ Class	100000004861

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To demonstrate the effect on glycaemic control of once weekly insulin icodec, in combination with non-insulin anti-diabetic drugs, in insulin naïve subjects with type 2 diabetes (T2D). This includes comparing the difference in change from baseline in glycosylated haemoglobin (HbA1c) between insulin icodec and insulin glargine after 52 weeks of treatment to a non-inferiority limit of 0.3%.

Dimostrare l'effetto sul controllo glicemico dell'insulina icodec assunta una volta alla settimana, in combinazione con farmaci antidiabetici non insulinici, in soggetti con diabete di tipo 2 che non hanno mai assunto insulina prima. A tal fine si valuta la differenza nella variazione rispetto al basale dell'emoglobina glicosilata (HbA1c) tra insulina icodec e insulina glargine dopo 52 settimane di trattamento ad un limite di non inferiorità dello 0,3%.

E.2.2

Secondary objectives of the trial

To compare parameters of glycaemic control and safety of once weekly insulin icodec with once daily insulin glargine, both in combination with non-insulin anti-diabetic drugs, in insulin naïve subjects with T2D.

Confrontare dei parametri di controllo glicemico e sicurezza dell'insulina icodec assunta una volta alla settimana rispetto all'insulina glargine assunta una volta al giorno, entrambe in combinazione con farmaci antidiabetici non insulinici, in soggetti con diabete di tipo 2 che non hanno mai assunto insulina prima.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Male or female aged above or equal to 18 years at the time of signing informed consent.
- Diagnosed with T2D 180 days or more prior to the day of screening.
- HbA1c from 7.0-11.0% (53.0-96.7 mmol/mol) both inclusive at screening confirmed by central laboratory analysis.
- Insulin naïve. However, short term insulin treatment for a maximum of 14 days prior to the day of screening is allowed, as is prior insulin treatment for gestational diabetes.
- Stable daily dose(s) 90 days or more prior to the day of screening of any of the following anti-diabetic drug(s) or combination regimen(s):
a. Any metformin formulations equal to or above 1500 mg or maximum tolerated or effective dose.
b. Any metformin combination formulations equal to or above 1500 mg or maximum tolerated or effective dose.
c. Any of the following oral anti-diabetic drug classes including combinations (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose).
- Sulfonylureas
- Meglitinides (glinides)
- Dipeptidyl peptidase 4 (DPP-4) inhibitors
- Sodium-glucose Cotransporter-2 (SGLT2) inhibitors
- Thiazolidinedione
- Alpha-glucosidase inhibitor
- Oral combination products (for the allowed individual Oral Anti-diabetic Drugs (OADs))
- Oral or injectable glucagon-like peptide 1 (GLP-1)-receptor agonists
- Body mass index (BMI) equal to or below 40.0 kg/m^2

- Soggetti di sesso maschile o femminile, con età pari o superiore a 18 anni al momento della firma del consenso informato
- Diagnosi di diabete mellito di tipo 2 da almeno 180 giorni alla data della visita di screening
- HbA1c (emoglobina glicata) nell'intervallo 7,0-11,0% (53,0-96,7 mmol / mol), estremi compresi, alla visita di screening confermato da analisi presso il laboratorio centrale
- non avere mai assunto insulina prima. Tuttavia, un breve trattamento con insulina per un massimo di 14 giorni prima del giorno dello screening, così come precedenti trattamenti insulinici per il diabete gestazionale
- Dose giornaliera stabile da almeno 90 giorni prima della visita di screening di uno qualsiasi dei seguenti farmaci antidiabetici o regime di associazione:
a. Qualsiasi formulazione di metformina uguale o superiore a 1500 mg o alla dose massima tollerata o efficace
b. Qualsiasi formulazione di combinazione di metformina uguale o superiore a 1500 mg o alla dose massima tollerata o efficace
c. Una delle seguenti classi di farmaci antidiabetici orali, incluso combinazioni (uguali o superiori alla metà della dose massima approvata secondo l'etichetta locale o alla dose massima tollerata o efficace):
- Solfaniluree
- Meglitinidi (glinidi)
- Inibitori della dipeptidil peptidasi 4 (DPP-4)
- Inibitori del sodio-glucosio Cotransporter-2 (SGLT2)
- Tiazolidinedione
- Inibitore dell'alfa-glucosidasi
- Prodotti di combinazione orale (per i singoli farmaci antidiabetici orali consentiti (OAD))
- Agonisti dei recettori del peptide glucagon-like 1 (GLP-1) orali o iniettabili
- Indice di massa corporea (BMI) uguale o inferiore a 40,0 kg/m^2

E.4

Principal exclusion criteria

- Any episodes (as declared by the subject or in the medical records) of diabetic ketoacidosis within 90 days prior to the day of screening.
- Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening.
- Chronic heart failure classified as being in New York Heart Association (NYHA) Class IV at screening.
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism (e.g. treatment with orlistat, thyroid hormones, or corticosteroids).
- Uncontrolled and potentially unstable diabetic retinopathy or maculopathy. Verified by a fundus examination performed within the past 90 days prior to screening or in the period between screening and randomisation. Pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for non-dilated examination.

- Eventuali episodi (dichiarati dal soggetto o nelle cartelle cliniche) di chetoacidosi diabetica entro 90 giorni prima del giorno di screening.
- Infarto del miocardo, ictus, ospedalizzazione per angina pectoris instabile o attacco ischemico transitorio nei 180 giorni precedenti il giorno dello screening.
- Insufficienza cardiaca cronica classificata come appartenente alla Classe IV della New York Heart Association (NYHA) allo screening.
- Inizio o modifica anticipata di farmaci concomitanti (per più di 14 giorni consecutivi) noti per influenzare il peso o il metabolismo del glucosio (ad es. trattamento con orlistat, ormoni tiroidei o corticosteroidi).
- Retinopatia o maculopatia diabetica incontrollata e potenzialmente instabile. Verificato da un esame del fondo eseguito negli ultimi 90 giorni prima dello screening o nel periodo tra lo screening e la randomizzazione. E' richiesta la dilatazione farmacologica della pupilla a meno che non si utilizzi una fotocamera digitale per la fotografia del fondo oculare specificata per l'esame senza dilatazione.

E.5 End points

E.5.1

Primary end point(s)

Change in HbA1c

Variazione nella HbA1c (emoglobina glicata)

E.5.1.1

Timepoint(s) of evaluation of this end point

From baseline week 0 (V2) to week 52 (V46)

Dal valore basale (settimana 0, V2) alla settimana 52 (V46)

E.5.2

Secondary end point(s)

1. Time in target range 3.9-10.0 mmol/L (70-180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
2. Change in fasting plasma glucose (FPG)
3. Number of severe hypoglycaemic episodes (level 3)
4. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL) confirmed by BG meter)
5. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
6. Number of severe hypoglycaemic episodes (level 3)
7. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL) confirmed by BG meter)
8. Number of clinically significant hypoglycaemic episodes (level 2) (below 3.0 mmol/L (54 mg/dL), confirmed by BG meter) or severe hypoglycaemic episodes (level 3)
9. Mean weekly insulin dose
10. Change in body weight
11. Time spent below 3.0 mmol/L (54 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6
12. Time spent below 10 mmol/L (180 mg/dL) using continuous glucose monitoring (CGM) system, Dexcom G6

1. Tempo nell'intervallo target 3,9-10,0 mmol / L (70-180 mg/dL) misurato utilizzando il sistema di monitoraggio continuo del glucosio (CGM), Dexcom G6
2. Variazione della glicemia a digiuno (FPG)
3. Numero di episodi ipoglicemici gravi (livello 3)
4. Numero di episodi ipoglicemici clinicamente significativi (livello 2) (inferiore a 3,0 mmol/L (54 mg/dL) confermato dal glucometro)
5. Numero di episodi ipoglicemici clinicamente significativi (livello 2) (inferiore a 3,0 mmol/L (54 mg/dL), confermato dal glucometro) o episodi ipoglicemici gravi (livello 3)
6. Numero di episodi ipoglicemici gravi (livello 3)
7. Numero di episodi ipoglicemici clinicamente significativi (livello 2) (inferiore a 3,0 mmol/L (54 mg/dL) confermati dal misuratore BG)
8. Numero di episodi ipoglicemici clinicamente significativi (livello 2) (inferiore a 3,0 mmol/L (54 mg/dL), confermati dal misuratore BG) o episodi ipoglicemici gravi (livello 3)
9. Dose settimanale media di insulina
10. Variazione del peso corporeo
11. Tempo trascorso al di sotto di 3,0 mmol/L (54 mg/dL) utilizzando il sistema di monitoraggio continuo del glucosio (CGM), Dexcom G6
12. Tempo trascorso al di sotto di 10 mmol/L (180 mg/dL) utilizzando il sistema di monitoraggio continuo del glucosio (CGM), Dexcom G6

E.5.2.1

Timepoint(s) of evaluation of this end point

1. From week 48 (V42) to week 52 (V46)
2.-5. From baseline week 0 (V2) to week 52 (V46)
6.-8. From baseline week 0 (V2) to week 83 (V63)
9. From week 50 (V44) to week 52 (V46)
10. From baseline week 0 (V2) to week 52 (V46)
11.-12. From week 48 (V42) to week 52 (V46)

1. Dalla settimana 48 (V42) alla settimana 52 (V46)
2.-5. Dalla settimana 0 (V2) (valore basale) alla settimana 52 (V46)
6.-8. Dalla settimana 0 (V2) (valore basale) alla settimana 83 (V63)
9. Dalla settimana 50 (V44) alla settimana 52 (V46)
10. Dalla settimana 0 (V2) (valore basale) alla settimana 52 (V46)
11.-12. Dalla settimana 48 (V42) alla settimana 52 (V46)

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

Yes

E.8.1.7.1

Other trial design description

Trattamento adattato per raggiungere il target

Treat-to-target design

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

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

India

Israel

Japan

Mexico

Russian Federation

United States

European Union

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

LVLS, Last Visit Last Subject, ultima visita dell'ultimo paziente

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:

960

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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.4.2

For a multinational trial

F.4.2.1

In the EEA

325

F.4.2.2

In the whole clinical trial

970

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

Nessuno

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

2020-10-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2020-09-17

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

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