Clinical Trials Register

Summary
EudraCT Number:	2018-003406-11
Sponsor's Protocol Code Number:	NN1436-4465
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2019-04-12
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

Spain - AEMPS

A.2

EudraCT number

2018-003406-11

A.3

Full title of the trial

A trial comparing NNC0148-0287 C (insulin 287) versus insulin glargine U100, both in combination with metformin, with or without DPP4 inhibitors and with or without SGLT2 inhibitors, in insulin-naïve subjects with type 2 diabetes mellitus

Ensayo comparando NNC0148-0287 C (insulina 287) frente a insulina glargina U100, ambos en combinación con metformina, con o sin tratamiento con inhibidores de DPP-4 y con o sin tratamiento con inhibidores de SGLT2, en sujetos con diabetes mellitus tipo 2 sin tratamiento previo con insulina.

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: insulin 287 and insulin glargine in people with type 2 diabetes who have not used insulin before

Estudio de investigación para comparar dos tipos de insulina: insulina 287 e insulina glargina, en personas con diabetes tipo 2 que no han utilizado insulina con anterioridad

A.4.1

Sponsor's protocol code number

NN1436-4465

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1219-5474

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 A/S
B.1.3.4	Country	Denmark
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	Bagsvaerd
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.3.2	Product code	NNC0148-0287 C 4200 nmol/mL
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	N/A
D.3.9.1	CAS number	MASKED
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	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	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 U/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.3.4	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	Insulin Glargine
D.3.9.1	CAS number	160337-95-1
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	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	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

Diabetes mellitus tipo 2

E.1.1.1

Medical condition in easily understood language

Type 2 diabetes

Diabetes 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	20.1
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 compare the effect on glycaemic control of once weekly insulin 287 using 3 different titration algorithms, versus once daily insulin glargine U100, both in combination with metformin ± DPP4i ± SGLT2i in insulin-naïve T2DM subjects

Evaluar el efecto sobre el control de la glucemia de la insulina 287 administrada una vez a la semana, utilizando 3 algoritmos diferentes de ajuste de la dosis, en comparación con la insulina glargina U100 una vez al día, ambas en combinación con metformina ± iDPP4 ± SGLT2, en pacientes con diabetes mellitus tipo2 no tratados previamente con insulina

E.2.2

Secondary objectives of the trial

To compare the safety and tolerability of once weekly insulin 287 using 3 different titration algorithms versus once daily insulin glargine U100 both in combination with metformin ± DPP4i ± SGLT2i in insulin-naïve T2DM subjects

Evaluar el efecto sobre la seguridad y la tolerabilidad de la insulina 287 administrada una vez a la semana, utilizando 3 algoritmos diferentes de ajuste de la dosis, en comparación con la insulina glargina U100 una vez al día, ambas en combinación con metformina ± iDPP4 ± SGLT2, en pacientes con diabetes mellitus tipo2 no tratados previamente con insulina.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female, aged 18-75 years (both inclusive) at the time of signing informed consent.
2. Diagnosed with type 2 diabetes mellitus 180 days or longer prior to the day of screening.
3. HbA1c of 7.0-10.0% (53.0-85.8 mmol/mol) (both inclusive) as assessed by central laboratory.
4. Stable daily dose(s) for 90 days prior to the day of screening of any of the following antidiabetic drug(s) or combination regime(s):
a. Any metformin formulations equal to or above 1500 mg or maximum tolerated or effective dose (as documented in subject’s medical records)
b. Free or fixed combination therapy: Metformin as outlined above with or without DPP4i with or without SGLT2i is allowed:
b. 1: DPP4i (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose)
b.2: SGLT2i (equal to or above half of the maximum approved dose according to local label or maximum tolerated or effective dose )
5. 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.
6. Body mass index (BMI) equal to or above 40.0 kg/m^2

1. Varón o mujer de 18 75 años (ambos inclusive) en el momento de firmar el documento de consentimiento informado.
2. Diagnóstico de diabetes mellitus tipo 2 ≥180 días antes del día de la selección.
3. HbA1c del 7,0% 10,0% (53,0 85,8 mmol/mol) (ambos inclusive) evaluada por el laboratorio central.
4. Dosis diaria estable de los siguientes antidiabéticos o pautas combinadas durante 90 días antes del día de la selección:
a. Cualquier formulación de metformina ≥1500mg o a la dosis máxima tolerada o la dosis efectiva (lo que esté documentado en la historia clínica del paciente).
b. Terapia de combinación libre o fija: se permite metformina como se describe anteriormente ± DPP4i ± SGLT2i:
b.1. DPP4i (≥ la mitad de la dosis máxima aprobada según la etiqueta local o la dosis máxima tolerada o efectiva)
b.2. SGLT2i (≥ la mitad de la dosis máxima aprobada según la etiqueta local o la dosis máxima tolerada o efectiva)
5. Sin tratamiento previo con insulina. No obstante, se permite un tratamiento con insulina de corta duración durante un máximo de 14 días previos al día de la selección, así como el tratamiento previo con insulina para la diabetes gestacional.
6. Índice de masa corporal (IMC) ≤40,0kg/m2.

E.4

Principal exclusion criteria

1. Known or suspected hypersensitivity to trial product(s) or related products.
2. Previous participation in this trial. Participation is defined as signed informed consent.
3. Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method.
4. Participation in any clinical trial, of an approved or non-approved investigational medicinal product within 90 days before screening.
5. Any disorder, except for conditions associated with type 2 diabetes mellitus, which in the investigator’s opinion might jeopardise subject’s safety or compliance with the protocol.
6. Any episodes of diabetic ketoacidosis within the past 90 days, prior to the day of screening and between screening and randomisation.
7. Myocardial infarction, stroke, hospitalisation for unstable angina pectoris or transient ischaemic attack within 180 days prior to the day of screening and between screening and randomisation.
8. Presently classified as being in New York Heart Association (NYHA) Class IV.
9. Planned coronary, carotid or peripheral artery revascularisation between screening and randomisation.
10. Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of eGFR below 60 ml/min/1.73 m^2 as defined by KDIGO 2012.
11. Impaired liver function, defined as Alanine Aminotransferase (ALT) equal to or above 2.5 times or Bilirubin above 1.5 times upper normal limit at screening.
12. Inadequately treated blood pressure, defined as Grade 3 hypertension or higher (Systolic equal to or above 180 mmHg or diastolic equal to or above 110 mmHg) at screening.
13. Treatment with any medication for the indication of diabetes, or obesity other than stated in the inclusion criteria within the past 90 days, prior to the day of screening. 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.
14. 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.
15. Presence or history of malignant neoplasms within 5 years prior to the day of screening. Basal and squamous cell skin cancer and any carcinoma in-situ are allowed.

1. Hipersensibilidad conocida o sospechada a los productos de investigación o productos relacionados.
2. Participación previa en este ensayo. La participación se define como la firma del consentimiento informado.
3. Mujeres embarazadas, que estén en periodo de lactancia o que tengan intención de quedarse embarazadas o que estando en edad fértil no utilicen un método anticonceptivo adecuado.
4. Participación en cualquier ensayo clínico de un medicamento en investigación aprobado o no aprobado dentro de los 90 días anteriores a la selección.
5. Cualquier trastorno, excepto las afecciones asociadas con la diabetes mellitus tipo 2, que en opinión del investigador puedan poner en peligro la seguridad del sujeto o el cumplimiento del protocolo.
6. Cualquier episodio de cetoacidosis diabética en los últimos 90 días, antes del día de la selección y entre la selección y la aleatorización.
7. Infarto de miocardio, ictus, hospitalización por angina inestable o accidente isquémico transitorio en los 180 días previos a la selección y durante selección y aleatorización.
8. Actualmente clasificado en la clase IV de la New York Heart Association (NYHA).
9. Revascularización planificada de la arteria coronaria, carótida o periférica entre la selección y aleatorización.
10. Insuficiencia renal medida como el valor estimado de la tasa de filtración glomerular (eGFR) de eGFR por debajo de 60 ml / min / 1.73 m ^ 2, según lo define KDIGO 2012.
11. Deterioro de la función hepática, definida como alanina aminotransferasa (ALT) igual o superior a 2,5 veces o bilirrubina por encima de 1,5 veces el límite superior de la normalidad en la selección.
12. Presión arterial tratada de manera inadecuada, definida como hipertensión de grado 3 o superior (sistólica igual o superior a 180 mmHg o diastólica igual o superior a 110 mmHg) en la selección.
13. Tratamiento con cualquier medicamento para la indicación de diabetes u obesidad que no se indique en los criterios de inclusión en los últimos 90 días, antes de la selección. Sin embargo, se permite el tratamiento con insulina a corto plazo durante un máximo de 14 días antes del día de la selección, al igual que el tratamiento previo con insulina para la diabetes gestacional.
14. Retinopatía diabética o maculopatía no controlada y potencialmente inestable. Verificado por un examen de fondo de ojo realizado en los últimos 90 días antes de la selección o en el período entre la selección y la aleatorización. La dilatación farmacológica de la pupila es un requisito a menos que se utilice una cámara fotográfica digital de fondo de ojo especificada para el examen sin dilatación.
15. Presencia o antecedentes de neoplasias malignas dentro de los 5 años anteriores al día de la selección. Se permiten el cáncer de piel de células basales y de células escamosas y cualquier carcinoma in situ.

E.5 End points

E.5.1

Primary end point(s)

Time in target range 3.9–10.0 mmol/L (70-180 mg/dL) measured using continuous glucose monitoring (CGM)

Tiempo en el rango objetivo 3.9-10.0 mmol / L (70-180 mg / dL) medido usando el medidor continuo de glucosa (CGM)

E.5.1.1

Timepoint(s) of evaluation of this end point

During the last 2 weeks of treatment (week 15 and 16)

Durante las últimas 2 semanas de tratamiento (semanas 15 y 16)

E.5.2

Secondary end point(s)

1. Change in HbA1c
2. Change in fasting plasma glucose (FPG)
3. Change in body weight
4. Weekly insulin dose
5. Number of treatment emergent adverse events (TEAEs)
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) or severe hypoglycaemic episodes (level 3)
8. Number of hypoglycaemic alert episodes (level 1) (equal to or above 3.0 and below 3.9 mmol/L (equal to or above 54 and below 70 mg/dL), confirmed by BG meter)

1. Cambio en la HbA1c
2. Cambio en la glucosa plasmática en ayunas (FPG)
3. Cambio en el peso corporal
4. Dosis semanal de insulina
5. Número de eventos adversos emergentes del tratamiento (TEAEs)
6. Número de episodios hipoglucémicos graves (nivel 3)
7. Número de episodios de hipoglucemia clínicamente significativos (nivel 2) (por debajo de 3.0 mmol / L (54 mg / dL), confirmados por glucómetro) o episodios de hipoglucemia grave (nivel 3)
8. Número de episodios de alerta de hipoglucemia (nivel 1) (igual o superior a 3,0 e inferior a 3,9 mmol / L (igual o superior a 54 e inferior a 70 mg / dL), confirmado por un glucómetro)

E.5.2.1

Timepoint(s) of evaluation of this end point

1.-3. From baseline week 0 (V2) to week 16 (V18)
4. During the last 2 weeks of treatment (week 15 and 16)
5. From baseline week 0 (V2) to week 21 (V20)
6.-8. From baseline week 0 (V2) to week 16 (V18)

1.-3. Desde la semana basal 0 (V2) hasta la semana 16 (V18)
4. Durante las últimas 2 semanas de tratamiento (semanas 15 y 16)
5. Desde la semana basal 0 (V2) hasta la semana 21 (V20)
6.-8. Desde la semana basal 0 (V2) hasta la semana 16 (V18)

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

Yes

E.6.13.1

Other scope of the trial description

Tolerability

Tolerabilidad

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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)

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

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

European Union

United States

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

UVUP

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:

100

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

160

F.4.2.2

In the whole clinical trial

200

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

Ninguno

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

2019-05-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-05-10

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2020-01-17

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