Clinical Trials Register

Summary
EudraCT Number:	2020-002940-22
Sponsor's Protocol Code Number:	STARDUST
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:	2021-05-24
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

2020-002940-22

A.3

Full title of the trial

EFFECTS OF THE GLP-1 RECEPTOR AGONIST LIRAGLUTIDE ON LOWER LIMB PERFUSION IN PEOPLE WITH TYPE 2 DIABETES AND PERIPHERAL ARTERY DISEASE: A RANDOMIZED CONTROLLED TRIAL

Effetti dell’agonista recettoriale del GLP-1 liraglutide sulla perfusione degli arti inferiori in individui con diabete tipo 2 e arteriopatia periferica: un trial randomizzato controllato

A.3.1

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

EFFECTS OF THE GLP-1 RECEPTOR AGONIST LIRAGLUTIDE ON LOWER LIMB PERFUSION IN PEOPLE WITH TYPE 2 DIABETES AND PERIPHERAL ARTERY DISEASE: A RANDOMIZED CONTROLLED TRIAL

Effetti dell’agonista recettoriale del GLP-1 liraglutide sulla perfusione degli arti inferiori in individui con diabete tipo 2 e arteriopatia periferica: un trial randomizzato controllato

A.3.2

Name or abbreviated title of the trial where available

STARDUST

A.4.1

Sponsor's protocol code number

STARDUST

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	A.O.U. Università degli Studi della Campania "Luigi Vanvitelli"
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
B.4.2	Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AOU Università degli Studi della Campania "L. Vanvitelli"
B.5.2	Functional name of contact point	UOC Endocrinologia e Malattie del M
B.5.3	Address:
B.5.3.1	Street Address	Piazza miraglia, 2
B.5.3.2	Town/ city	Napoli
B.5.3.3	Post code	80138
B.5.3.4	Country	Italy
B.5.4	Telephone number	0815665289
B.5.6	E-mail	mariaida.maiorino@unicampania.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 - 6 MG/ML-SOLUZIONE INIETTABILE IN PENNA PRERIEMPITA - USO SOTTOCUTANEO - CARTUCCIA(VETRO) IN PENNA PRERIEMPITA - 3ML 2 PENNE PRERIEMPITE
D.2.1.1.2	Name of the Marketing Authorisation holder	NOVO NORDISK A/S
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	Liraglutide
D.3.2	Product code	[NA]
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	LIRAGLUTIDE
D.3.9.1	CAS number	204656-20-2
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	Secretagoghi
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	6
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
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	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

Peripheral Artery Disease and type 2 diabetes mellitus

Arteriopatia ostruttiva cronica periferica e diabete mellito tipo 2

E.1.1.1

Medical condition in easily understood language

Peripheral Artery Disease and type 2 diabetes mellitus

Arteriopatia ostruttiva cronica periferica e diabete mellito tipo 2

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10053246
E.1.2	Term	Type II diabetes peripheral angiopathy
E.1.2	System Organ Class	100000004866

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 primary objective of the STARDUST study is to evaluate the effects of liraglutide, as compared with conventional care, on the peripheral oxygen perfusion defined as transcutaneous oxygen tension of the anterior tibial artery in patients with type 2 diabetes and peripheral artery.

L’obiettivo primario dello studio STARDUST è di valutare gli effetti di liraglutide, verso cura convenzionale, sulla perfusione periferica di ossigeno, definita come tensione transcutanea di ossigeno nel territorio vascolare dell’ arteria tibiale anteriore e posteriore, mediante ossimetria transcutanea, in pazienti con diabete tipo 2 e arteriopatia periferica degli arti inferiori.

E.2.2

Secondary objectives of the trial

1. glycemic control parameters (fasting blood glucose and Hba1c, weight, body mass index, waist circumference, blood pressure)
2. lipid profile (total cholesterol, LDL-cholesterol, HDL-cholesterol and
triglycerides)
3. inflammation markers (C reactive protein, fibrinogen, TNF-a and IL-6)
4. renal function (serum creatinine, azotemia, albuminuria, glomerular filtration rate)
5. angiogenesis biomarkers (endothelial progenitors cells and vascular endothelial growth factor)
6. autonomic neuropathy (evaluation of the foot sudomotor activity)
The following parameters will also be evaluated:
7. change of sexual hormones (testosterone/estradiol, FSH, LH and SHBG)
8. change of sexual function questionnaire (International Index of Erectile Function (IIEF-5) men; Female Sexual Function Index (FSFI) for women).

- parametri di controllo glico-metabolico [glicemia a digiuno ed emoglobina glicata (HbA1c), peso, body mass index (BMI), circonferenza vita (CV), pressione arteriosa sistolica (PAS) e diastolica (PAD)];
- profilo lipidico (colesterolo totale, HDL-colesterolo, LDL-colesterolo, trigliceridi);
- markers di infiammazione [proteina C reattiva (PCR), fibrinogeno, TNF-a e interleuchina 6 (IL-6)];
- parametri di funzionalità renale [creatinina sierica, azotemia, albuminuria, velocità di filtrazione glomerulare (GFR)];
- biomarcatori di angiogenesi [progenitori delle cellule endoteliali (EPCs) e VEGF];
- indicatori clinici di aterosclerosi (indice ABI);
- ricerca di neuropatia autonomica come valutazione dell’attività sudomotoria del piede rilevata mediante cerotto NeuroPad.
- ormoni sessuali (testosterone/estradiolo, FSH, LH e SHBG);
- funzione sessuale [International Index of Erectile Function (IIEF-5) per i soggetti di sesso maschile;

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients with type 2 diabetes, peripheral artery disease with transcutaneous oxygen tension on lower limbs between 49 and 30 mmHg and with:
- HbA1c 6.5% - 8%.

pazienti con diabete tipo 2, AOCP degli arti inferiori con tensione transcutanea di ossigeno (TcPO2) compresa tra 49 e 30 mmHg e con:
- HbA1c 6.5% - 8%.

E.4

Principal exclusion criteria

Type 1 diabetes or diabetes secondary to specific causes
Previous treatment (within the last 3 months) with a GLP-1RA or a DPP-4 inhibitor
Contraindications to the use of GLP-1RA (pancreatitis)
Pregnancy or pregnancy scheduled during the study period
Planned vascular revascularization
GFR <15 ml/min
History of cancer or anti-neoplastic therapy in the 5 years prior to randomization
Current therapy with oral, topical or systemic glucocorticoids, or with atypical antipsychotics.

diabete tipo 1 o diabete secondario a cause specifiche;
trattamento corrente o recente (negli ultimi 3 mesi) con un GLP-1RA o un DPP-4 inibitore;
controindicazioni all’utilizzo di GLP-1RA (pancreatite);
gravidanza o gravidanza programmata nel periodo di tempo dello studio;
pianificazione di una procedura di rivascolarizzazione coronarica, carotidea o dell’albero arterioso periferico;
eGFR < 15 ml/min;
storia di cancro o di terapia anti-neoplastica nei 5 anni precedenti la randomizzazione;
terapia corrente con glucocorticoidi per via orale, topica o sistemica, o con anti-psicotici atipici;
presenza di qualsiasi condizione clinica, psicologica o psichiatrica che, secondo il parere dello sperimentatore, rende incompatibile la partecipazione allo studio

E.5 End points

E.5.1

Primary end point(s)

Variation of TcPO2 levels on lower limbs intended as an increase of 10% in the liraglutide group compared to the levels measured at baseline.

Variazione del 10% della TcPO2 nel gruppo di pazienti trattati con liraglutide rispetto ai pazienti del gruppo di controllo dopo sei mesi dall’inizio dell’intervento. La variazione della TcPO2, determinata mediante ossimetria transcutanea, verrà definita dalla differenza fra i valori di TcPO2 misurati alla visita basale e alla visita di fine studio.

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 mesi

E.5.2

Secondary end point(s)

Variation of:
1. glycemic control parameters (fasting blood glucose and Hba1c, weight, body mass index, waist circumference, blood pressure)
2. lipid structure (total cholesterol, LDL-cholesterol, HDL-cholesterol and
triglycerides)
3. inflammation markers (C reactive protein, fibrinogen, TNF-a and IL-6)
4. renal function (serum creatinine, azotemia, albuminuria, glomerular filtration rate)
5. angiogenesis biomarkers (Endothelial Progenitors Cells and vascular endothelial growth factor)
6. autonomic neuropathy (evaluation of the foot sudomotor activity)
The following changes will also be evaluated:
7. sexual hormones (testosterone/estradiol, FSH, LH and SHBG)
8. sexual function questionnaire (International Index of Erectile Function (IIEF-5) men; Female Sexual Function Index (FSFI) for women).

Variazioni di:
- parametri di controllo glico-metabolico [glicemia a digiuno ed emoglobina glicata (HbA1c), peso, body mass index (BMI), circonferenza vita (CV), pressione arteriosa sistolica (PAS) e diastolica (PAD)];
- profilo lipidico (colesterolo totale, HDL-colesterolo, LDL-colesterolo, trigliceridi);
- markers di infiammazione [proteina C reattiva (PCR), fibrinogeno, TNF-a e interleuchina 6 (IL-6)];
- parametri di funzionalità renale [creatinina sierica, azotemia, albuminuria, velocità di filtrazione glomerulare (GFR)];
- biomarcatori di angiogenesi [progenitori delle cellule endoteliali (EPCs) e VEGF];
- indicatori clinici di aterosclerosi (indice ABI);
- ricerca di neuropatia autonomica come valutazione dell’attività sudomotoria del piede rilevata mediante cerotto NeuroPad.
Verranno, altresì, valutati i riscontri basali e le variazioni di:
- ormoni sessuali (testosterone/estradiolo, FSH, LH e SHBG);
- funzione sessuale [International Index of Erectile Function (IIEF-5) per i soggetti di sesso maschile; Female Sexual Function Index (FSFI) per i soggetti di sesso femminile].

E.5.2.1

Timepoint(s) of evaluation of this end point

6 months

6 mesi

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

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

cura convenzionale

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

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

Information not present in EudraCT

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

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

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Outpatient clinical checks according to routine clinical practice with planned visits every 3 months

Controlli clinici ambulatoriali secondo pratica clinica di routine con controlli pianificati ogni 3 mesi

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

2021-01-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-01-13

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

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