Clinical Trials Register

Summary
EudraCT Number:	2011-002528-42
Sponsor's Protocol Code Number:	0431-083
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2011-12-21
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

2011-002528-42

A.3

Full title of the trial

A Phase III, Multicenter, Double-Blind, Randomized, Placebo- and Metformin-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Sitagliptin in Pediatric Patients with Type 2 Diabetes Mellitus with Inadequate Glycemic Control

Ensayo clínico de fase III multicéntrico, aleatorizado, doble ciego y controlado con placebo y metformina de evaluación de la seguridad y la eficacia de sitagliptina en pacientes pediátricos con diabetes mellitus de tipo 2 y un control insuficiente de la glucemia

A.3.1

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

A Study of Sitagliptin in Pediatric Patients with Type 2 Diabetes Mellitus

Ensayo de Sitagliptina en pacientes pediátricos con DM tipo II

A.3.2

Name or abbreviated title of the trial where available

Sitagliptin Ped. Pts. Type 2 Diab. Mellitus Inadequate Glycemic Control

Sitagliptina en pacientes pediátricos con DMII con un control insuficiente de glucemia

A.4.1

Sponsor's protocol code number

0431-083

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Merck Sharp & Dhome Corp., a subsidiary of Merck & Co., Inc (hereafter referred to as Sopnsor or Merck)
B.1.3.4	Country	United States
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	Merck Sharp & Dohme Corp.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Merck Sharp & Dhome Corp., a subsidiary of Merck & Co., Inc (hereafter referred to as Sopnsor or Merck)
B.5.2	Functional name of contact point	Ravi
B.5.3	Address:
B.5.3.1	Street Address	126 E. Lincoln Avenue, PO Box 2000
B.5.3.2	Town/ city	Rahway
B.5.3.3	Post code	07065-0900
B.5.3.4	Country	United States
B.5.4	Telephone number	7325943046NA
B.5.5	Fax number	7325943046NA
B.5.6	E-mail	ravi_shankar@merck.com

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	JANUVIA
D.2.1.1.2	Name of the Marketing Authorisation holder	MERCK SHARP & DOHME LIMITED
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	MK-0431
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	sitagliptin phosphate
D.3.9.1	CAS number	654671-78-0
D.3.9.3	Other descriptive name	SITAGLIPTIN PHOSPHATE
D.3.9.4	EV Substance Code	SUB25200
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
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	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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	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	Metformin
D.2.1.1.2	Name of the Marketing Authorisation holder	Aurobindo Pharma Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	PR2
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	METFORMIN HYDROCHLORIDE
D.3.9.1	CAS number	1115-70-4
D.3.9.3	Other descriptive name	metformin hydrochloride
D.3.9.4	EV Substance Code	SUB03200MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Type 2 Diabetes Mellitus

Diabetes Mellitus tipo II

E.1.1.1

Medical condition in easily understood language

Diabetes Type 2

Diabetes tipo II

E.1.1.2

Therapeutic area

Diseases [C] - Hormonal diseases [C19]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10012594
E.1.2	Term	Diabetes
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
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	10027433 - Metabolism and nutrition disorders

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

In pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control: (1) after 16 weeks, to assess the effect of treatment with sitagliptin compared with placebo on A1C (2) to assess the safety and tolerability of sitagliptin

En pacientes pediátricos (10 17 años de edad) con DMT2 con un control insuficiente de la glucemia:
1. Objetivo: Después de 16 semanas, evaluar el efecto del tratamiento con sitagliptina sobre la A1C, en comparación con placebo.
Hipótesis: La sitagliptina produce una reducción de la A1C mayor que la observada con placebo tras 16 semanas de tratamiento.
2. Objetivo: Evaluar la seguridad y la tolerabilidad de la sitagliptina.

E.2.2

Secondary objectives of the trial

In pediatric patients (ages 10-17 years) with T2DM with inadequate glycemic control, after 16 weeks (1) to assess the effect of treatment with sitagliptin compared with placebo on fasting plasma glucose (FPG) (2) to assess the effect of treatment with sitagliptin compared with placebo on the proportion of patients requiring glycemic rescue

En pacientes pediátricos (10 17 años de edad) con DMT2 con un control insuficiente de la glucemia tras 16 semanas de tratamiento:
1. Objetivo: Determinar el efecto del tratamiento con sitagliptina en comparación con placebo sobre la glucemia en ayunas (GA).
2. Objetivo: Evaluar el efecto del tratamiento con sitagliptina en comparación con placebo sobre la proporción de pacientes que precisan tratamiento de rescate glucémico.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patient has type 2 diabetes mellitus (T2DM).
2. Patient has not treatment with an oral AHA for ?12 weeks prior to the Screening Visit/Visit 1, or with insulin for at least 6 months prior to the Screening Visit/Visit 1.
3. Patient has an A1C ?7.0% and ?10.0%.
4. Patient is 10 and 17 years of age on day of signing informed consent with randomization to occur prior to the patient?s 18th birthday.
5. Patient is either a male, or patient is a female who is unlikely to conceive as indicated by at least one ?yes? response to the following which will remain consistent for the projected duration of the study and for 14 days after the last dose of study medication: (a) Patient is a non-sterilized female who is currently not sexually active and agrees to follow statement "c" if heterosexual activity is initiated or (b) Patient agrees to abstain from heterosexual activity or (c) Patient agrees to use an adequate method of contraception.

1. El paciente tiene DMT2
2. El paciente no ha recibido tratamiento con un AD oral durante al menos las 12 semanas previas a la visita de selección/visita 1 ni con insulina durante al menos los 6 meses previos a la visita de selección/visita 1
3. El paciente presenta una A1C ?7,0 % y ?10,0 %.
4. El paciente tiene de 10 a 17 años de edad el día de la firma del consentimiento informado y la aleatorización deberá tener lugar antes de que el paciente cumpla 18 años.
5. El paciente es de sexo masculino, o de sexo femenino con pocas probabilidades de concebir, lo que se determina por al menos una respuesta afirmativa a los puntos siguientes, que se mantendrá invariable durante todo el período previsto del estudio y hasta 14 días después de la última dosis de la medicación del estudio:
a)Paciente de sexo femenino no esterilizada que en la actualidad no tiene actividad sexual y se compromete a cumplir el punto ?c? en caso de iniciar relaciones heterosexuales o bien
b) Paciente que acepta abstenerse de mantener relaciones sexuales
c) Paciente que acepta utilizar un método anticonceptivo adecuado.

E.4

Principal exclusion criteria

1. Patient has diabetes for >1 year.
2. Patient has (1) a history of type 1 diabetes mellitus, autoimmune diabetes mellitus or has a positive antibody screen for anti-GAD or ICA-512, or (2) known monogenic diabetes, secondary diabetes, or a genetic syndrome or disorder known to affect glucose tolerance other than diabetes
3. Patient has symptomatic hyperglycemia and/or moderate to large ketonuria requiring immediate initiation of antihyperglycemic therapy.

1. El paciente ha tenido diabetes durante >1 año.
2. El paciente tiene antecedentes de diabetes mellitus de tipo 1, diabetes mellitus autoinmune o es positivo en las pruebas de anticuerpos anti GAD o ICA 512.
3. El paciente tiene diabetes monogénica, diabetes secundaria o un síndrome o trastorno genético distinto de la diabetes cuya influencia sobre la tolerancia a la glucosa es conocida.
4. El paciente presenta hiperglucemia sintomática y/o cetonuria de moderada a marcada que exigen la instauración inmediata de un tratamiento antihiperglucémico.

E.5 End points

E.5.1

Primary end point(s)

hemoglobin A1c (A1C)

Hemoglobina A1c (A1c)

E.5.1.1

Timepoint(s) of evaluation of this end point

16 weeks

16 semanas

E.5.2

Secondary end point(s)

fasting plasma glucose (FPG)

Gucosa plasmática en ayunas

E.5.2.1

Timepoint(s) of evaluation of this end point

16 weeks

16 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

Yes

E.6.11

Pharmacogenomic

Yes

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)

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

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

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)

E.8.2.2

Placebo

Yes

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

Yes

E.8.4

The trial involves multiple sites in the Member State concerned

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Argentina

Bulgaria

Chile

China

Colombia

Costa Rica

Dominican Republic

Ecuador

Guatemala

India

Israel

Italy

Latvia

Lithuania

Malaysia

Mexico

Romania

Russian Federation

Singapore

Thailand

United Kingdom

E.8.7

Trial has a data monitoring committee

Yes

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

LVLS

ültimo paciente última visita

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

Number of subjects for this age range:

360

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

345

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

Yes

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Pediatric patients 10-17 years old.

Pacientes de 10-17 años

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

360

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)

After the patient has discontinued study medication, the patient will receive the usual standard of care administered through the patient's primary care physician and diabetologist.

Una vez que el paciente haya discontinuado la medicación del estudio, el paciente recibirá la medicación habitualadministrada bien por su médico de atención primaria o endocrino.

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2012-04-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-02

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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