Clinical Trials Register

Summary
EudraCT Number:	2009-011231-12
Sponsor's Protocol Code Number:	EFC11202
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:	2009-10-05
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

2009-011231-12

A.3

Full title of the trial

Estudio multinacional, de grupos paralelos, abierto, aleatorizado, de 24 semanas que compara Lantus® (insulina glargina) administrada por la mañana como insulina basal una vez al día con insulina NPH (Neutral Protamine Hagedorn), en niños con diabetes mellitus tipo 1 entre 1 y menos de 6 años de edad.
__________________________________________________

A 24-week, randomized, open-label, parallel group multinational comparison of Lantus® (insulin glargine) given in the morning as once-a-day basal insulin versus Neutral Protamine Hagedorn (NPH) insulin, in children with type 1 diabetes mellitus aged at least 1 year to less than 6 years

A.3.2

Name or abbreviated title of the trial where available

PRESCHOOL (PRESchool CHildren with type 1 diabetes On mOrning Lantus)

A.4.1

Sponsor's protocol code number

EFC11202

A.7

Trial is part of a Paediatric Investigation Plan

Information not present in EudraCT

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	sanofi-aventis recherche & développement
B.1.3.4	Country	France
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation
B.5.2	Functional name of contact point

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	LANTUS 100 Unidades/ml solución inyectable en un vial
D.2.1.1.2	Name of the Marketing Authorisation holder	SANOFI AVENTIS DEUTSCHLAND GMBH
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Information not present in EudraCT
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 GLARGINA
D.3.9.1	CAS number	160337-95-1
D.3.9.3	Other descriptive name	INSULIN GLARGINE
D.3.10	Strength
D.3.10.1	Concentration unit	EID50/dose 50% Embryo Infective Dose/dose
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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	HUMULINA REGULAR 100 UI/ML solución inyectable en viales
D.2.1.1.2	Name of the Marketing Authorisation holder	LILLY, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	Suspension for injection
D.3.4.1	Specific paediatric formulation	Information not present in EudraCT
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 SOLUBLE NEUTRA HUMANA PRB
D.3.9.3	Other descriptive name	INSULINA SOLUBLE NEUTRA HUMANA PRB
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)	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Information not present in EudraCT
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

Pacientes con diabetes mellitus tipo 1, entre 1 y 6 años

_______________________________________________

Patients with type 1 diabetes mellitus, aged at least 1 year to less than 6 years

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	12.0
E.1.2	Level	LLT
E.1.2	Classification code	10012609
E.1.2	Term	<Manually entered code. Term in E.1.1>

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

EL objetivo principal del estudio es comparar la tasa de "todas las hipoglucemias" entre los niños tratados con insulina glargina y insulina NPH.
__________________________________________________

The primary study objective is to compare the rate of "all hypoglycemia" between children treated with insulin glargine and NPH insulin.

E.2.2

Secondary objectives of the trial

Los objetivos secundarios son comparar la insulina glargina y la insulina NPH en términos de:
- Índices de los tipos específicos de hipoglucemias: sintomática, severa, nocturna, nocturna sintomática, y severa nocturna y sintomática.
- Cambio en HbA1c desde la basal hasta la finalización del tratamiento, y HbA1c al final del tratamiento.
- Porcentaje de pacientes que alcancen HbA1 menor que el 7.5% (valor diana) al finalizar el tratamiento.
- Media de glucosa en sangre durante el ensayo y hasta el fin del tratamiento, monitorizado con CGMS.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Pacientes pediátricos con diabetes mellitus de tipo 1 de al menos 1 año de edad y menores de 6 años, de cuyos padres o tutores se habrá obtenido el consentimiento informado por escrito para participar en el estudio.
___________________________________________
Pediatric patients with type 1 diabetes mellitus aged at least one year to less than 6 years, for whom signed written informed consent has been obtained from parent or legal guardian to participate in the study.

E.4

Principal exclusion criteria

1. Diagnóstico de diabetes de tipo 1 durante menos de 1 año
2. HbA1c en el momento de la selección > 12% o < 6%
3. Diabetes distinta de la diabetes de tipo 1.
4. Los padres y pacientes no están dispuestos a efectuar todas las evaluaciones y tratamientos del estudio, incluida la monitorización de la glucemia en el domicilio, la inserción y mantenimiento del sensor CGMS en el centro y en el domicilio, inyecciones de insulina varias veces al día y las visitas al centro que se indique en el protocolo (si no se dispone de un teléfono, los pacientes pueden acudir a las visitas en persona).
5. Pacientes y familias en los que no se puedan obtener 6 días en total (no necesariamente consecutivos) de datos útiles con el CGMS (ya sea mediante la sustitución del sensor en el domicilio o mediante la inserción del sensor en el centro en otra visita de selección, si fuera necesario) durante las evaluaciones de selección con el CGMS entre la Visita 2 y la visita de aleatorización
6. Pacientes tratados con bomba de insulina durante los dos meses previos a la selección
7. Antecedentes de trastorno convulsivo primario
8. Antecedentes de episodios intensos de hipoglucemia acompañados de convulsiones y/o coma, o cetoacidosis diabética que cause la hospitalización o la asistencia en un servicio de urgencias, en los 2 meses previos a la visita de selección
9. Desconocimiento de la hipoglucemia, determinada por el Investigador
10. Creatinina sérica > 2,0 mg/dl en la selección
11. ALT o AST séricas mayores de 3 veces el límite superior de la normalidad para la edad y sexo del paciente en el momento de la selección
12. Hemoglobina < 10 g/dl, o recuento de plaquetas menor de 100 000/mm3 en la selección
13. Tratamiento con cualquier fármaco hipoglucemiante oral en cualquier momento desde el diagnóstico de la diabetes
14. Tratamiento con cualquier medicamento hipoglucemiante distinto de la insulina (p. ej., Symlin®) durante los 3 meses previos a la selección
15. Tratamiento con glucocorticoides sistémicos en el mes previo a la selección.

E.5 End points

E.5.1

Primary end point(s)

Índice de acontecimientos de todas las hipoglucemias durante el tratamiento con los medicamentos de estudio, la cual consiste en:
- Glucosa intersticial con CGMS < 70 mg/dl (3,9mM)
- Valores de glucemia en sangre capilar del dedo < 70 mg/dl (3,9mM)
- Episodios sintomáticos de hipoglucemia, validados por el centro según las anotaciones en los diarios de los pacientes
____________________________________________
Event rate of "all hypoglycemia" during treatment with study drugs, which consists of: CGMS glucose <70 mg/dL (3.9mM) , Self-Monitored Blood Glucose values <70 mg/dL (3.9mM), symptomatic hypoglycemia episodes.

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

Yes

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

Information not present in EudraCT

E.7.1.2

Bioequivalence study

Information not present in EudraCT

E.7.1.3

Other

Information not present in EudraCT

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

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

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

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

Yes

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)

Yes

F.1.1.5

Children (2-11years)

Yes

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

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

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Young children (1 to less than 6 year-old)

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

F.4.2.2

In the whole clinical trial

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

2009-12-18

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-11-13

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2011-03-30

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