Clinical Trials Register

Summary
EudraCT Number:	2006-002519-28
Sponsor's Protocol Code Number:	F3Z-MC-IOOX
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2006-07-31
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

Spain - AEMPS

A.2

EudraCT number

2006-002519-28

A.3

Full title of the trial

Ensayo PRIME DT2: Regímenes prandiales-basales de Insulina para mejorar la glucemia post-pandrial en Diabetes Tipo 2.Comparación de dos enfoques con terapia basal y en bolo en pacientes con Diabetes tipo 2 en terapia oral y un inadecuado control glucemico; comparación de Insulina Lispro premezclada de proporción media (50-50) con inyecciones separadas de Insulina basal y en bolo

A.3.2

Name or abbreviated title of the trial where available

IOOX

A.4.1

Sponsor's protocol code number

F3Z-MC-IOOX

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	Lilly S.A.
B.1.3.4	Country	Spain
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	Information not present in EudraCT
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	Humalog
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	insulin lispro
D.3.9.1	CAS number	133107-64-9
D.3.9.2	Current sponsor code	LY275585[P]
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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	Information not present in EudraCT
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	Humalog
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	insulin lispro
D.3.9.1	CAS number	133107-64-9
D.3.9.2	Current sponsor code	LY275585[P]
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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	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	Information not present in EudraCT
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	Humalog
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	insulin lispro
D.3.9.1	CAS number	133107-64-9
D.3.9.2	Current sponsor code	LY275585[P]
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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: 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	Information not present in EudraCT
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	Humalog Mix25
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	insulin lispro
D.3.9.1	CAS number	133107-64-9
D.3.9.2	Current sponsor code	LY275585[P]
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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: 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	Information not present in EudraCT
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	Humalog Mix25
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	insulin lispro
D.3.9.1	CAS number	133107-64-9
D.3.9.2	Current sponsor code	LY275585[P]
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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: 6
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	Information not present in EudraCT
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	Humalog Mix25
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	insulin lispro
D.3.9.1	CAS number	133107-64-9
D.3.9.2	Current sponsor code	LY275585[P]
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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: 7
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	Information not present in EudraCT
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	Humalog Mix50
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	insulin lispro
D.3.9.1	CAS number	133107-64-9
D.3.9.2	Current sponsor code	LY275585[P]
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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: 8
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	Information not present in EudraCT
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	Humalog Mix50
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	insulin lispro
D.3.9.1	CAS number	133107-64-9
D.3.9.2	Current sponsor code	LY275585[P]
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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: 9
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	Information not present in EudraCT
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	Humalog Mix50
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	insulin lispro
D.3.9.1	CAS number	133107-64-9
D.3.9.2	Current sponsor code	LY275585[P]
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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: 10
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	Information not present in EudraCT
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.3.4	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	insulin glargine
D.3.9.1	CAS number	160337-95-1
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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: 11
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	Information not present in EudraCT
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.3.4	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	insulin glargine
D.3.9.1	CAS number	160337-95-1
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	Information not present in EudraCT
D.3.11.8	Extractive medicinal product	Information not present in EudraCT
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 II

MedDRA Classification

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 primario de este estudio es verificar la hipótesis de que, en pacientes con diabetes tipo 2 que tienen un control glucémico inadecuado y toman las dosis máximas toleradas de antidiabéticos orales (ADO) sin insulina, el inicio de la utilización de insulina con una inyección de insulina lispro de media mezcla (MM) , progresando hasta tres inyecciones diarias de insulina lispro premezclada (insulina lispro MM tres veces al día con la posibilidad de sustituir la dosis de insulina lispro MM de la cena por una insulina lispro de baja mezcla [LM] ) añadida al tratamiento oral existente no es inferior respecto al control glucémico obtenido con el inicio de la utilización de insulina con insulina glargina una vez al día progresando de una a tres inyecciones adicionales de insulina lispro (glargina con o sin lispro) añadida al tratamiento oral existente, según la determinación de la hemoglobina A1c (HbA1c) al final del estudio.

E.2.2

Secondary objectives of the trial

• HbA1c a las 12 semanas y 24 semanas
• en análisis separados, el porcentaje de pacientes que consiguieron una HbA1c , 7% y 7% a las 12 semanas, 24 semanas, 36 semanas y al final del estudio
• los perfiles de los autoanálisis de la glucosa sanguínea (AAGS) de 7 puntos al inicio del estudio, a las 12 semanas, 24 semanas, 36 semanas y al final del estudio, incluyendo la variabilidad glucémica y el valor de M
• dosis de insulina: total, basal y prandial
• número de inyecciones al día
• seguridad, que se mide por la incidencia y la frecuencia de episodios hipoglucémicos notificados por el propio paciente, incluyendo hipoglucemia nocturna (y no nocturna); incidencia de hipoglucemia grave; cambio de peso; y acontecimientos adversos aparecidos durante el tratamiento.
.

E.2.3

Trial contains a sub-study

Information not present in EudraCT

E.3

Principal inclusion criteria

[1]Tener diabetes de tipo 2 (clasificación de la Organización Mundial de la Salud [OMS], véase Documento Adjunto al Protocolo IOOX.2).
[2]Tengan al menos 30 años de edad y menos de 80 años de edad.
[3]Hayan estado recibiendo antidiabéticos orales (ADO) sin insulina durante al menos 90 días inmediatamente antes del estudio, incluyendo al menos dos de los siguientes ADO a las dosis máximas toleradas, Y cumplir los criterios posológicos adicionales que se muestran:

ADO Dosis Mínima
Metformina 1500 mg/día
Sulfonilurea 1/2 de la dosis máxima diaria, según la ficha técnica local.
Tiazolidindiona (TZD) 30 mg/día de pioglitazona o 4 mg/día rosiglitazona

Los ADO se deben utilizar también de acuerdo con la ficha técnica del producto y deben estar autorizados para su uso con insulina en el país del paciente (Criterio de exclusión [7]). (Nota: los tratamientos combinados de los ADO que se señalan arriba son aceptables si cumplen los criterios que se indican. Por ejemplo, Avandamet [maleato de rosiglitazona e hidrocloruro de metformina] cubriría las categorías de una TZD y metformina).
[4]Tener una hemoglobina A1c (HbA1c) y  12,0% según la medición de un laboratorio central en la Visita 1.
[5]Según lo determine el investigador, ser capaz y desear realizar lo siguiente:
•utilizar el dispositivo de inyección de insulina de acuerdo con las instrucciones que se le den;
•inyectarse insulina mientras mantienen el régimen previo al estudio de ADO especificado en el criterio de inclusión [3];
•realizarse el autoanálisis de glucosa sanguínea (AAGS);
•utilizar el diario de paciente según los requisitos de este protocolo;
•ser receptivo a la educación sobre la diabetes, incluyendo mantener los niveles de dieta y actividad previos al estudio, o seguir un consejo dietético simple cuando sea necesario;
•cumplir las visitas del estudio necesarias y desear recibir llamadas telefónicas regulares entre las visitas.
[6]Haber dado el consentimiento informado por escrito a participar en este estudio de conformidad con las regulaciones locales.

E.4

Principal exclusion criteria

[7]Estar tomando una dosis de TZD mayor de la que se indica en combinación con insulina según el prospecto de la TZD en su respectivo país. (Por ejemplo, en los Estados Unidos actualmente no está indicada una dosis de rosiglitazona mayor de 4 mg al día o una dosis de pioglitazona mayor de 45 mg al día). En los países en los que está contraindicada una combinación de una TZD e insulina, los pacientes que tomen una TZD deben haber recibido un régimen previo el estudio de tres ADO del criterio de inclusión [3] y deben interrumpir la TZD al menos 2 semanas antes de la aleatorización (Visita 2).
[8]Estar tomando otros antidiabéticos (como meglitinida, inhibidores de la -glucosidasa, etc.) no mencionados en el Criterio de Inclusión [3].
[9]Haber tomado acarbosa, miglitol, pramlintida, exenatida, repaglinida o nateglinida en las 6 semanas previas o durante un total de 30 días o más en las 24 semanas previas.
[10]Tener un índice de masa corporal mayor de 40 kg/m2.
[11]Haber tenido más de un episodio de hipoglucemia grave, como se define en la sección de Abreviaturas y Definiciones, en las 24 semanas previas a su introducción en el estudio.
[12]Estar embarazada o tener previsto quedar embarazada durante la realización del estudio, o ser una mujer sexualmente activa con posibilidad de ser fecundada y que no practica de manera activa medidas de control de la natalidad con un método que el investigador determine que sea médicamente aceptable.
[13]Estar dando lactancia materna.
[14]Tener una cardiopatía con un estado funcional de Clase III o IV (véase el Documento Adjunto al Protocolo IOOX.3); o, si está tomando una TZD, tener una cardiopatía de un estado funcional menos grave, que contraindicaría en su país respectivo la utilización de una TZD sola o combinada con insulina.
[15]Tener antecedentes de trasplante renal o estar recibiendo actualmente diálisis renal.
[16]Tener síntomas o signos clínicos evidentes, o datos de laboratorio, de hepatopatía (mediciones de alanina transaminasa [ALT] o de aspartato transaminasa [AST] 2 veces mayor al límite superior del intervalo de referencia, según la definición del laboratorio local).
[17]Estar recibiendo tratamiento por una neoplasia maligna distinta a un basalioma o epitelioma cutáneo.
[18]Tener hipersensibilidad o alergia conocida a cualquiera de las insulinas del estudio o a los excipientes de las insulinas del estudio.
[19]Haber recibido una transfusión sanguínea o haber tenido una hemorragia grave en los 3 meses previos a la Visita 1 o tener una hemoglobinopatía conocida, anemia hemolítica o anemia drepanocítica.
[20]Haber recibido tratamiento con corticoides sistémicos en los 3 meses previos a la Visita 1. (Nota: se permiten los preparados tópicos, los preparados nasales, la administración intraarticular, así como la sustitución fisiológica por enfermedad de Addison y por hipopituitarismo).
[21]Tener un ciclo sueño/vigilia irregular (por ejemplo, pacientes que duermen durante el día y trabajan durante la noche).
[22]Tener cualquier otra enfermedad (incluyendo abuso conocido de drogas o de alcohol o un trastorno psiquiátrico) que impida que el paciente siga y finalice el protocolo.
[23]Haber recibido tratamiento en los 30 días previos con un fármaco que no haya recibido autorización de las autoridades reguladoras para cualquier indicación en el momento de su inclusión en el estudio.
[24]Ser personal del centro investigador relacionado directamente con este estudio o su familiar inmediato. La familia inmediata se define como cónyuge, progenitor, hijo o hermano, tanto biológico como adoptado legalmente.
[25]Ser empleado de Lilly.
Para los pacientes que utilicen metformina:
[26]Tener una concentración sérica de creatinina que contraindique la utilización de metformina de acuerdo con la ficha técnica de metformina específica del país.
[27]Tener acidosis metabólica o láctica conocida.
[28]Tener cualquier enfermedad que se asocie a hipoperfusión, hipoxemia, deshidratación o sepsis.
[29]Haber sido sometido a un estudio radiológico con contraste en las 48 horas previas a su inclusión en el estudio o tener previsto realizar un estudio de este tipo o una operación durante el estudio.
[30]Durante el período entre las Visitas 1 y 2, haber tenido alguna lectura de AAGS 70 mg/dL (3,9 mmol/L) sin una causa relacionada con la dieta o la actividad o una glucosa en ayunas y un AAGS previo a la cena 140 mg/dL (7,8 mmol/L) durante 3 días consecutivos durante la semana antes de la Visita 2.

E.5 End points

E.5.1

Primary end point(s)

El estudio F3Z-MC-IOOX es uno estudio aleatorizado, multicéntrico, multinacional, abierto, de dos grupos, con control activo y diseño paralelo que utiliza ajuste de la dosis e intensificación progresiva del régimen insulínico con inyecciones adicionales de insulina. En este estudio de no inferioridad se comparará una mezcla media (MM) de insulina lispro administrada hasta tres veces al día con insulina glargina una vez al día complementada con hasta tres inyecciones de insulina lispro al día durante 36 semanas en combinación con los antidiabéticos orales (ADO) preexistentes. La aleatorización inicial a los dos grupos de tratamiento estará formada por aproximadamente 500 pacientes que en la actualidad estén recibiendo al menos dos ADO pero con un control inadecuado de la diabetes. Los pacientes de ambos grupos de tratamiento seguirán tomando sus ADO previas al estudio junto al tratamiento con insulina.
Los pacientes serán aleatorizados con estratificación (por países, según la utilización de sulfonilureas y la hemoglobina A1c [HbA1c]).
Las mediciones secundarias del estudio son comparar los tratamientos en relación con los parámetros siguientes:
•HbA1c a las 12 semanas y 24 semanas
•Porcentaje de pacientes que consiguen una HbA1c 6,5%, 7% y 7% a las 12 semanas, 24 semanas, 36 semanas y al final del estudio
•Mediciones de glucosa sanguínea (GS) a partir de los perfiles de autoanálisis de la glucosa sanguínea (AAGS) de 7 puntos a las 12 semanas, 24 semanas, 36 semanas y al final del estudio
•Dosis de insulina: dosis diaria total, dosis basal diaria y dosis prandial diaria (U/día y U/kg/día)
•Número de inyecciones al día
•Variabilidad glucémica (para este estudio se define como la desviación típica de las concentraciones de GS de un paciente procedentes del perfil de GS de 7 puntos de 1 día)
•Valor de M (GS media basada en la AAGS de 7 puntos)
Una medición exploratoria del estudio es comparar los tratamientos en relación con los AAGS de 7 puntos a las 18 y 30 semanas.
Además, para cada uno de los regímenes insulínicos finales (es decir, insulina lispro de media mezcla [MM] una vez al día, insulina lispro MM dos veces al día [MM con la comida + MM en la cena o MM en la comida + MM en la cena], insulina lispro MM tres veces al día, MM-MM-LM, glargina una vez al día, glargina + lispro una vez al día, glargina + lispro dos veces al día, glargina + lispro tres veces al día):
•Presentar el porcentaje de pacientes que recibe cada uno de los regímenes.
•Presentar los valores respectivos de HbA1c al final del estudio.
Se evaluarán las respuestas de los pacientes a los tres cuestionarios (Expectations About Insulin Therapy Questionnaire [EAITQ], Experiences With Insulin Therapy Questionnaire [EWITQ] e Insulin Device Satisfaction Questionnaire [IDSQ]) y se compararán entre los dos grupos de tratamiento.

Los investigadores son responsables de monitorizar la seguridad los pacientes incluidos en este estudio y de alertar a Lilly o a su representante sobre cualquier acontecimiento que parezca infrecuente, aun cuando se pueda considerar que este acontecimiento sea un beneficio no previsto para el paciente.
El investigador es responsable de la atención médica adecuada de los pacientes durante el estudio.
El investigador sigue siendo responsable de seguir, mediante una atención sanitaria adecuada, los acontecimientos adversos que sean graves o que hayan hecho que el paciente interrumpa el estudio antes de finalizar el estudio. Se debe seguir al paciente hasta que el acontecimiento se haya resuelto o explicado. La frecuencia de la evaluación de seguimiento queda a discreción del investigador.
Se preguntará a los pacientes sobre cualquier acontecimiento adverso en todas las visitas del estudio, incluyendo las visitas telefónicas. Además de las mediciones de seguridad standar, se evaluarán las siguientes medidas de seguridad:
•Peso: cambio del peso del paciente en kilogramos (kg) desde el valor inicial hasta el final.
•Hipoglucemia: tasa por persona por cada 30 días, además de la incidencia (número total de pacientes que experimentan hipoglucemia); hiperglucemia nocturna (y no nocturna); e incidencia de hipoglucemia grave
•Tensión arterial y frecuencia cardíaca.

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

Information not present in EudraCT

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.8.3

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.8.6 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

Information not present in EudraCT

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

Ultima visita (visita 22)

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
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 For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2006-07-31.	Yes
F.3.3.2	Women of child-bearing potential using contraception	Information not present in EudraCT
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	70
F.4.2	For a multinational trial
F.4.2.1	In the EEA	204
F.4.2.2	In the whole clinical trial	500

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

2006-10-01

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2006-07-07

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

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