Clinical Trials Register

Summary
EudraCT Number:	2015-003954-42
Sponsor's Protocol Code Number:	FPS-INSUPAR-2015-01
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:	2015-10-30
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2015-003954-42

A.3

Full title of the trial

Subcutaneous versus intravenous basal insulin in non-critical hospitalized diabetic patients receiving total parenteral nutrition

Insulina basal subcutánea versus intravenosa en pacientes diabéticos hospitalizados no críticos que reciben nutrición parenteral total

A.3.1

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

Comparison of the use of insulin by injection under the skin versus insulin by injection directly into a vein, in patients suffering diabetes, who are hospitalized but not in critical conditions, and who are receiving food completely by introducing it in a vein (total parenteral nutrition)

Comparación del uso de insulina en forma de inyección bajo la piel frente a insulina en forma de inyección directamente en vena, en pacientes que sufran diabetes, que se encuentren hospitalizados en estado no crítico, y que estén recibiendo alimento completamente por introducción en vena (nutrición parenteral total)

A.4.1

Sponsor's protocol code number

FPS-INSUPAR-2015-01

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	Fundación Pública Andaluza Progreso y Salud
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Fundación Pública Andaluza Progreso y Salud
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fundación Pública Andaluza Progreso y Salud
B.5.2	Functional name of contact point	Unidad de Apoyo a Ensayos Clínicos
B.5.3	Address:
B.5.3.1	Street Address	Avda. Américo Vespucio 5, B2, 2ª planta
B.5.3.2	Town/ city	Sevilla
B.5.3.3	Post code	41092
B.5.3.4	Country	Spain
B.5.4	Telephone number	34955040450
B.5.5	Fax number	34955040457
B.5.6	E-mail	gestionensayosclinicos.fps@juntadeandalucia.es

D. IMP Identification
D.IMP: 1
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	Actrapid 100 IU/ml injectable solution
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.3.1	Product name	insulin (human)
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	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INSULIN HUMAN
D.3.9.1	CAS number	11061-68-0
D.3.9.2	Current sponsor code	insulin regular
D.3.9.4	EV Substance Code	SUB08197MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/kg international unit(s)/kilogram
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.3 to 0.5
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	No
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	Lantus 100 IU/ml injectable solution
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.3.1	Product name	Insulin glargine
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.3.9.2	Current sponsor code	insulin glargine
D.3.9.4	EV Substance Code	SUB08196MIG
D.3.10	Strength
D.3.10.1	Concentration unit	IU/kg international unit(s)/kilogram
D.3.10.2	Concentration type	range
D.3.10.3	Concentration number	0.3 to 0.5
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	No
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 (DM) is a group of metabolic disorders that causes high levels of blood glucose (hyperglycemia) which are persistent or chronic. DM presents epidemic proportions in most of the world. In Spain, the estimated prevalence of DM reaches 14% of the adult population. The prevalence of DM in the hospitals is also very high and is associated with increased mortality during hospitalization, longer hospital stays and higher costs.

Diabetes mellitus (DM) es un grupo de trastornos metabólicos que provoca altos niveles de glucosa en sangre (hiperglucemia) que son persistente o crónica. DM presenta proporciones epidémicas en la mayor parte del mundo. En España, la prevalencia estimada de DM alcanza el 14% de la población adulta. La prevalencia de DM en los hospitales también es muy alta y se asocia con una mayor mortalidad durante la hospitalización, estancias hospitalarias más largas y mayores costos.

E.1.1.1

Medical condition in easily understood language

Diabetes mellitus (DM) is a group of metabolic disorders that causes high levels of blood glucose (hyperglycemia) which are persistent or chronic.

Diabetes mellitus (DM) es un grupo de trastornos metabólicos que provoca altos niveles de glucosa en sangre (hiperglucemia) que son persistente o crónica.

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	18.1
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

Analyze the degree of metabolic control achieved by a pattern of regular insulin in the stock of parenteral nutrition (PN) plus glargine subcutaneous insulin, compared to regular insulin in the stock of PN.

Analizar el grado de control metabólico alcanzado de una pauta de insulina regular en la bolsa de nutrición parenteral (NP) más insulina glargina subcutánea, frente a insulina regular en la bolsa de NP.

E.2.2

Secondary objectives of the trial

1. Compare parameters of glycemic control during total parenteral nutrition (TPN) between the two guidelines:
- Rapid glucose average.
- Percentage of patients with average capillary blood glucose <180 mg/dL.
- Glycemic variability.
- Hypoglycemia.

2. Evaluate the average stay, complications and in-hospital mortality by insulin pattern and degree of metabolic control achieved.

3. Validate the utility of new glucose monitoring device Freestyle Free for management of hyperglycemia in diabetic patients with TPN.

4. Create a biobank of biological samples (blood) diabetes patients receiving TPN for further studies related to metabolism, inflammation, oxidation.

1. Comparar los parámetros de control glucémico durante la nutrición parenteral total (NPT) entre las dos pautas:
- Glucemia capilar media.
- Porcentaje de pacientes con valores de glucemia capilar media <180 mg/dL.
- Variabilidad glucémica.
- Hipoglucemias.

2. Valorar la estancia media, complicaciones y mortalidad intrahospitalaria en función de la pauta insulínica y grado de control metabólico alcanzado.

3. Validar la utilidad del nuevo dispositivo de monitorización de glucosa Freestyle Libre para el manejo de la hiperglucemia en pacientes diabéticos con NPT.

4. Crear un biobanco de muestras biológicas (sangre) de pacientes con diabetes que reciben NPT para ulteriores estudios relacionados con el metabolismo, inflamación, oxidación.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Adults (> 18 years).
- Previously diagnosed with diabetes mellitus.
- Hospitalized without intensive cares.
- Having indication of total parenteral nutritional support (TPN, covering over 70% of the nutritional daily requirements via parenteral way of administration) and it is specified that it will be needed for a minimum of 5 days.
- Read and signature of informed consent.

- Adultos (>18 años).
- Diagnosticados previamente de diabetes mellitus.
- Ingresados en planta de hospitalización no de cuidados intensivos.
- Que tengan indicación de soporte nutricional parenteral total (NPT), entendiéndose como tal la que cubra más del 70% de los requerimientos estimados diarios por vía parenteral) y se prevea que la precisarán durante un mínimo de 5 días.
- Firma del consentimiento informado.

E.4

Principal exclusion criteria

Diabetes mellitus type 1, diabetes secondary to total pancreatectomy.
- Patients in intensive care.
- Patients who have been prescribed total parenteral nutrition in intensive cares more than 48 hours prior to admission for hospitalization.
- Intradialytic parenteral nutrition.
- Patients under 18 or pregnant women.
- Patients with renal insufficiency stage 3 B (glomerular filtration rate <45 mL / min)

- Diabetes mellitus tipo 1, diabetes secundaria a pancreatectomía total.
- Pacientes de cuidados intensivos.
- Pacientes a los que se les haya prescrito la nutrición parenteral total en la unidad de cuidados intensivos en un plazo superior a las 48 horas previas al ingreso en la planta de hospitalización.
- Nutrición parenteral intradialítica.
- Pacientes menores de 18 años o gestantes.
- Pacientes con insuficiencia renal estadío 3 B (filtrado glomerular < 45 mL/min).

E.5 End points

E.5.1

Primary end point(s)

Efficacy endpoints:
- Blood glucose
- Interstitial glucose
- Glycemic variability

Variables de eficacia:
- Glucosa capilar
- Glucosa intersticial
- Variabilidad glucémica

E.5.1.1

Timepoint(s) of evaluation of this end point

From the first day of the TPN, every 6 hours, during 10 days.

Desde el primer día de la TPN, cada 6 horas, durante 15 días.

E.5.2

Secondary end point(s)

Security endpoints:
- Infections related with parenteral nutrition catheter
- Metabolic complications
- Liver complications
- Adverse Events

Variables de seguridad:
- Infecciones relacionadas con el catéter de nutrición parenteral
- Complicaciones metabólicas
- Complicaciones hepáticas
- Eventos adversos

E.5.2.1

Timepoint(s) of evaluation of this end point

Periodically

Periódicamente

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

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

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.8.2.4

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

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

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

1. Presence of a serious adverse event from the inclusion of the patient.
2. Clinical conditions of the patient that prevent the continuation of the TPN.
3. This reasons: the patient does not cooperate or does not meet the requirements of the study; the duration of the TPN is less than 5 days; the investigator believes that the patient's health is compromised; abnormal result of exploration procedures; serious deviation from protocol; withdrawal of consent by the patient or loss of follow-up.

1. Presencia de acontecimiento adverso grave.
2. Condiciones clínicas del paciente que impidan la continuidad de la NPT.
3. Siguientes razones: El paciente no coopere o no cumpla los requerimientos del estudio; la duración de la NPT sea inferior a 5 días; el investigador considere que la salud del paciente está comprometida; resultados anormales de los procedimientos exploratorios; desviación grave del protocolo; retirada del consentimiento por parte del paciente o pérdida de seguimiento.

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

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:

320

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

320

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

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

320

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

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

2016-01-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2016-01-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2018-04-03

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials