Clinical Trials Register

Summary
EudraCT Number:	2014-005525-13
Sponsor's Protocol Code Number:	MK-0431-838
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2015-10-05
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

Spain - AEMPS

A.2

EudraCT number

2014-005525-13

A.3

Full title of the trial

A Phase III, Multicenter, Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin Compared with the Addition of Dapagliflozin in Subjects with Type 2 Diabetes Mellitus and Mild Renal Impairment Who Have Inadequate Glycemic Control on Metformin

Ensayo clínico en fase III, multicéntrico, aleatorizado, doble ciego y controlado con un comparador activo para evaluar la seguridad y la eficacia de la adición de sitagliptina en comparación con la adición de dapagliflozina al tratamiento de sujetos con diabetes mellitus de tipo 2 e insuficiencia renal leve que tienen un control insuficiente de la glucemia con metformina

A.3.1

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

Sitagliptin vs. Dapagliflozin As Add-on to Metformin in Subjects with Mild Renal Impairment

Sitagliptina frente a dapagliflozina como complemento de metformina en sujetos con insuficiencia renal leve

A.3.2

Name or abbreviated title of the trial where available

Sitagliptin vs. Dapagliflozin As Add-on to Metformin in Subjects with Mild Renal Impairment

Sitagliptina vs dapagliflozina como complemento de metformina en suj. con insuficiencia renal leve

A.4.1

Sponsor's protocol code number

MK-0431-838

A.5.2

US NCT (ClinicalTrials.gov registry) number

NCT00790205

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	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.1.3.4	Country	United States
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	Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Merck Sharp & Dohme de España S.A.
B.5.2	Functional name of contact point	Investigación Clínica
B.5.3	Address:
B.5.3.1	Street Address	C/ Josefa Valcárcel, 38
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28027
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34913210600
B.5.5	Fax number	+34913210590
B.5.6	E-mail	ensayos_clinicos@merck.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	Yes
D.2.1.1.1	Trade name	JANUVIA
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme Limited
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Januvia
D.3.2	Product code	MK-0431
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	Sitagliptin
D.3.9.1	CAS number	654671-78-0
D.3.9.2	Current sponsor code	MK-0431
D.3.9.3	Other descriptive name	SITAGLIPTIN
D.3.9.4	EV Substance Code	SUB25227
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	100
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	Forxiga (5 mg)
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb/AstraZeneca
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Forxiga (5mg)
D.3.4	Pharmaceutical form	Capsule
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	Dapagliflozin
D.3.9.1	CAS number	461432-26-8
D.3.9.3	Other descriptive name	DAPAGLIFLOZIN
D.3.9.4	EV Substance Code	SUB31650
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	5
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.IMP: 3
D.1.2 and D.1.3	IMP Role	Comparator
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	Forxiga (10 mg)
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb/AstraZeneca
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Forxiga (10 mg)
D.3.4	Pharmaceutical form	Capsule
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	Dapagliflozin
D.3.9.1	CAS number	461432-26-8
D.3.9.3	Other descriptive name	DAPAGLIFLOZIN
D.3.9.4	EV Substance Code	SUB31650
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	10
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Film-coated tablet
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule
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

Diabetes mellitus de tipo 2

E.1.1.1

Medical condition in easily understood language

Type 2 Diabetes Mellitus

Tratamiento de la diabetes mellitus de tipo 2 (DMT2)

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

After 24 weeks, to assess the effect of the addition of sitagliptin compared with the addition of dapagliflozin on A1C and the overall safety and tolerability of sitagliptin in comparison to that of dapagliflozin.

Después de 24 semanas, evaluar el efecto sobre la A1C de la adición de sitagliptina en comparación con la adición de dapagliflozina y evaluar la seguridad y la tolerabilidad globales de sitagliptina en comparación con las de dapagliflozina.

E.2.2

Secondary objectives of the trial

After 24 weeks, to assess the effect of the addition of sitagliptin compared with the addition of dapagliflozin on change from baseline in 2-hr incremental post-prandial glucose excursion and change from baseline in 2-hr post-prandial glucose. To assess, in a subset of subjects, the effect of the addition of sitagliptin compared with that of dapagliflozin on change from baseline in post-prandial insulin AUC, glucagon AUC, and insulin AUC: glucagon AUC ratio. To assess the effect of the addition of sitagliptin compared with that of dapagliflozin on the proportion of subjects at the A1C goal of <7%. To describe the effect of the addition of sitagliptin compared with that of dapagliflozin on change in fasting plasma glucose (FPG) from baseline.

Evaluar el efecto de la adición de sitagliptina en comparación con la adición de dapagliflozina sobre la variación respecto al momento basal de la fluctuación incremental de la glucemia posprandial a las 2 horas y variación respecto al momento basal de la glucemia posprandial (GPP) a las 2 horas.Evaluar, en un subgrupo de sujetos, el efecto de la adición de sitagliptina en comparación con la adición de dapagliflozina sobre la variación respecto al momento basal del AUC de la insulina, el AUC del glucagón y la relación entre la AUC de la insulina y la AUC del glucagón postprandiales.Evaluar el efecto de la adición de sitagliptina en comparación con la adición de dapagliflozina sobre el porcentaje de sujetos que cumplen el objetivo de A1C de <7,0%.Describir el efecto de la adición de sitagliptina en comparación con la adición de dapagliflozina sobre la variación de la glucemia en ayunas (GA) con respecto al momento basal.

E.2.3

Trial contains a sub-study

Yes

E.2.3.1

Full title, date and version of each sub-study and their related objectives

Merck will conduct Future Biomedical Research on DNA (blood) specimens collected during this clinical trial. Such research is for biomarker testing to address emergent questions not described elsewhere in the protocol (as part of the main trial) and will only be conducted on specimens from appropriately consented subjects. The objective of collecting specimens for Future Biomedical Research is to explore and identify biomarkers that inform the scientific understanding of diseases and/or their therapeutic treatments. The overarching goal is to use such information to develop safer, more effective drugs, and/or to ensure that subjects receive the correct dose of the correct drug at the correct time.

Merck llevará a cabo investigaciones biomédicas futuras con las
muestras obtenidas específicamente con estos fines durante este ensayo
clínico.Estas investigaciones tendrán por objeto el análisis de
biomarcadores para abordar aspectos nuevos que no se describen en
otras partes del protocolo (como parte del ensayo principal) y solo se
llevarán a cabo en muestras de los sujetos que hayan otorgado el
consentimiento correspondiente. El objetivo de la obtención de muestras
para investigaciones biomédicas futuras consiste en estudiar e
identificar biomarcadores que proporcionen información a los científicos
sobre las enfermedades y sus tratamientos. El objetivo último es utilizar
tal información para desarrollar vacunas y fármacos más seguros y
eficaces o para garantizar que los pacientes reciban la dosis correcta del
fármaco o la vacuna adecuados en el momento preciso.

E.3

Principal inclusion criteria

In order to be eligible for participation in this trial, the subject must: (1) have T2DM and be > or = to 25 years of age on the day of signing ICF; (2) have an eGFR > or = to 60 mL/min/1.73m2 and <90 mL/min/1.73m2; (3) be on metformin monotherapy > or = to 1500 mg/day for > or = to 8 weeks with a Visit 1/Screening A1C > or = to 7.0% and < or = to 9.0% ( > or = to 53 mmol/mol and < or = to 75 mmol/mol); (4) be > or = to 80% compliant with placebo run-in medication (as determined by site-performed pill count).

Para poder participar en este ensayo, los sujetos deberán: (1) Presentar DMT2 y ser > o = a 25 años de edad el día de la firma del CI. (2) Tener una FGe > o = a 60 ml/min/1,73 m2 y <90 ml/min/1,73 m2. (3) Estar recibiendo tratamiento con metformina en monoterapia > o = a 1500 mg/día durante ?8 semanas con una A1C en la visita 1/selección > o = a 7,0% y < o = a 9,0% (> o = a 53 mmol/mol y < o = a 75 mmol/mol) (4) Tener un cumplimiento > o = a 80% de la medicación de preinclusión con placebo (según lo establecido por el recuento de la medicación realizado por el centro).

E.4

Principal exclusion criteria

The subject must be excluded from participating in the trial if the subject: (1) has a history of T1DM or ketoacidosis; (2) has history of secondary causes of diabetes; (3) has known hypersensitivity or intolerance to any DPP-4 inhibitor or SGLT2 inhibitor; (4) has been treated with prohibited agents (as listed in the protocol) within 12 weeks of Visit 1/Screening; (5) is not weight stable; (6) is at high risk for volume depletion, hypotension and/or electrolyte imbalances, in the opinion of the investigator; (7) is on or likely to require treatment for > or = to 7 consecutive days with non-steroidal anti-inflammatory drugs; (8) is pregnant or breast-feeding; (9) has an exclusionary laboratory value as listed in the protocol; (10) has participated in other studies involving investigational drugs within 30 days prior to Visit 1/Screening or during the pre-randomization period; (11) has FPG consistently >260 mg/dL (14.4. mmol/mol).

Se excluirá de participar en el ensayo a todos los sujetos que cumplan alguno de los criterios siguientes: (1) Presenta antecedentes de diabetes mellitus de tipo 1 o de cetoacidosis. (2) Presenta antecedentes de causas secundarias de diabetes (3) Tiene una hipersensibilidad o intolerancia conocidas a cualquier inhibidor de DPP-4 o inhibidor de SGLT2. (4) Ha recibido tratamiento con alguno de los agentes prohibidos en el protocolo en las 12 semanas previas a la visita 1/selección (5) El sujeto no presenta un peso estable (6) En opinión del investigador, presenta un alto riesgo de hipovolemia, hipotensión y/o desequilibrios electrolíticos. (7) Está recibiendo tratamiento, o es probable que lo necesite, durante > o = a 7 días consecutivos con antiinflamatorios no esteroideos (8) Está embarazada o lactando (9) Tiene valores de laboratorio que excluyen de la participación en el ensayo según protocolo. (10) Ha participado en otros estudios con fármacos en investigación (fase I-IV) en los 30 días anteriores a la visita 1/selección o durante el periodo previo a la aleatorización. (11) Tiene un valor de GA constantemente >260 mg/dl (14,4 mmol/l).

E.5 End points

E.5.1

Primary end point(s)

Change from baseline in A1C

A1C - variación desde el momento basal

E.5.1.1

Timepoint(s) of evaluation of this end point

24 week

semana 24

E.5.2

Secondary end point(s)

(1) Change from baseline in 2-hr incremental post-prandial glucose excursion; (2) change from baseline in 2-hr post-prandial glucose (PPG); (3) change from baseline in post-prandial insulin AUC, glucagon AUC, and insulin AUC:glucagon AUC ratio; (4) proportion of subjects at the A1C goal of <7.0% (<53 mmol/mol); (5) change in fasting plasma glucose (FPG) from baseline.

(1)Variación de la FGPP a las 2 horas desde el momento basal
(2)Variación de la GPP a las 2 horas desde el momento basal y la semana 24
(3)Variación del AUC del glucagón, AUC de la insulina, cociente entre el AUC de la insulina y el cociente AUC del glucagón desde el momento basal
(4)Porcentaje de sujetos con A1C < 7,0% (<53 mmol/mol)
(5)Variación de la GA desde la visita basal y la semana 24

E.5.2.1

Timepoint(s) of evaluation of this end point

24 weeks

semana 24

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

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)

Yes

E.8.2.2

Placebo

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

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

Australia

Brazil

Canada

Colombia

Estonia

Finland

Germany

Hungary

Ireland

Korea, Republic of

Latvia

Lithuania

Mexico

New Zealand

Norway

Peru

Puerto Rico

Romania

Russian Federation

South Africa

Spain

United Kingdom

United States

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:

256

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

300

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

208

F.4.2.2

In the whole clinical trial

556

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)

Subjects who discontinue treatment with blinded study drug but who continue to participate in the trial by providing follow-up information can receive medical and diabetes management by their managing physician or investigator, as appropriate. These subjects may initiate any other therapy as needed (previously prohibited medications will not apply to them). Procurement of other AHAs, including background AHA, is the responsibility of the subject.

Los pacientes que abandonan el tratamiento con el medicamento del estudio ciego pero que continúan participando en el estudio dando información de seguimiento pueden recibir tratamiento médico y de diabetes por su médico o investigador, según corresponda. Estos pacientes pueden iniciar otra terapia según sea necesario (los medicamentos previamente prohibidos no aplicaran a ellos). La adquisición de otros HGs, incluyendo antecedentes de HG, es la responsabilidad del paciente.

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

2015-11-13

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-10-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2017-10-10

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