Clinical Trials Register

Summary
EudraCT Number:	2009-018172-33
Sponsor's Protocol Code Number:	LANTU_C_04589
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:	2010-05-25
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

2009-018172-33

A.3

Full title of the trial

Estudio de 24 semanas de duración, multicéntrico, abierto y comparativo de dos estrategias (insulina glargina frente a insulina premezclada) para el tratamiento de pacientes con diabetes de tipo 2 que han fracasado a los fármacos orales

A 24-week, open, multicenter, comparative study of 2 strategies (including insulin glargine versus premixed insulin) for the therapeutic management of patients with type 2 diabetes failing oral agents

A.3.2

Name or abbreviated title of the trial where available

GALAPAGOS

A.4.1

Sponsor's protocol code number

LANTU_C_04589

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 GROUPE
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 pluma precargada
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	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.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.2.1.1.1	Trade name	APIDRA 100 Unidades/ml,solostar solución inyectable en pluma precargada
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 GLULISINA
D.3.9.3	Other descriptive name	INSULIN GLULISINE
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.IMP: 3
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	NOVOMIX 30 Flexpen 100 U/ml, suspensión inyectable en una pluma precargada
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVO NORDISK A/S
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	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 ASPARTA
D.3.9.3	Other descriptive name	INSULIN ASPART
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

Diabetes tipo 2 con fracaso a las intervenciones en el estilo de vida y a los fármacos orales

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	11
E.1.2	Level	LLT
E.1.2	Classification code	10063624
E.1.2	Term	Diabetes melitus tipo II inadecuadamente controlada

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Demostrar la superioridad de una estrategia con insulina glargina en comparación con una estrategia con insulina premezcla en cuanto a porcentaje de pacientes que consiguen un valor de HbA1c inferior al 7% al final del período de tratamiento sin experimentar hipoglucemia sintomática documentada (confirmada por glucosa plasmática [GP] ≤ 56 mg/dl (3,1 mmol/l) durante el período de tratamiento, en pacientes con diabetes de tipo 2 en los que el tratamiento con estilo de vida y fármacos orales ha fracasado

E.2.2

Secondary objectives of the trial

Evaluar el efecto de la insulina glargina en comparación con la insulina premezcla en:
-Evolución de los niveles de HbA1c durante el período de tratamiento
-Porcentaje de pacientes que logran el objetivo de HbA1c < 7 % y que no experimentan hipoglucemia sintomática documentada, confirmada por una GP ≤ 70 mg/dl (3,9 mmol/l)
-Porcentaje de pacientes que logran el objetivo de HbA1c < 6,5% y que no experimentan hipoglucemia sintomática documentada, confirmada por una GP ≤ 56 mg/dl (3,1 mmol/l)
-Porcentaje de pacientes que logran el objetivo de HbA1c < 6,5% y que no experimentan hipoglucemia sintomática documentada, confirmada por una GP ≤ 70 mg/dl (3,9 mmol/l)
-Evolución de la glucosa plasmática en ayunas
-Evolución de los perfiles de glucosa plasmática de 7 puntos
-Evolución del peso
-Aparición de hipoglucemia
-Dosis de insulinas
-Evolución de la función hepática
- Resultados notificados por el paciente (RNP): cuestionarios DTSQs y DTSQc
-Seguridad global

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Hombres o mujeres ≥ 35 años
• Con diabetes de tipo 2 diagnosticada hace más de un año.
• No tratados previamente con insulina.
• Tratados con intervenciones en el estilo de vida y antidiabéticos orales, al menos metformina a la dosis máxima tolerada (con una dosis mínima de 1 g/día) durante un mínimo de 3 meses.
• HbA1c ≥ 7,0 % y ≤ 10,5%
• IMC ≤ 40 kg/m2
• Capacidad y disposición para realizar una monitorización de la glucosa plasmática (GP) mediante el glucómetro entregado por el promotor y rellenar el diario del paciente.
• Disposición y capacidad para cumplir con el protocolo de estudio.
• Consentimiento informado firmado obtenido antes de cualquier procedimiento del estudio.

E.4

Principal exclusion criteria

• Tratamiento con agonistas GLP-1 en los 3 meses previos a la entrada en el estudio.
• Tratamiento previo con insulina (excepto para el tratamiento de la diabetes gestacional o tratamiento ocasional con insulina durante menos de 1 semana).
• Diabetes que no sea de tipo 2 (p. ej., diabetes de tipo 1, diabetes secundaria a trastornos pancreáticos, uso de fármacos o sustancias químicas,…).
• Mujeres embarazadas o en período de lactancia
• Paciente hospitalizado (excepto para un examen rutinario de la diabetes)
• Retinopatía proliferativa activa, definida por fotocoagulación o vitrectomía en los 6 meses previos a la entrada en el estudio, o cualquier otra retinopatía inestable (de progresión rápida) que pueda requerir fotocoagulación o tratamiento quirúrgico durante el estudio, documentada por exploración de la retina, en los 2 años previos a la entrada en el estudio.
• Antecedentes de sensibilidad a los fármacos del estudio o fármacos de estructura química similar.
• Alteración de la función renal: aclaramiento de creatinina < 60 mL/min
• Alteración de la función hepática (ALT, AST > 3 veces el límite superior de normalidad).
• Enfermedad gastrointestinal grave
• Tratamiento con corticoesteroides con acción sistémica potencial en los 3 meses previos a la entrada en el estudio.
• Abuso de alcohol o drogas en los 5 últimos años
• Trabajador de turno de noche
• Presencia de cualquier situación (médica, psicológica, social o geográfica), actual o prevista que pueda comprometer la seguridad del paciente o limitar el éxito de su participación en el estudio

E.5 End points

E.5.1

Primary end point(s)

El criterio principal de eficacia será el porcentaje de pacientes con un valor de HbA1c < 7% al final del período de tratamiento, sin hipoglucemia sintomática documentada (confirmada por una GP menor o igual a 56 mg/dl) en el período de tratamiento de 24 semanas.

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

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)

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.8.3

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	No
F.1.1.1	In Utero	Information not present in EudraCT
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	Information not present in EudraCT
F.1.1.3	Newborns (0-27 days)	Information not present in EudraCT
F.1.1.4	Infants and toddlers (28 days-23 months)	Information not present in EudraCT
F.1.1.5	Children (2-11years)	Information not present in EudraCT
F.1.1.6	Adolescents (12-17 years)	Information not present in EudraCT
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	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	80
F.4.2	For a multinational trial
F.4.2.1	In the EEA	278
F.4.2.2	In the whole clinical trial	870

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

2010-05-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2010-05-14

P. End of Trial
P.	End of Trial Status	Completed

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