Clinical Trials Register

Summary
EudraCT Number:	2013-001003-36
Sponsor's Protocol Code Number:	MCCPTAN2012-60
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2021-01-21
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2013-001003-36

A.3

Full title of the trial

The DIAMOND® for the Treatment of Type 2 Diabetes: Can blood Triglycerides level be the predictor for therapy efficiency?

Il DIAMOND per il trattamento del diabete tipo 2: può il livello dei trigliceridi nel sangue essere un indicatore dell'efficienza della terapia?

A.3.1

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

DIAMOND device to evaluate the blood Triglycerides level level in patients with type 2 diabetes.

Dispositivo DIAMOND per valutare il livello di trigliceridi nel sangue in pazienti diabetici di tipo 2.

A.3.2

Name or abbreviated title of the trial where available

DIAMOND

A.4.1

Sponsor's protocol code number

MCCPTAN2012-60

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	METACURE LIMITED
B.1.3.4	Country	Bermuda
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	METACURE LIMITED
B.4.2	Country	Bermuda
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	L.N.Age srl
B.5.2	Functional name of contact point	CRO
B.5.3	Address:
B.5.3.1	Street Address	via Luigi Rizzo 62
B.5.3.2	Town/ city	Roma
B.5.3.3	Post code	00136
B.5.3.4	Country	Italy
B.5.4	Telephone number	0639746749
B.5.5	Fax number	0683962771
B.5.6	E-mail	paolo.ferrazza@lnage.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	FULCROSUPRA 160 mg
D.2.1.1.2	Name of the Marketing Authorisation holder	BGP PRODUCTS SRL
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Film-coated 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	FENOFIBRATO
D.3.9.1	CAS number	49562-28-9
D.3.9.2	Current sponsor code	60-10
D.3.9.3	Other descriptive name	fenofibrate
D.3.9.4	EV Substance Code	SUB07576MIG
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	160
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	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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
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

diabetes type 2

diabete di tipo 2

E.1.1.1

Medical condition in easily understood language

diabetes type 2

diabete di tipo 2

E.1.1.2

Therapeutic area

Body processes [G] - Physiological processes [G07]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.0
E.1.2	Level	LLT
E.1.2	Classification code	10012659
E.1.2	Term	Diabetic control impaired
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

The main objectives of this study are to evaluate the
efficacy of gastric stimulation (GCM) using the DIAMOND System in the improvement of glycemic control measured by changes in HbA1c and the relationship between blood TG level and the GCM efficacy.

Il principale obiettivo dello studio è di valutare l’efficacia della stimolazione gastrica (GCM), erogata dal sistema DIAMOND, nel miglioramento del controllo glicemico, misurato dai cambiamenti dell’emoglobina glicata (HbA1c) e la relazione con il livello dei trigliceridi (TG) nel sangue.

E.2.2

Secondary objectives of the trial

The effects of GCM on weight loss and associated co-morbid conditions will also be evaluated.

Vengono valutati gli effetti della GCM sulla perdita di peso e sulle condizioni delle comorbidità associate.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Subjects 18 through 70 years of age, overweight and obese, Type 2 diabetes, with a body mass index (BMI) of 30 to 45 (kg/m2) and poor glycemic control defined as HbA1c = 7.3% and = 9.5% and fasting blood glucose (FBG) between 120-350 mg/dL.

Soggetti con età compresa tra 18 e 70 anni, con diabete tipo 2 sovrappeso e obesi con indice di massa corporea (BMI) tra 30 e 45 (kg/m2) e scarso controllo glicemico definito da una HbA1c = 7.3% e = 9.5% e un livello di glucosio nel sangue a digiuno (FBG) tra 120-350 mg/dL.

E.4

Principal exclusion criteria

Insulin therapy in last 3 months; Taking GLP-1 agonists or in the last 3 months before the enrollment; Currently taking fibrates, nicotinamide and omega 3 fatty acids as antilipidemic treatment; any condition(s) for which it is contraindicated the possible intake of fenofibrate.

Terapia insulinica negli ultimi 3 mesi; somministrazione di GLP-1-agonisti negli ultimi 3 mesi prima dell'arruolamento; terapia con fibrati, nicotinamide e acidi grassi di omega 3 come trattamento ipolipidemizzante; condizioni per le quali è controindicato l'assunzione di fenofibrato.

E.5 End points

E.5.1

Primary end point(s)

Comparison of the differences in HbA1c levels between baseline before the implantation and 12 months post-implant for:
- Low blood TG patients;
- High blood TG patients;
- High blood TG patients treated with blood TG
lowering therapy concomitant with GCM therapy.

Confronto delle differenze nei livelli di HbA1c alla baseline prima dell’impianto e a 12 mesi dopo l’impianto per:
-soggetti con basso livello di TG nel sangue;
-soggetti con alto livello di TG nel sangue;
-soggetti con alto livello di TG nel sangue trattati con
terapia per il controllo del livello dei TG nel sangue in
concomitanza con la terapia GCM.

E.5.1.1

Timepoint(s) of evaluation of this end point

13 months

13 mesi

E.5.2

Secondary end point(s)

Trends in weight loss will be of a reduction in weight
during treatment in 3 patient groups; Trends in Meal Tolerance Test profile between baseline and 12 months post-implant for 3 patient groups; Trends in improvement in metabolic parameters such as waist circumference, blood pressure and lipids 3 patient
groups.

Andamento della perdita di peso durante il trattamento per i 3 gruppi di pazienti; andamento del profilo del test di tolleranza ai pasti (MTT) alla baseline e a 12 mesi dall’impianto per i 3 gruppi di
pazienti; andamento nel miglioramento dei parametri metabolici come la circonferenza della vita, la pressione sanguigna e i lipidi nei 3 gruppi di pazienti.

E.5.2.1

Timepoint(s) of evaluation of this end point

13 months

13 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

E.8.1.2

Open

E.8.1.3

Single blind

Yes

E.8.1.4

Double blind

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

semi-randomizzato

semi-randomized

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

Information not present in EudraCT

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

Australia

Serbia

Austria

Greece

Italy

Poland

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

After the last scheduled visit (week 48), subjects will be offered to keep the device. A post monitoring period of one year will follow (see protocol). Subjects willing to keep the device will be issued a new device warranty and turned over to their investigator to monitor as appropriate for their diabetes. Patients from the "HTG + placebo" might
be offered fenofibrate treatment if found appropriate for the increase of GCM therapy efficiency. Any explant will be on behalf of the sponsor.

Dopo l'ultima visita programmata (settimana 48), ai soggetti verrà offerto di tenere il dispositivo e seguirà un periodo di monitoraggio di un anno. Ai soggetti disposti a tenere il dispositivo verrà rilasciato un nuovo certificato di garanzia del dispositivo stesso e potranno continuare a essere seguiti dallo sperimentatore per il controllo del diabete. I pazienti del gruppo "HTG + placebo" potrebbero successivamente seguire un trattamento con fenofibrato se ritenuto appropriato per migliorare

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

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

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)

After the last scheduled visit (week 48), subjects will be offered to keep the device. Follow a period of one year of monitoring. Subjects that want to keep the device will receive a new device warranty and they will be followed by investigators to monitor as appropriate for their diabetes. Patients from the "HTG + placebo" might be offered fenofibrate treatment if found appropriate for the increase of GCM therapy efficiency. Any explant will be on behalf of the sponsor.

Dopo l'ultima visita programmata (settimana 48), ai soggetti sarà offerto di tenere il dispositivo. Seguirà un periodo di monitoraggio di un anno. Ai soggetti disposti a mantenere il dispositivo verrà rilasciato una nuova garanzia del dispositivo stesso e saranno seguiti dal proprio medico che terrà sotto controllo il loro diabete. Ai pazienti del "HTG + placebo" sarà proposto anche un trattamento con fenofibrato, se considerato appropriato per una migliore efficienza della terapia associata al

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

2016-02-05

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-08

P. End of Trial
P.	End of Trial Status	Completed

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