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Summary
EudraCT Number:2014-005375-91
Sponsor's Protocol Code Number:NN9535-4216
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2014-005375-91
A.3Full title of the trial
Efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes
Eficacia y seguridad de semaglutida frente a dulaglutida como complemento de metformina en pacientes con diabetes tipo 2
A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
Efficacy and safety of semaglutide versus dulaglutide as add-on to metformin in subjects with type 2 diabetes
Eficacia y seguridad de semaglutida frente a dulaglutida como complemento de metformina en pacientes con diabetes tipo 2
A.4.1Sponsor's protocol code numberNN9535-4216
A.5.3WHO Universal Trial Reference Number (UTRN)U1111-1164-8495
A.7Trial is part of a Paediatric Investigation Plan No
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorNovo Nordisk A/S
B.1.3.4CountryDenmark
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing supportNovo Nordisk A/S
B.4.2CountryDenmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisationNovo Nordisk A/S
B.5.2Functional name of contact pointGlobal Clinical Registry (GCR,1452)
B.5.3 Address:
B.5.3.1Street AddressNovo Allé
B.5.3.2Town/ cityBagsværd
B.5.3.3Post code2880
B.5.3.4CountryDenmark
B.5.4Telephone number+34913349800
B.5.5Fax number+34913349820
B.5.6E-mailclinicaltrials@novonordisk.com
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation No
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameSemaglutide B 1.34mg/ml PDS290
D.3.4Pharmaceutical form Solution for injection in pre-filled pen
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPSubcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNSemaglutide
D.3.9.1CAS number 910463-68-2
D.3.9.3Other descriptive nameSEMAGLUTIDE
D.3.9.4EV Substance CodeSUB32188
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number1.34
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Yes
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 2
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Trulicity
D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V
D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.4Pharmaceutical form Solution for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPSubcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNdulaglutide
D.3.9.3Other descriptive namedulaglutide
D.3.9.4EV Substance CodeSUB130484
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number1.5
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Yes
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.IMP: 3
D.1.2 and D.1.3IMP RoleComparator
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Trulicity
D.2.1.1.2Name of the Marketing Authorisation holderEli Lilly Nederland B.V
D.2.1.2Country which granted the Marketing AuthorisationEuropean Union
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.4Pharmaceutical form Solution for injection
D.3.4.1Specific paediatric formulation No
D.3.7Routes of administration for this IMPSubcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8INN - Proposed INNdulaglutide
D.3.9.3Other descriptive namedulaglutide
D.3.9.4EV Substance CodeSUB130484
D.3.10 Strength
D.3.10.1Concentration unit mg/ml milligram(s)/millilitre
D.3.10.2Concentration typeequal
D.3.10.3Concentration number3
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin No
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) Yes
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) No
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product No
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Yes
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another 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.1.1Medical condition(s) being investigated
Diabetes Mellitus, Type 2
Diabetes mellitus tipo 2
E.1.1.1Medical condition in easily understood language
Type 2 diabetes
Diabetes tipo 2
E.1.1.2Therapeutic area Diseases [C] - Nutritional and Metabolic Diseases [C18]
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 18.0
E.1.2Level LLT
E.1.2Classification code 10045242
E.1.2Term Type II diabetes mellitus
E.1.2System Organ Class 100000004861
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To compare the effect of once-weekly dosing of two dose levels of subcutaneous semaglutide (0.5 mg and 1.0 mg) versus once-weekly dosing of two dose levels of subcutaneous dulaglutide (0.75 mg and 1.5 mg) on glycaemic control in subjects with type 2 diabetes on a background treatment with metformin.
Comparar el efecto de la administración de semaglutida por vía subcutánea una vez por semana en dos niveles de dosis (0,5 mg y 1,0 mg) frente a la administración de dulaglutida por vía subcutánea una vez por semana en dos niveles de dosis (0,75 mg y 1,5 mg) sobre el control de la glucemia en pacientes con diabetes tipo 2 en tratamiento de base con metformina.
E.2.2Secondary objectives of the trial
To compare the effect of once-weekly dosing of two dose levels of subcutaneous semaglutide (0.5 mg and 1.0 mg) versus once-weekly dosing of two dose levels of subcutaneous dulaglutide (0.75 mg and 1.5 mg) in subjects with type 2 diabetes on a background treatment with metformin with regards to:
- Body weight control
- Blood pressure
- Patient reported outcomes
- Safety and tolerability
Comparar el efecto de la administración de semaglutida por vía subcutánea una vez por semana en dos niveles de dosis (0,5 mg y 1,0 mg) frente a la administración de dulaglutida por vía subcutánea una vez por semana en dos niveles de dosis (0,75 mg y 1,5 mg) sobre el control de la glucemia en pacientes con diabetes tipo 2 en tratamiento de base con metformina, con respecto a lo siguiente:
- Control del peso corporal.
- Presión arterial.
- Resultados comunicados por los pacientes.
- Seguridad y tolerabilidad.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
- Male or female, age higher or equal to 18 years at the time of signing informed consent.
- HbA1c 7.0 ? 10.5% (53 ? 91 mmol/mol) (both inclusive)
- Subjects on stable diabetes treatment with metformin (minimum of 1500 mg/day or maximal tolerated dose documented in the patient medical record) for 90 days prior to screening
- Hombres o mujeres , de edad mayor o igual a 18 años en el momento de la firma del consentimiento informado.
- HbA1c del 7,0% al 10,5% (53 - 91 mmol/mol) (ambos inclusive).
- Tratamiento antidiabético estable con metformina (1500 mg/día como mínimo o la dosis máxima tolerada que conste en la historia clínica del paciente) durante 90 días antes de la selección.
E.4Principal exclusion criteria
- Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
- Any condition, which in the investigator?s opinion might jeopardise subject?s safety or compliance with the protocol
- Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria in a period of 90 days before screening. An exception is short-term insulin treatment for acute illness for a total of less or equal to 14 days
- History of pancreatitis (acute or chronic)
- Screening calcitonin higher or equal to 50 ng/L
- Family or personal history of Multiple Endocrine Neoplasia Type 2 or Medullary Thyroid Carcinoma
- Renal impairment defined as eGFR less than 60 mL/min/1.73 m^2 as per CKD-EPI
- Subjects presently classified as being in New York Heart Association Class IV
- Planned coronary, carotid or peripheral artery revascularisation on the day of screening
- Proliferative retinopathy or maculopathy requiring acute treatment
- History or presence of malignant neoplasms within the last 5 years (except basal and squamous cell skin cancer and in-situ carcinomas)
- Anticipated initiation or change in concomitant medications (for more than 14 consecutive days or on a frequent basis) known to affect weight or glucose metabolism (e.g. orlistat, thyroid hormones, corticosteroids)
- Mujeres embarazadas, en período de lactancia, que pretendan quedarse embarazadas o que estén en edad fértil y no utilicen métodos anticonceptivos adecuados (según exija la normativa o práctica local).
- Cualquier condición que, en opinión del investigador, pueda poner en peligro la seguridad del paciente o el cumplimiento del protocolo.
- Tratamiento con cualquier fármaco indicado para la diabetes o la obesidad distintos de los especificados en los criterios de inclusión durante un período de 90 días antes de la selección. Una excepción es el tratamiento a corto plazo con insulina durante no más de 14 días debido a una enfermedad aguda.
- Antecedentes de pancreatitis (aguda o crónica).
- Calcitonina mayor o igual a 50 ng/l en la selección.
- Antecedentes familiares o personales de neoplasia endocrina múltiple de tipo 2 o de carcinoma medular de tiroides.
- Insuficiencia renal, definida por una FGe menor o igual a 60 ml/min/1,73 m2 según la ecuación del CKD-EPI.
- Pacientes con clase funcional IV según la New York Heart Association (NYHA).
- Revascularización arterial coronaria, carotídea o periférica programada el día de la selección.
- Retinopatía proliferativa o maculopatía que requieran tratamiento urgente.
- Antecedentes o presencia de neoplasia maligna en los últimos cinco años (excepto carcinoma basocelular o espinocelular de la piel y carcinomas in situ).
- Previsión de comienzo o modificación del tratamiento (durante más de 14 días consecutivos) con medicamentos concomitantes que se sabe que afectan al peso o al metabolismo de la glucosa (por ejemplo, orlistat, hormonas tiroideas, corticosteroides).
E.5 End points
E.5.1Primary end point(s)
Change in HbA1c
Variación en la HbA1c
E.5.1.1Timepoint(s) of evaluation of this end point
From baseline to week 40
Desde el momento basal hasta la semana 40
E.5.2Secondary end point(s)
Change in
1. Body weight (kg)
2. Fasting plasma glucose
3. Systolic and diastolic blood pressure
4. Overall scores for patient reported outcomes: Diabetes Treatment Satisfaction Questionnaire

5. Subjects who achieve (yes/no) HbA1c less or equal to 6.5% (48 mmol/mol) American Association of Clinical Endocrinologists target
Variación en:
1. Peso corporal (kg)
2. Glucosa plasmática en ayunas
3. Presión arterial sistólica y diastólica
4. Puntuación total de los resultados comunicados por los pacientes:Cuestionario de satisfacción con el tratamiento de la diabetes (DTSQ).
5. Sujetos que alcancen el objetivo (sí/no) de HbA1c menor o igual a 6,5% (48 mmol/mol) según la American Association of Clinical Endocrinologists (AACE)
E.5.2.1Timepoint(s) of evaluation of this end point
1-4. From baseline to week 40
5. After 40 weeks of treatment
1-4. Desde el momento basal hasta la semana 40
5. Tras 40 semanas de tratamiento
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety Yes
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic No
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others No
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans No
E.7.1.2Bioequivalence study No
E.7.1.3Other No
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) Yes
E.7.4Therapeutic use (Phase IV) No
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open Yes
E.8.1.3Single blind No
E.8.1.4Double blind No
E.8.1.5Parallel group Yes
E.8.1.6Cross over No
E.8.1.7Other No
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
E.8.2.2Placebo No
E.8.2.3Other No
E.8.2.4Number of treatment arms in the trial4
E.8.3 The trial involves single site in the Member State concerned No
E.8.4 The trial involves multiple sites in the Member State concerned Yes
E.8.4.1Number of sites anticipated in Member State concerned7
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA85
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA Yes
E.8.6.2Trial being conducted completely outside of the EEA No
E.8.6.3If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned
Canada
European Union
Hong Kong
India
United States
E.8.7Trial has a data monitoring committee No
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 Último Paciente (UVUP)
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months4
E.8.9.1In the Member State concerned days18
E.8.9.2In all countries concerned by the trial years1
E.8.9.2In all countries concerned by the trial months4
E.8.9.2In all countries concerned by the trial days18
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero No
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
F.1.1.3Newborns (0-27 days) No
F.1.1.4Infants and toddlers (28 days-23 months) No
F.1.1.5Children (2-11years) No
F.1.1.6Adolescents (12-17 years) No
F.1.2Adults (18-64 years) Yes
F.1.2.1Number of subjects for this age range: 957
F.1.3Elderly (>=65 years) Yes
F.1.3.1Number of subjects for this age range: 239
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations Yes
F.3.3.1Women of childbearing potential not using contraception No
F.3.3.2Women of child-bearing potential using contraception Yes
F.3.3.3Pregnant women No
F.3.3.4Nursing women No
F.3.3.5Emergency situation No
F.3.3.6Subjects incapable of giving consent personally No
F.3.3.7Others No
F.4 Planned number of subjects to be included
F.4.1In the member state60
F.4.2 For a multinational trial
F.4.2.1In the EEA 580
F.4.2.2In the whole clinical trial 1196
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
Ninguno
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2015-11-27
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2015-11-19
P. End of Trial
P.End of Trial StatusCompleted

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