Clinical Trials Register

Summary
EudraCT Number:	2011-002508-34
Sponsor's Protocol Code Number:	EMR200084-508
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:	2011-10-13
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Spain - AEMPS

A.2

EudraCT number

2011-002508-34

A.3

Full title of the trial

Evaluate adherence to treatment with Glucophage sachets versus tablets in diabetes type 2 patients, previously treated with metformin tablets

Evaluar la adherencia al tratamiento con Dianben sobres en comparación a Dianben comprimidos en pacientes con DM tipo II, previamente tratados con metformina comprimidos

A.3.1

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

Adherencia al tratamiento con Dianben sobres en comparación a Dianben comprimidos

A.4.1

Sponsor's protocol code number

EMR200084-508

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, S.L.
B.1.3.4	Country	Spain
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, S.L.
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	MERCK, S.L.
B.5.2	Functional name of contact point	DEPARTAMENTO MÉDICO
B.5.3	Address:
B.5.3.1	Street Address	MARIA DE MOLINA 40
B.5.3.2	Town/ city	MADRID
B.5.3.3	Post code	28006
B.5.3.4	Country	Spain
B.5.4	Telephone number	34917454400
B.5.5	Fax number	34917454447

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	DIANBEN 850 mg para solución oral
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck SL
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Powder for oral solution
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	METFORMIN HYDROCHLORIDE
D.3.9.1	CAS number	1115-70-4
D.3.9.4	EV Substance Code	SUB03200MIG
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	850
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	DIANBEN 850 mg, comprimidos recubiertos con película
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck SL
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	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	METFORMIN HYDROCHLORIDE
D.3.9.1	CAS number	1115-70-4
D.3.9.4	EV Substance Code	SUB03200MIG
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	850
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

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

Diabetes tipo 2

E.1.1.1

Medical condition in easily understood language

Diabetes

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	14.0
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	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 compare the compliance in both treatment arms

Comparar la adherencia al tratamiento entre ambos brazos de tratamiento

E.2.2

Secondary objectives of the trial

- Patient objetive adherence
- To asses patient satisfaction with the treatment
- To evaluate patients preferences
- Safety of the treatments

- Cumplimiento reportado por el paciente del tratamiento
- Evaluar la satisfacción del paciente con el tratamiento recibido.
- Evaluar las preferencias del paciente en el tratamiento
- Tolerabilidad del tratamiento

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Type 2 Diabetes diagnosed. Baseline Glycaemia > 7,0 mmol/L (126 mg/dL) or overload Glycemia > 11,0 mmol/L (198 mg/dL)
- On treatment with metformin tablets
- To fulfill at any time at least one of the following criteria for cardio-vascular risk:
• BP sistolic > 180 mmHg and/or >110 mmHg diastolic.
or
BP sistolic > 160 mmHg and <70 mmHg diastolic.
or
> 3 CV risk factors
or
Stablished CV disease or nephropathy
- Stablished dose of Metformin > 1.700 mg/day
- Age > 18 years old
- Given informed consent

- Pacientes diagnosticados de Diabetes mellitus tipo 2. Niveles documentados de Glucemia basal ≥ 7,0 mmol/l (126 mg/dl) en mediciones repetidas ó Glucemia después de sobrecarga > 11,0 mmol/l (198 mg/dl),
- En tratamiento con Dianben o Metformina en comprimidos en el momento de su inclusión en el ensayo.
- Pacientes con al menos 2 comorbilidades con tratamiento farmacológico instaurado.
- Dosis de metformina pautada igual o superior a los 1.700 mg/día (2-3 comprimidos/día).
- Pacientes ≥ 18 años.
- Firma del consentimiento informado

E.4

Principal exclusion criteria

- not able to take medication orally
- According to SmPC:
Known hypersensitivity to metformin or any of its excipients
Diabetic ketoacidosis or diabetic precoma in the previous week
Renal impairment or dysfunction (Creatinine clearance < 60 mL/min)
Acute disease which may produce renal dysfunction, tissue hypoxia as dehydration, severe infection, shock, administration of iodinated contrast.
Acute or chronic disease which may produce tissue hypoxia as cardiovascular or respiratory collapse, recent myocardial infarction, shock.
Liver impairment, alcohol poisoning o alcoholism
Lactating
- Participating in other clinical trial in the 30 days prior to randomisation.
- Any other illnes or medical or psiquiatric condition, severe and uncontrolled that could interfere in the patient's participation or in the assesment of the study results.

- Pacientes con algún tipo de impedimento para la toma de fármacos vía oral
- Hipersensibilidad a la metformina o a alguno de los excipientes
- Pacientes que en la semana anterior al reclutamiento hayan referido Cetoacidosis diabética, precoma diabético
- Insuficiencia o disfunción renal (aclaramiento creatinina < 60 mL/min)
- Patología aguda que implique un riesgo de alteración de la función renal como deshidratación, infección grave, shock, administración de contrastes yodados
- Enfermedad aguda o crónica capaz de provocar hipoxia tisular, como insuficiencia cardiaca o respiratoria, infarto de miocardio reciente, shock.
- Insuficiencia hepática, intoxicación alcohólica aguda o alcoholismo
- Lactancia
- Pacientes embarazadas
- Participación en los 30 días previos en otro ensayo clínico con un fármaco en experimentación
- Cualquier problema médico, psicológico, psiquiátrico o social importante y no controlado que pueda interferir en la participación del sujeto en el estudio o la evaluación de los resultados del estudio

E.5 End points

E.5.1

Primary end point(s)

Patient self-reported subjetive compliance. Haynes Sackett test

Cumplimiento con el tratamiento, valorado mediante el test de cumplimiento autocomunicado de Haynes Sackett

E.5.1.1

Timepoint(s) of evaluation of this end point

6 months of treatment after randomization

6 meses de tratamiento desde la aleatorización

E.5.2

Secondary end point(s)

- Objetive compliance to treatment is assesed by the accountability of medication returned. Patient compliant over 80% of adherence.
- Treatment satisfaction and preferences are evaluated with the diabetes Treatment Satisfaction Questionnaire (DTSQ)
- Rate of reported adverse events

- La adherencia objetiva al tratamiento se evaluará mediante el recuento de medicación devuelta por el paciente para establecer el cumplimiento frente a la medicación teórica pautada entre cada visita, expresado en %. Se considera paciente cumplidor aquel con una adherencia > o = 80%
- La satisfacción con el tratamiento así como las preferencias del paciente se evalúa mediante el cuestionario DTSQ en español
- La seguridad y tolerabilidad del tratamiento se evaluarán en función de la tasa de acontecimientos adversos detectados.

E.5.2.1

Timepoint(s) of evaluation of this end point

6 months of treatment after randomization

6 meses de tratamiento desde la aleatorización

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

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

Yes

E.6.13.1

Other scope of the trial description

Adherence to treatment

Adherencia al tratamiento

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)

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

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

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:

140

F.1.3

Elderly (>=65 years)

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

140

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)

No different from the expected normal treatment for this condition

Sin diferencia respecto al tratamiento habitual de la enfermedad en estudio

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

2011-11-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-06

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

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials