Clinical Trials Register

Summary
EudraCT Number:	2013-001356-36
Sponsor's Protocol Code Number:	20131
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2013-06-20
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2013-001356-36

A.3

Full title of the trial

Effects of liraglutide or lifestyle counselling on subcutaneous adipose tissue and visceral adipose tissue distribution, circulating adipokine concentration, insulin sensitivity and beta-cell performance

Effetti di liraglutide o interventi sullo stile di vita sulla distribuzione del tessuto adiposo viscerale e sottocutaneo, la concentrazione di adipochine circolanti, la sensibilità insulinica e la performance beta-cellulare

A.3.1

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

Effects of liraglutide or lifestyle counselling on adipose tissue distribution, its production of circulating inflammatory molecules, insulin sensitivity and insulin production by pancreas

Effetti di liraglutide o consigli sullo stile di vita sulla distribuzione del tessuto adiposo, sulla produzione di molecole dell'infiammazione da parte di tale tessuto, sulla sensibilità all'insulina e sulla capacità del pancreas di produrre insulina

A.4.1

Sponsor's protocol code number

20131

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	"G. d'Annunzio" University
B.1.3.4	Country	Italy
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	"G. d'Annunzio" University Chieti, Department of Medicine and Aging
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	"G. d'Annunzio" University
B.5.2	Functional name of contact point	Department of Medicine and Aging
B.5.3	Address:
B.5.3.1	Street Address	via dei Vestini, 31
B.5.3.2	Town/ city	Chieti
B.5.3.3	Post code	66100
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390871541322
B.5.5	Fax number	+390871541261
B.5.6	E-mail	f.santilli@unich.it

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	Victoza
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	Denmark
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.4	Pharmaceutical form	Concentrate and solvent for solution for injection/infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
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	Yes
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

Obesity with a diagnosis of impaired glucose tolerance (IGT) or impaired fasting glucose (IFG) or type 2 Diabetes Mellitus (T2DM) for less than 12 months, according to the American Diabetes Association (ADA)
Guidelines

Obesità con diagnosi di alterata tolleranza glucidica (IGT) o alterata glicemia a digiuno (IFG) o diabete mellito di tipo 2 da meno di 12 mesi

E.1.1.1

Medical condition in easily understood language

Obesity with a diagnosis of prediabetes or newly diagnosed Diabetes

Obesità con diagnosi di prediabete o diabete di recente insorgenza

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	20.1
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

to assess, in obese subjects with IGT or T2DM, the separate effects of liraglutide or lifestyle counselling on SAT and VAT distribution, circulating adipokine concentration, insulin sensitivity and beta-cell performance, oxidative stress and platelet activation after a modest and
comparable weight loss (7% of initial body weight) achieved with either intervention

Valutare, in soggetti obesi con ridotta tolleranza glucidica (IGT), alterata glicemia a digiuno (IFG) o T2DM, gli effetti di liraglutide o interventi sullo stile di vita su distribuzione di VAT e SAT, concentrazione di adipochine circolanti, sensibilità insulinica, performance beta-cellulare,
stress ossidativo ed attivazione piastrinica, dopo perdita di peso modesta e confrontabile (7% del peso iniziale) realizzata con ciascun intervento

E.2.2

Secondary objectives of the trial

2. to assess, in each treatment arm, whether changes in SAT and VAT distribution after the completion of the randomized treatment may be associated with:
- modification in the release of adipokines relevant to the development of downstream complications of obesity such as T2DM and CV disease;
- changes in insulin sensitivity, as assessed by the Matsuda index, and in beta-cell performance;
- changes in oxidative stress and platelet activation.
3. to assess whether the baseline distribution of VAT and adipokine profile may be associated with baseline insulin sensitivity and beta-cell function, and whether changes in VAT/SAT ratio may predict changes in circulating adipokine concentrations, and/or changes in insulin sensitivity and/or changes in beta cell function, with either intervention.

2. Verificare, in ciascun braccio di intervento, se variazioni nel rapporto
VAT/SAT dopo la fine dello studio randomizzato possano associarsi a:
- modificazioni nel rilascio di adipochine rilevanti per lo sviluppo delle
complicanze dell'obesità, quali il T2DM e la malattia CV;
- variazioni della sensibilità insulinica, valutata con l'indice di Matsuda, e della performance beta-cellulare.
-variazioni nel grado di stress ossidativo ed attivazione piastrinica.
3. valutare se la distribuzione basale del VAT e del profilo di adipochine sia associata alla sensibilità insulinica e alla funzione della beta-cellula, e se variazioni nel rapporto VAT/SAT siano predittive di variazioni nelle concentrazioni di adipochine circolanti, e/o nella sensibilità all'insulina, e/o nella funzione beta-cellulare, con ciascun intervento.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

subjects with BMI >30, with a diagnosis of impaired glucose tolerance (IGT) or T2DM for less than 12 months, according to the American Diabetes Association (ADA) Guidelines, under diet therapy associated with metformin.

soggetti con BMI≥30, diagnosi IGT, IFG o T2DM da meno di 12 mesi, in accordo con le linee guida dell'American Diabetes Association, in trattamento con dieta associata a metformina.

E.4

Principal exclusion criteria

type 1 DM, BMI<30, DM diagnosed since >12 months, treatment with oral antidiabetic agents (except metformin) or insulin within the last three months, uncontrolled hypertension (systolic/diastolic blood pressure >160/90 mmHg), significant co-morbid diseases such as kidney disease with glomerular filtration rate below 60 ml or liver disease (AST or ALT twice above the upper normal range), pregnancy or lactation; any contraindication to liraglutide (previous pancreatitis, inflammatory bowel disease, heart failure Class NYHA III-IV).

DM tipo 1, BMI<30, diagnosi di DM da più di 12 mesi, trattamento con farmaci antidiabetici orali (eccetto metformina) o insulina negli ultimi 3 mesi, ipertensione non controllata (pressione sistolica/diastolica >160/90mmHg), significative comorbidità, quali insufficienza renale, con velocità di filtrazione glomerulare inferiore a 60 ml o epatopatia (AST o ALT> 2 volte il limite superiore della norma), gravidanza o allattamento; controindicazioni a liraglutide (pregressa pancreatite, malattia infiammatoria cronica intestinale, scompenso cardiaco di III-IV classe NYHA).

E.5 End points

E.5.1

Primary end point(s)

changes in subcutaneous and visceral fat distribution after each intervention

variazione della distribuzione del tessuto adiposo viscerale e sottocutaneo dopo ciascun intervento

E.5.1.1

Timepoint(s) of evaluation of this end point

after achievement of the weight loss goal. We anticipate to achieve the goal to lose 7% of initial body weight within 8 months (range 6 to 9 months) since the start of the randomized treatment.

dopo il raggiungimento dell'obiettivo di perdita di peso. Ci aspettiamo che l'obiettivo di perdere il 7% del peso corporeo iniziale venga raggiunto entro 8 mesi (range 6-9 mesi) dall'inizio del trattamento randomizzato

E.5.2

Secondary end point(s)

modification in the release of adipokines, in insulin sensitivity, in betacell performance, in oxidative stress and platelet activation after each intervention.

Variazioni della concentrazione di adipochine circolanti, della sensibilità all'insulina, della performance beta cellulare, dello stress ossidativo e dell'attivazione piastrinica dopo ciascun intervento

E.5.2.1

Timepoint(s) of evaluation of this end point

after achievement of the weight loss goal. We anticipate to achieve the goal to lose 7% of initial body weight within 8 months (range 6 to 9 months) since the start of the randomized treatment.

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

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

interventi sullo stile di vita

lifestyle counselling

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

ultima visita dell'ultimo soggetto arruolato nello studio

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:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

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)

usual care

secondo la pratica clinica

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

2013-09-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-10-10

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

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