Clinical Trials Register

Summary
EudraCT Number:	2012-002414-39
Sponsor's Protocol Code Number:	MK-3102-018
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2012-10-29
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

2012-002414-39

A.3

Full title of the trial

A Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess Cardiovascular Outcomes Following Treatment with MK-3102 in Subjects with Type 2 Diabetes Mellitus

Estudio aleatorizado, en doble ciego, controlado con placebo y multicéntrico, para evaluar los resultados cardiovasculares tras el tratamiento con MK-3102 en sujetos con diabetes mellitus de tipo 2

A.3.1

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

A Phase 3 study in Patients with Type 2 Diabetes Mellitus

Estudio Fase 3 en pacientes con Diabetes Mellitus de tipo 2

A.4.1

Sponsor's protocol code number

MK-3102-018

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 Corp., a subsidiary of Merck & Co., Inc.
B.5.2	Functional name of contact point	Global Clinical Trials Operations
B.5.3	Address:
B.5.3.1	Street Address	One Merck Drive
B.5.3.2	Town/ city	Whitehouse Station, NJ
B.5.3.3	Post code	08889-0100
B.5.3.4	Country	United States
B.5.4	Telephone number	+1732 594 2622
B.5.5	Fax number	+1732-594-3560
B.5.6	E-mail	ira_gantz@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	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	MK-3102
D.3.2	Product code	MK-3102
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	Omarigliptin
D.3.9.2	Current sponsor code	MK-3102
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	25
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	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 is a metabolic disorder that is characterized by high blood glucose in the context of insulin resistance and relative insulin deficiency

Diabetes Mellitus de tipo 2 es un desorden metabólico que se caracteriza por alta glucosa en sangre en el contexto de resistencia a insulina y deficiencia de insulina relativa

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	14.1
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 assess the impact of MK-3102 25 mg q.w. on time to confirmed CV outcomes across the MK-3102 program

To assess the safety and tolerability of MK-3102 25 mg q.w.

Evaluar el impacto de MK-3102 25 mg u.v.s. sobre el tiempo hasta los resultados CV confirmados a lo largo del programa.

Evaluar la seguridad y la tolerabilidad de MK-3102 25 mg u.v.s.

E.2.2

Secondary objectives of the trial

To assess the impact of MK-3102 25 mg q.w. on:
a. the key secondary composite confirmed CV endpoint of CV-related death, nonfatal MI, and nonfatal stroke;
b. each of the components of the primary composite endpoint (i.e., confirmed CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring
hospitalization);
c. all-cause mortality

To assess the impact of MK-3102 25 mg q.w. on:
a. change from baseline in A1C over time;
b. in subjects not receiving insulin at baseline, time to initiation of long-term insulin therapy

Evaluar el impacto de MK-3102 25 mg u.v.s. sobre:
a. el criterio compuesto de valoración CV secundario clave confirmado de muerte por causa CV, IM no mortal e ictus no mortal;
b. cada uno de los componentes del criterio compuesto de valoración principal (a saber, muerte por causa CV, IM no mortal, ictus no mortal o angina inestable que requiere hospitalización);
c. la mortalidad por todas las causas.

Evaluar el impacto de MK-3102 25 mg u.v.s. sobre:
a. el cambio en la A1C frente al basal a lo largo del tiempo;
b. en los sujetos que no estuvieran con insulina en el momento basal, tiempo hasta el comienzo de tratamiento insulínico a largo plazo

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Having T2DM and is >/=40 years of age.
2. Receiving one of the following diabetes treatment regimens and has A1C of >/=7.0% and </=10.0%:
(a) treated by diet and exercise alone (not on AHA for >/=12 weeks)
(b) on metformin, a sulfonylurea, a meglitinide, pioglitazone, or an alpha-glucosidase inhibitor as mono- or dual combination therapy continuously for at least 12 weeks (except for pioglitazone for at least 16 weeks) without dose alterations.
(c) on a stable insulin regimen with one of the following insulins, alone or in combination with metformin: intermediate-acting insulin (e.g., NPH); pre-mixed insulin (e.g., Novolog 70/30®, Novolin 70/30®, Humalog 75/25®, or Humulin 70/30®); or long-acting insulin (e.g., glargine, detemir, degludec)
3. Having following preexisting vascular disease:
(a) History of a major clinical manifestation of coronary artery disease (i.e., myocardial infarction, surgical or percutaneous [balloon and/or stent] coronary revascularization procedure, or coronary angiography showing at least one stenosis >/=50% in a major epicardial artery or branch vessel);
(b)Ischemic cerebrovascular disease, including:
- History of ischemic stroke
- History of carotid arterial disease as documented by >/=50% stenosis documented by carotid ultrasound, magnetic resonance imaging (MRI), or angiography, with or without symptoms of neurologic deficit.
(c) Atherosclerotic peripheral arterial disease, as documented by objective - amputation due to vascular disease, current symptoms of intermittent claudication confirmed by an ankle-brachial pressure index or toe brachial pressure index less than 0.9 or history of surgical or percutaneous revascularization procedure.
4. (a) Subject is a female not of reproductive potential defined as one who has either reached natural menopause or had bilateral oophorectomy and/or hysterectomy, or had bilateral tubal ligation at least 6 weeks prior to screening.
(b) Subject is a female of reproductive potential, agrees to remain abstinent from heterosexual activity, or use (or have their partner use) 2 adequate barrier methods of contraception to
prevent pregnancy within the projected duration of the trial and for 21 days after the last dose of study medication.
5. Understanding the trial procedures, alternative treatments available, providing the providing written informed consent, consent for Future Biomedical Research can be provided (not obligatory).

1. Tener DMT2 y >/=40 años de edad.
2. Estar en tratamiento con uno de los siguientes regímenes antidiabéticos y tiene una A1C >/=7,0% y </=10,0%:
(a) tratado solo con dieta y ejercicio (no ha recibido AHG desde hace >/=12 semanas)
(b) con metformina, una sulfonilurea, meglitinida, pioglitazona o un inhibidor de la alfa-glucosidasa en forma de mono o biterapia de forma continua durante como mínimo 12 semanas (excepto como mínimo 16 semanas en el caso de la pioglitazona) sin modificaciones de la dosis.
(c) con un régimen insulínico estable con una de las siguientes insulinas, sola o en combinación con metformina:insulina de acción intermedia (por ejemplo, NPH);premezcla insulínica (por ejemplo, Novolog 70/30®, Novolin 70/30®, Humalog 75/25® o Humulin 70/30®); o insulina de acción prolongada (por ejemplo, glargina, detemir, degludec)
3. El sujeto tiene una enfermedad vascular previa:
(a) Antecedentes de manifestación clínica mayor de arteriopatía coronaria (esto es, infarto de miocardio, procedimiento de revascularización coronaria quirúrgica o percutánea [balón y/o stent] o angiografía coronaria que evidencia como mínimo una estenosis >/=50% en una arteria epicárdica mayor o en una rama);
(b)Enfermedad cerebrovascular isquémica, lo que incluye:
-Antecedentes de ictus isquémico
-Antecedentes de arteriopatía carotídea, documentada como estenosis >/= 50% en ecografía carotídea, resonancia magnética (RM) o angiografía, con o sin síntomas de déficit neurológico.
(c) Arteriopatía aterosclerótica periférica, documentada mediante evidencia objetiva, como amputación por enfermedad vascular, síntomas actuales de claudicación intermitente confirmada mediante un índice de presión tobillo-braquial o un índice de presión braquial en dedo gordo del pie menor de 0,9 o antecedentes de procedimiento de revascularización quirúrgica o percutánea.
4.(a)La sujeto es una mujer sin potencial reproductor que, por definición, es aquella que ha alcanzado la menopausia natural o ha sido sometida a ovariectomía bilateral y/o histerectomía, o a ligadura bilateral de trompas como mínimo 6 semanas antes de la selección.
(b)La sujeto es una mujer con potencial reproductor y está de acuerdo en abstenerse de actividad heterosexual , o utiliza (o hace que su pareja utilice) dos métodos anticonceptivos de barrera adecuados para impedir el embarazo dentro de la duración prevista del ensayo y los 21 días siguientes a la última dosis de la medicación del estudio.
5.Comprensión de los procedimientos del ensayo, de los tratamientos alternativos disponibles y otorgamiento voluntario de consentimiento informado por escrito, consentimiento para la Futura Investigación Biomédica también puede ser otorgado (no obligatorio).

E.4

Principal exclusion criteria

1. History of type 1 diabetes mellitus or a history of ketoacidosis or possibly having type 1 diabetes
2. Beeing treated with rosiglitazone, a DPP-4 inhibitor or a GLP-1 receptor agonist within the prior 12 weeks of Visit 1/Screening.
3. Having a history of hypersensitivity to a DPP-4 inhibitor
4. Participation in trial with investigational compound prior 12 weeks of signing the informed consent or is not willing to refrain from participating in another trial.
5. Beeing in weight loss program, not in the maintenance phase or has started a weight loss medication or has undergone bariatric surgery within 12 months prior to signing the informed consent.
6. Surgical procedure within 4 weeks prior to signing informed consent or has planned major surgery during the trial.
7. Treatment for >/=14 consecutive days or repeated courses of pharmacologic doses of corticosteroids
8. Treatement for hyperthyroidism or thyroid replacement therapy and has not been on a stable dose for at least 6 weeks.
9. Medical history of active liver disease
10. Human immunodeficiency virus (HIV) as assessed by medical history.
11. Worsening signs or symptoms of coronary heart disease or congestive heart failure within the past 3 months.
12. Poorly-controlled hypertension
13. History of malignancy </=5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer, or in situ cervical cancer.
14. Clinically important hematological disorder
15. Exclusionary laboratory values
16. Positive urine pregnancy test.
17. Pregnancy or breast-feeding
18. At the time of signing informed consent using recreational or illicit drugs or has had a recent history of drug abuse.
19. Subject routinely consumes >2 alcoholic drinks per day or >14 alcoholic drinks per
week, or engages in binge drinking.
20. History or current evidence of condition, therapy, lab abnormality or other circumstance that
makes participation not in the subject?s best interest.
21. Donating blood products or has had phlebotomy of >300 mL within 8 weeks of signing informed consent, or intending to donate blood products within the projected duration of the trial OR receiving blood products within 12 weeks of signing informed consent or within the projected duration of the trial.
22. Subject is unlikely to adhere to the trial procedures, keep appointments.

1.Antecedentes de diabetes mellitus de tipo 1 o de cetoacidosis
o tener posiblemente una diabetes de tipo 1
2. Haber sido tratado con rosiglitazona, un inhibidor de DPP-4 o un agonista del receptor de GLP-1 en el plazo de las 12 semanas previas a la Visita 1/Selección.
3. Antecedentes de hipersensibilidad a un inhibidor de DPP-4.
4. Participación en un ensayo en el que ha recibido un fármaco en investigación en el plazo de las 12 semanas previas a la firma del consentimiento informado o no desea abstenerse de participar en otro ensayo.
5.El sujeto participa en un programa de pérdida de peso y no se encuentra en la fase de mantenimiento o ha iniciado un medicamento para perder peso o ha sido sometido a cirugía bariátrica en el plazo de los 12 meses previos a la firma del consentimiento informado.
6. Procedimiento quirúrgico en el plazo de las 4 semanas previas a la firma del consentimiento informado o intervención quirúrgica programada una durante el ensayo.
7. Tratamiento durante >/=14 días consecutivos o ciclos repetidos de corticosteroides a dosis farmacológicas.
8. Tratamiento por hipertiroidismo o tratamiento tiroideo sustitutivo y no haber logrado mantenerse con una dosis estable durante como mínimo 6 semanas.
9. El sujeto tiene antecedentes de enfermedad hepática activa
10.Virus de la inmunodeficiencia humana (VIH), según historia clínica.
11.Signos o síntomas en deterioro de cardiopatía coronaria o de insuficiencia cardiaca congestiva en los 3 últimos meses
12.Hipertensión mal controlada
13.Antecedentes de neoplasia maligna </=5 años antes de la firma del consentimiento informado, excepto en cuanto al carcinoma cutáneo basocelular o espinocelular o al cáncer de cuello uterino in situ adecuadamente tratados.
14.Trastorno hematológico clínicamente importante
15.Valores de laboratorio que no permiten su participación en el estudio
16.Prueba de embarazo en orina positiva
17.La sujeto está embarazada o en lactancia
18.Consumo o utilización de drogas con fines recreativos en el momento de la firma del consentimiento informado, o antecedentes recientes de drogadicción.
19. El sujeto consume habitualmente >2 bebidas alcohólicas al día o >14 bebidas alcohólicas a la semana, o tiene intoxicaciones etílicas agudas.
20.Historia o evidencia actual de cualquier proceso, tratamiento, anomalías de laboratorio u otra circunstancia que hace que su participación no sea lo mejor para él.
21. El sujeto ha donado hemoderivados o ha sido sometido a una flebotomía >300 mL en el plazo de las 8 semanas previas a la firma del consentimiento informado, o pretende donar hemoderivados dentro de la duración prevista del ensayo O ha recibido o está previsto que reciba hemoderivados en el plazo de las 12 semanas siguientes a la firma del consentimiento informado o dentro de la duración planificada del ensayo.
22. Sujeto que no es probable que cumpla con los procedimientos del ensayo, acuda a las citas

E.5 End points

E.5.1

Primary end point(s)

CV endpoints:
a. the key secondary composite confirmed CV endpoint of CV-related death, nonfatal MI, nonfatal stroke;
b. each of the components of the primary composite endpoint (i.e., confirmed CV-related death, nonfatal MI, nonfatal stroke, or unstable angina requiring hospitalization);
c. all-cause mortality.

variables principales CV:
a. el criterio compuesto de valoración CV secundario clave confirmado de muerte por causa CV, IM no mortal e ictus no mortal;
b. cada uno de los componentes del criterio compuesto de valoración principal (a saber, muerte por causa CV, IM no mortal, ictus no mortal o angina inestable que requiere hospitalización);
c. la mortalidad por todas las causas.

E.5.1.1

Timepoint(s) of evaluation of this end point

156 weeks + 21 days

156 semanas + 21 dias

E.5.2

Secondary end point(s)

- change from baseline in A1C over time
- in subjects not receiving insulin at baseline, time to initiation of long-term insulin therapy

-el cambio en la A1C frente al basal a lo largo del tiempo;
-en los sujetos que no estuvieran con insulina en el momento basal, tiempo hasta el comienzo de tratamiento insulínico a largo plazo

E.5.2.1

Timepoint(s) of evaluation of this end point

156 weeks + 21 days

156 semanas + 21 días

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)

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

188

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

Austria

Belgium

Brazil

Bulgaria

Canada

Chile

Colombia

Czech Republic

Denmark

Finland

France

Georgia

Germany

Hong Kong

Hungary

India

Israel

Italy

Japan

Jordan

Korea, Republic of

Lebanon

Malaysia

Mexico

Netherlands

New Zealand

Norway

Peru

Philippines

Poland

Romania

Russian Federation

Saudi Arabia

Serbia

Slovakia

South Africa

Spain

Sweden

Taiwan

Ukraine

United Kingdom

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

Última visita del último paciente

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:

3800

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

200

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

1440

F.4.2.2

In the whole clinical trial

4000

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 will return to their normal standard of care therapy

Los sujetos volverán a su tratamiento de referencia

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

2013-01-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-01-11

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2017-03-22

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