Clinical Trials Register

Summary
EudraCT Number:	2016-004889-26
Sponsor's Protocol Code Number:	EFC14837
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:	2020-11-05
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

2016-004889-26

A.3

Full title of the trial

A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients with Type 2 Diabetes Mellitus and Moderate Renal Impairment who have Inadequate Glycemic Control

Studio randomizzato, in doppio cieco, controllato con placebo, a 3 bracci, a gruppi paralleli, della durata di 52 settimane, multicentrico teso a valutare l’efficacia e la sicurezza di sotagliflozin in pazienti con diabete mellito di tipo 2 e insufficienza renale moderata che presentano un controllo glicemico inadeguato

A.3.1

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

Safety and Efficacy Study of Sotagliflozin on Glucose Control in Patients with Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control

Studio di sicurezza e efficacia di Sotagliflozin sul controllo del glucosio nei pazienti con diabete di tipo 2, compromissione moderata della funzionalità renale e controllo insufficiente dello zucchero nel sangue

A.3.2

Name or abbreviated title of the trial where available

SOTA-CKD3

A.4.1

Sponsor's protocol code number

EFC14837

A.5.3

WHO Universal Trial Reference Number (UTRN)

U1111-1187-8662

A.5.4

Other Identifiers

Name:

Number:

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	SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENT
B.1.3.4	Country	France
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	Sanofi-aventis Recherche & Développement
B.4.2	Country	France
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sanofi SPA
B.5.2	Functional name of contact point	Contact point
B.5.3	Address:
B.5.3.1	Street Address	Via Bodio, 37/B
B.5.3.2	Town/ city	Milano
B.5.3.3	Post code	20158
B.5.3.4	Country	Italy
B.5.4	Telephone number	800226343
B.5.5	Fax number	0239394168
B.5.6	E-mail	informazioni.medicoscientifiche@sanofi.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	No
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	Sotagliflozin
D.3.2	Product code	[SAR439954]
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	SOTAGLIFLOZIN
D.3.9.1	CAS number	1018899-04-1
D.3.9.2	Current sponsor code	SAR439954
D.3.9.4	EV Substance Code	SUB179285
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	200
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	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
Chronic kidney disease stage 3

Diabete mellito di tipo 2 e Insufficienza renale moderata di stadio 3

E.1.1.1

Medical condition in easily understood language

Type 2 diabetes mellitus
Chronic kidney disease stage 3

Diabete mellito di tipo 2 e insufficienza renale moderata di stadio 3

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	23.1
E.1.2	Level	LLT
E.1.2	Classification code	10076410
E.1.2	Term	Chronic kidney disease stage 3
E.1.2	System Organ Class	100000004857

E.1.2 Medical condition or disease under investigation

E.1.2	Version	21.1
E.1.2	Level	PT
E.1.2	Classification code	10067585
E.1.2	Term	Type 2 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

To demonstrate the superiority of sotagliflozin dose 1 and 2 versus placebo on HbA1c reduction in patients with Type 2 diabetes who have inadequate glycemic control and moderate renal impairment

Dimostrare la superiorità di sotagliflozin Dosi 1 e 2 rispetto al placebo nella riduzione dell’emoglobina A1c (HbA1c) in pazienti con diabete di tipo 2 (T2D) che presentano controllo glicemico inadeguato e insufficienza renale moderata.

E.2.2

Secondary objectives of the trial

-To assess the effects of sotagliflozin dose 1 and 2 versus placebo with respect to additional measures of glycemic control, blood pressure, and body weight
-To evaluate the safety of sotagliflozin dose 1 and dose 2 versus placebo

- Valutare gli effetti di sotagliflozin Dosi 1 e 2 rispetto al placebo in base alle misure supplementali del controllo della glicemia, della pressione sanguigna e del peso corporeo.
- Valutare la sicurezza di sotagliflozina dosi 1 e dose 2 contro placebo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Patients with T2D (drug-naïve or on antidiabetic therapy) and documented moderate renal insufficiency defined by an eGFR (based on the 4 variable Modification of Diet in Renal Disease [MDRD] equation) of =30 and <60 mL/min/1.73 m2 (CKD 3A, 3B).
-Patient has given written informed consent to participate in the study in accordance with local regulations.

• Pazienti con T2D (naïve ai farmaci o trattati con terapia antidiabetica) e insufficienza renale moderata documentata, definita tramite un'equazione eGFR (basata su MDRD a 4 variabili) =30 e <60 ml/min/1,73 m2 (CKD 3A, 3B).
• Il paziente ha manifestato il consenso informato scritto per la partecipazione allo studio in conformità alle normative locali

E.4

Principal exclusion criteria

-Hemoglobin A1c (HbA1c) of <7.0% or >11.0%.
-Type 1 diabetes.
-Women of childbearing potential (WOCBP) not willing to use highly effective method(s) of birth control during the study treatment period and the follow-up period, or who are unwilling or unable to be tested for pregnancy during the study.
-Treatment with an SGLT2 inhbitor (canagliflozin, dapagliflozin, empagliflozin) during the last 12 months.
-Uncontrolled high blood pressure.
- Patients with severe anemia, severe cardiovascular (including congestive heart failure New York Heart Association IV), respiratory, hepatic,neurological, psychiatric, or inactive malignant tumor or other major systemic disease or patients with short life expectancy that, according to the Investigator, will preclude their safe participation in this study, or will make implementation of the Protocol or interpretation of the study results difficult.
- Lowe extremity complications (such as skin ulcers, infection, osteomyelitis and gangrene) identified during the Screening period, and still requiring treatment at Randomization

- HbA1c <7,0% o HbA1c >11%
- diabete di tipo 1
- Donne in grado di procreare (WOCBP) che non intendono utilizzare metodi contraccettivi ad elevata efficacia durante il periodo di trattamento e follow-up dello studio, o che non possono o non sono disposte a sottoporsi al test di gravidanza durante lo studio.
- Utilizzo di un inibitore SGLT2 selettivo (ad es. anagliflozin, dapagliflozin o empagliflozin) nei 12 mesi precedenti la Sperimentazione.
- Ipertensione incontrollata
- Pazienti con anemia grave, gravi malattie cardiovascolari (compresa l’insufficienza cardiaca congestizia di classe IV secondo la New York Heart Association ), problemi respiratori, epatici, neurologici, psichiatrici, o tumore maligno attivo o altre condizioni sistematiche importanti, o pazienti che hanno un’aspettativa di vita breve, che in accordo al giudizio dello Speriementare, precluderà la loro partecipazione in sicurezza a questo studio, oppure renda difficile l’attuazione del protocollo o l’interpretazione dei risultati dello studio.
• Complicanze degli arti inferiori (come ulcere della pelle , infezioni, osteomielite e cancrena) identificate durante il periodo di Screening e che richiedono ancora trattamento alla Randomizzazione.

E.5 End points

E.5.1

Primary end point(s)

Change in HbA1c for dose 1 and dose2

Variazione dell’HbA1c per dose 1 e dose 2

E.5.1.1

Timepoint(s) of evaluation of this end point

Baseline to Week 26

dal basale alla settimana 26

E.5.2

Secondary end point(s)

1. Change in Fasting Plasma Glucose (FPG) (Doses 1 and 2)
2. Change in Systolic Blood Pressure (SBP) for patients with SBP =130 mmHg (Doses 1 and 2)
3. Change in Systolic Blood Pressure (SBP) (Doses 1 and 2)
4. Change in body weight (Dose 1 and 2)
5. Percentage change in UACR for patient with UACR > 30 mg/g (doses 1 and 2)
6. Proportion of patient with HbA1c <6.5% (doses 1 and 2)
7. Proportion of patient with HbA1c <7.0% (doses 1 and 2)
8. Proportion of patient with severe adverse events over the study period (doses 1 and 2)

1. Variazione della glicemia a digiuno (FPG) (dose 1 e dose 2) ;
2. Variazione della pressione sistolica (SBP) in pazienti con SBP =130 mmHg; (dose 1 e dose 2)
3. Variazione della pressione sistolica (SBP); (dose 1 e dose 2)
4. Variazione del peso corporeo; (dose 1 e dose 2)
5. Variazione percentuale di UACR per i pazienti con UACR > 30 mg/g (dose 1 e dose 2)
6. Percentuale di pazienti con HbA1c <6,5% (dose 1 e dose 2);
7. Percentuale di pazienti con HbA1c <7.0% (dose 1 e dose 2);
8. Percentuale di pazienti con eventi avversi durante il periodo di studio (dose 1 e dose 2);

E.5.2.1

Timepoint(s) of evaluation of this end point

1. Change in Fasting Plasma Glucose (FPG) : Baseline to Week 26
2. Change in Systolic Blood Pressure (SBP) for patients with SBP =130 mmHg : Baseline to Week 12
3. Change in Systolic Blood Pressure (SBP) : Baseline to Week 12
4. Change in body weight : Baseline to Week 26
5. Change in urinary albumin-to-creatinine ratio (UACR) : Baseline to Week 26
6. Patients with HbA1c <6.5% : Week 26
7. Patients with HbA1c <7.0% : Week 26
8. Patients with adverse events : Week 56

1. Variazione della glicemia a digiuno (FPG) : dal basale alla settimana 26;
2. Variazione della pressione sistolica (SBP) in pazienti con SBP =130 mmHg: dal basale alla settimana 12;
3. Variazione della pressione sistolica (SBP):dal basale alla settimana 12;
4. Variazione del peso corporeo dal basale alla settimana 26;
5. Variazione del rapporto albumina/creatinina nelle urine (UACR): dal basale alla settimana 26 ;
6. pazienti con HbA1c <6,5%, : Settimana 26
7. pazienti con HbA1c <7.0%: Settimana 26
8. pazienti con eventi avversi : Settimana 56

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

Yes

E.6.7

Pharmacodynamic

Yes

E.6.8

Bioequivalence

E.6.9

Dose response

Yes

E.6.10

Pharmacogenetic

Yes

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

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

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

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

Argentina

Brazil

Canada

Colombia

Germany

Hungary

Israel

Italy

Mexico

Poland

Romania

Russian Federation

South Africa

Spain

Ukraine

United States

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

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:

900

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

900

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

654

F.4.2.2

In the whole clinical trial

1800

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)

None

nessuno

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

2017-11-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-09-14

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

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