Clinical Trials Register

Summary
EudraCT Number:	2011-006352-36
Sponsor's Protocol Code Number:	VPN-10-18
National Competent Authority:	Lithuania - SMCA
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-01-14
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

Lithuania - SMCA

A.2

EudraCT number

2011-006352-36

A.3

Full title of the trial

Obesity in children and adolescents: complications, associated risks and early intervention (lifestyle changes and insulin sensitivity improving medicine (metformin) effectiveness and safety evaluation)

Vaikų ir paauglių nutukimas: pasekmės, rizikos ir ankstyva intervencija (gyvenimo būdo keitimo ir insulino jautrumą gerinančio preparato (metformino) veiksmingumo ir saugumo įvertinimas)

A.3.1

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

Metformin, diet and physical activity influence on the overweight and obesity in children

Metformino, dietos ir fizinio aktyvumo įtaka vaikų antsvoriui bei nutukimui.

A.3.2

Name or abbreviated title of the trial where available

OCA

VPN

A.4.1

Sponsor's protocol code number

VPN-10-18

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	Lithuanian University of Health Sciences, Endocrinology Department
B.1.3.4	Country	Lithuania
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	Lithuanian University of Health Sciences
B.4.2	Country	Lithuania
B.4.1	Name of organisation providing support	Lithuanian Association of pediatric endocrinologists
B.4.2	Country	Lithuania
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Lithuanian University of Health Sciences, Endocrinology Department
B.5.2	Functional name of contact point	Rasa Verkauskiene
B.5.3	Address:
B.5.3.1	Street Address	Eiveniu str. 2
B.5.3.2	Town/ city	Kaunas
B.5.3.3	Post code	LT-50009
B.5.3.4	Country	Lithuania
B.5.4	Telephone number	37037326816
B.5.5	Fax number	37037326816
B.5.6	E-mail	rasa.verkauskiene@kaunoklinikos.lt

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	Metforal 500 mg / tablet
D.2.1.1.2	Name of the Marketing Authorisation holder	Berline-Chemie (Menarini group)
D.2.1.2	Country which granted the Marketing Authorisation	Germany
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Metforal
D.3.2	Product code	LT/1/2000/1230/003
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
D.3.9.1	CAS number	657-24-9
D.3.9.3	Other descriptive name	Metforal
D.3.9.4	EV Substance Code	SUB08831MIG
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

The aim of our study is to establish the effectivenes and safety of metformin use in pediatric obese population; to assess the prevalence of insulin resistance, metabolic syndrome, polycystic ovary syndrome (PCOS), impaired glucose tolerance (IGT) and type 2 diabetes mellitus (T2DM) among overweight and obese children and adolescents in Lithuania, and to determine the effect of targeted interventions (lifestyle and metformin) in controlling obesity and associated diseases risk.

Tyrimo tikslas yra nustatyti metformino veiksmingumą bei saugumą skiriant jį nutukusiems vaikams, taip pat įvertinti atsparumo insulinui, metabolinio sindromo, policistinių kiaušidžių sindromo (PKS), gliukozės toleravimo sutrikimo bei 2 tipo diabeto paplitimą tarp antsvorį bei nutukimą turinčių vaikų ir paauglių Lietuvoje, bei apibrėžti tikslinės intervencijos (gyvenimo būdo keitimo bei metformino) įtaką kontroliuojant nutukimą ir su juo susijusių ligų riziką.

E.1.1.1

Medical condition in easily understood language

Metformin, diet and physical activity influence on the pediatric obesity and related metabolic and hormonal disturbances.

Metformino, dietos bei fizinio aktyvumo įtaka vaikų nutukimui ir jo sąlygotiems metaboliniams bei hormonų sutrikimams.

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	PT
E.1.2	Classification code	10029883
E.1.2	Term	Obesity
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	PT
E.1.2	Classification code	10033307
E.1.2	Term	Overweight
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

The main aim of our study is to investigate metformin influence on BMI in obese children

Pagrindinis mūsų tyrimo tikslas yra įvertinti metformino įtaką nutukusių vaikų KMI

E.2.2

Secondary objectives of the trial

Other aims of our study are to establish metformin efficacy and safety for pediatric obesity treatment; to evaluate the metformin, physical activity and diet influence on weight, hormone, glucose and lipid profiles, insulin sensitivity, metabolic complications risks.

Kiti mūsų tyrimo tikslai yra nustatyti metformino veiksmingumą bei saugumą gydant nutukusius vaikus, įvertinti metformino, fizinio aktyvumo bei dietos įtaką svoriui, hormonų, gliukozės bei lipidų profiliams, insulino jautrumui bei metabolinių komplikacijų rizikoms.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Age 10-17 yrs;
• BMI > 85th percentile for age and gender (by IOTF);
• Living in Kaunas and its region;
• No obvious chronic diseases;
• Not on long-term steroid oral / IV treatment;
• Childbearing age ladies using contraception;
• Informed consent of the patient and parents (official caregivers);

• Amžius 10-17 metų;
• KMI >85-os procentilės pagal amžių ir lytį (pagal IOTF kriterijus);
• Gyvena Kauno mieste ar rajone;
• Nėra nustatytų lėtinių ligų;
• Nėra ilgalaikio peroralinio ar intraveninio gydymo gliukokortikoidais;
• Vaisingo amžiaus panelės, vartojančios kontracepciją;
• Paciento ar jo tėvų (globėjų) pasirašytas sutikimas tyrimui

E.4

Principal exclusion criteria

• Age less than 10 or above 17 yrs;
• Diagnosis of type 1 diabetes;
• Chronic illness that may affect physical activity, hormone and metabolic profile;
• Insulin treatment;
• Steroid treatment;
• Planning to move from Kaunas or its region in the period of 1 year;
• Childbearing age ladies non- using contraception, pregnancy planning;
• Protocol refused by the patient or his parents;

Amžius <10 arba >17 metų;
• 1 tipo cukrinis diabetas;
• Lėtinis ligos, kurios gali paveikti fizinį aktyvumą, hormonų bei metabolinį profilį;
• Gydymas insulinu;
• Gydymas gliukokortikoidais;
• Planuojamas išvykimas iš Kauno miesto ar rajono metų eigoje;
• Vaisingo amžiaus panelės, nevartojančios kontracepciją, planuojamas nėštumas;
• Paciento ar jo tėvų (globėjų) atsisakymas pasirašyti sutikimą klinikiniam tyrimui

E.5 End points

E.5.1

Primary end point(s)

BMI decrease;

KMI sumažėjimas;

E.5.1.1

Timepoint(s) of evaluation of this end point

The timepoint of the evaluation is 12 months

Vertinimas po 12 mėnesių

E.5.2

Secondary end point(s)

weight, circumferences, skin folds decrease;
glucose, insulin and HOMA-IR decrease ;
hormone and lipid profile improvment

svorio, kūno apimčių, odos riebalinių klosčių storio sumažėjimas;
gliukozės, insulino bei HOMA-IR sumažėjimas;
hormonų bei riebalų profilio pagerėjimas

E.5.2.1

Timepoint(s) of evaluation of this end point

12 months

12 mėnesių

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

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

E.8.1.5

Parallel group

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Nemedikamentinė intervencija (fizinis aktyvumas ir dieta)

Non-medicine intervention (physical activity and diet)

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.8.5

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

LVLS

Paskutinio įtraukto tiriamojo paskutinis vizitas

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

Yes

F.1.1

Number of subjects for this age range:

100

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:

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

100

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)

Standard treatment: recommendation on physical activity and diet

Standartinis gydymas rekomenduojant fizinį aktyvumą bei dietą

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

2013-04-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-03-22

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-09-01

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