Clinical Trials Register

Summary
EudraCT Number:	2017-001657-13
Sponsor's Protocol Code Number:	GL-LSPT1-3003
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:	2019-07-26
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

2017-001657-13

A.3

Full title of the trial

AN OPEN-LABEL, RANDOMIZED, MULTICENTER, PHASE 3 STUDY TO COMPARE THE IMMUNOGENICITY, EFFICACY, AND SAFETY OF GAN & LEE
INSULIN LISPRO INJECTION TO HUMALOG® (INSULIN LISPRO INJECTION) IN ADULT SUBJECTS WITH TYPE 1 DIABETES MELLITUS

Estudio en fase III abierto, aleatorizado y multicéntrico para comparar la inmunogenicidad, la eficacia y la seguridad de la inyección de insulina lispro de Gan & Lee con Humalog® (inyección de insulina lispro) en sujetos adultos con diabetes mellitus de tipo 1

A.3.1

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

A Clinical Trial to see how your body responds to the Gan & Lee Insulin Lispro Injection and how safe it is as compared to the Humalog® (Insulin Lispro Injection) in Adults with Type 1 Diabetes Mellitus

Un ensayo clínico para ver cómo responde su cuerpo a la inyección de insulina lispro de Gan & Lee y lo seguro que es en comparación con Humalog® (inyección de insulina lispro) en sujetos adultos con diabetes mellitus de tipo 1

A.3.2

Name or abbreviated title of the trial where available

Gan & Lee Evaluation of New Biosimilar for Type 1 Lispro: GENTL(1)

Evaluación de un Biosimilar Nuevo de Tipo 1 Lispro de Gan & Lee: GENTL(1)

A.4.1

Sponsor's protocol code number

GL-LSPT1-3003

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	Gan & Lee Pharmaceuticals USA Corporation
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	Gan & Lee Pharmaceuticals USA Corporation
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	Gan & Lee Pharmaceuticals USA Corporation
B.5.2	Functional name of contact point	Jia Lu, Director, Clinical Sciences
B.5.3	Address:
B.5.3.1	Street Address	520 US Highway 22 East, Suite 302
B.5.3.2	Town/ city	Bridgewater, NJ
B.5.3.3	Post code	08807
B.5.3.4	Country	United States
B.5.4	Telephone number	+18882885395
B.5.6	E-mail	Jia.Lu@ganlee.us

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	Gan & Lee Insulin Lispro Injection
D.3.2	Product code	Gan & Lee Insulin Lispro Injection
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INSULIN LISPRO
D.3.9.1	CAS number	133107-64-9
D.3.9.4	EV Substance Code	SUB08198MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
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	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Humalog®
D.2.1.1.2	Name of the Marketing Authorisation holder	Eli Lilly Nederland B.V.
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	HUMALOG® (INSULIN LISPRO INJECTION)
D.3.2	Product code	HUMALOG®
D.3.4	Pharmaceutical form	Solution for injection in pre-filled pen
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Subcutaneous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	INSULIN LISPRO
D.3.9.1	CAS number	133107-64-9
D.3.9.4	EV Substance Code	SUB08198MIG
D.3.10	Strength
D.3.10.1	Concentration unit	U/ml unit(s)/millilitre
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	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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 1 diabetes mellitus

Diabetes mellitus de tipo 1

E.1.1.1

Medical condition in easily understood language

Type 1 diabetes mellitus

Diabetes mellitus de tipo 1

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	21.1
E.1.2	Level	PT
E.1.2	Classification code	10067584
E.1.2	Term	Type 1 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 immunogenicity of Gan & Lee Insulin Lispro Injection and EU-authorized Humalog following treatment in adult subjects with T1DM

Comparar la inmunogenicidad de la inyección de insulina lispro de Gan & Lee con la de Humalog, autorizado en la UE, después del tratamiento en pacientes adultos con DMT1.

E.2.2

Secondary objectives of the trial

- To evaluate the safety of Gan & Lee Insulin Lispro Injection in comparison with that of EU-authorized Humalog following treatment in adult subjects with T1DM
- To evaluate the efficacy of Gan & Lee Insulin Lispro Injection in comparison with that of EU-authorized Humalog following treatment in adult subjects with T1DM

- Evaluar la seguridad de la inyección de insulina lispro de Gan & Lee en comparación con la de Humalog, autorizado en la UE, después del tratamiento en pacientes adultos con DMT1.
- Evaluar la eficacia de la inyección de insulina lispro de Gan & Lee en comparación con la de Humalog, autorizado en la UE, después del tratamiento en pacientes adultos con DMT1.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or nonpregnant, non-lactating female subjects between the ages of 18 and 75 years, inclusive.
2. Female subjects of child-bearing potential, willing to use contraceptive method(s), agreed by the Investigator, to prevent pregnancy during the study.
3. Ability to provide written, personally signed, and dated informed consent to participate in the study, in accordance with the ICH GCP Guideline E6 and all applicable regulations, before initiating any study-related procedures.
4. Ability to understand and fully comply with all study procedures and restrictions.
5. A confirmed diagnosis of T1DM and who have been on an approved basal-bolus insulin regimen for at least 6 months prior to Screening. The type or brand of insulins should not have changed in the 6 months before Screening.
6. Do not expect to change the brand or type of their basal insulin during the study
7. C-peptide ≤ 1.0 ng/mL
8. HbA1c ≤ 10.0%
9. Body mass index (BMI) ≥ 19 kg/m2 and ≤ 35 kg/m2
10. Adherence to a prudent diet and exercise regimen recommended by the medical provider in accordance with local standard of care or American Diabetes Association recommendations, and willingness to maintain this regimen consistently for the duration of the study

1. Hombres y mujeres que no estén embarazadas ni en período de lactancia de 18 a 75 años de edad, ambos inclusive.
2. Mujeres en edad fértil, dispuestas a usar métodos anticonceptivos, acordados por el investigador, para prevenir el embarazo durante el estudio.
3. Capacidad de proporcionar el consentimiento informado por escrito firmado y fechado para parti-cipar en el estudio, de acuerdo con la directriz E6 de BPC de la ICH y con todos los reglamentos aplicables, antes de iniciar cualquier procedimiento relacionado con el estudio.
4. Capacidad de comprender y cumplir plenamente todos los procedimientos y las restricciones del estudio.
5. Un diagnóstico confirmado de DMT1 y que hayan seguido una pauta aprobada de insulina basal y en bolo durante al menos 6 meses antes de la selección. El tipo o marca de insulina no debe haber cambiado en los 6 meses anteriores a la selección.
6. No espere cambiar la marca o el tipo de su insulina basal durante el estudio Inyección de insulina lispro de Gan & Lee frente a Humalog® en adultos con diabetes tipo 1.
7. Péptido C ≤1,0 ng/ml
8. HbA1c ≤10,0 %
9. Índice de masa corporal (IMC) ≥19 kg/m2 y ≤35 kg/m2
10. Seguir una dieta prudente y una pauta de ejercicio recomendada por el médico de acuerdo con el tratamiento estándar local o las recomendaciones de la Asociación Norteamericana de Diabetes, y voluntad de mantener esta pauta de manera estable durante la duración del estudio.

E.4

Principal exclusion criteria

1. Participation in another clinical study within 30 days or 5 half-lives of last dose of experimental medication before Screening, whichever is longer
2. Previous use of Gan & Lee Insulin Lispro Injection
3. Use of insulin neutral protamine hagedorn or insulin detemir within 6 months prior to study entry
4. Current or expected use of an insulin pump or use of continuous glucose measurement to monitor blood glucose during the study
5. Diabetic ketoacidosis (DKA) within 6 months before Screening
6. Brittle T1DM within 1 year before Screening, defined as more than 2 hospitalizations related to diabetes mellitus (excluding hospitalizations for diagnostic purposes), and/or severe hypoglycemia for which the subject experiences severe cognitive impairment requiring external assistance for recovery
7. Renal replacement therapy required or with an estimated (or measured) glomerular filtration rate < 15 mL/min (Modification of Diet in Renal Disease calculation)
8. Any clinically significant cardiovascular (CV) or cerebrovascular event, e.g., myocardial infarction (MI), acute coronary syndrome (ACS), recent revascularization (including coronary artery bypass graft procedures [CABG], percutaneous coronary intervention [PCI]), transient ischemic attack (TIA), or hemorrhagic or ischemic stroke within 3 months before Screening
9. History of congestive heart failure defined as New York Heart Association (NYHA) Stage III or IV
10. Inadequately controlled or unstable hypertension as defined by a systolic blood pressure (SBP) > 160 mmHg or diastolic blood pressure (DBP) > 100 mmHg at Screening and/or Randomization
11. Inadequately controlled thyroid disease, as reflected by abnormal TSH and free T4 values. (Hypothyroid or hyperthyroid conditions should be resolved or stabilized before Screening according to local standard of care.)
12. Any clinically significant (in the opinion of the Investigator) hematology, chemistry, or urinalysis test results at Screening, including any liver function test > 3X of the upper limit of normal (ULN) or bilirubin > 1.5X of the ULN (subjects with elevated
bilirubin due to Gilbert syndrome are eligible to participate, if such tests were performed in the past)
13. Autonomic neuropathy resulting in a diagnosis of gastroparesis
14. Hemoglobin < 12 g/dL for males or < 11 g/dL for females at Screening
15. Hospitalization within the 14 days before Screening, or planned hospitalization at any time during the study
16. Newly prescribed or high-dose (60 mg/day prednisone or equivalent) treatment with glucocorticosteroids, immunosuppressants, or cytostatic agents due to disorders of the immunological system, such as rheumatoid arthritis, psoriasis, spondyloarthritis, and asthma, within 60 days before Screening (Medications under following scenario are allowed: chronically administered oral, inhaled, topical, or intra-articular corticosteroids at a stable dosage; stable therapy with disease modifying agents [e.g., methotrexate, sulfasalazine]; disease is inactive [e.g., remission, well controlled stable phase]; and no significant changes in treatment scheme are expected.)
17. History of human immunodeficiency virus (HIV) or Hepatitis B or Hepatitis C infections
18. Any unresolved infection or a history of active infection within 30 days before screening other than mild viral illness (as judged by the Investigator)
19. Current use of other medications for diabetes treatment, such as dipeptidyl peptidase 4 inhibitors (DPP4i), glucagon-like peptide 1 receptor agonists (GLP1-R), or sodium glucose cotransporter 2 inhibitors (SGLT2i) (See Appendix 1 [Section 16.1] for a list of prohibited medications)
20. A history of alcohol use of more than two drinks a day on average for the last year, or a history of alcohol or substance abuse within 2 years before Screening
21. Previous (within 3 months before Screening) or anticipated treatment with interferons
22. History of malignancy (except for treated non-melanoma skin cancer and treated cervical adenocarcinoma in situ) within 5 years before Screening
23. Receiving blood transfusion or undergoing plasmapheresis within 6 months before Screening
24. History of splenectomy
25. Intolerance or history of hypersensitivity to insulin lispro or any excipient of the study drugs
26. Any other clinically significant medical or psychiatric condition, or one requiring further evaluation that in the opinion of the Investigator could interfere with conduct of the study or interpretation of the data

1.Participación en otro estudio clínico en los 30 días o 5 semividas previos a la última dosis de medicamento experimental antes de la selección, lo que sea más largo. 2.Uso anterior de la inyección de insulina lispro de GL. 3.Uso de insulina protamina neutra de Hagedorn o insulina detemir en los 6 meses anteriores a la entrada en el estudio. 4.Uso actual o previsto de una bomba de insulina o uso de medición continua de glucosa para controlar la glucemia durante el estudio. 5.Cetoacidosis diabética (CAD) en los 6 meses anteriores a la selección. 6.DMT1 lábil en el plazo de un año antes de la selección, definido como más de 2 hospitaliz relacionadas con la diabetes mellitus (excluyendo hospitaliz con fines diagnósticos), y/o hipoglucemia grave por la cual el sujeto experimenta un deterioro cognitivo grave que requiere asistencia externa para su recuperación. 7.Se requiere tratamiento sustitutivo renal o con índice de filtración glomerular estimada (o medida) <15 ml/min (modifi de la dieta en el cálculo de la enfermedad renal). 8.Cualquier episodio cardiovascular o cerebrovascular clínicamente significativo, por ej, infarto de miocardio , síndrome coronario agudo, revascularización reciente (incluidas cirugía de revascularización coronaria, intervención coronaria percutánea), accidente isquémico transitorio o accidente cerebrovascular hemorrágico o isquémico en los 3 meses anteriores a la selección. 9.Antecedentes de insuficiencia cardíaca congestiva de clase III o IV según lo def por la Asociación de Cardiología de Nueva York. 10.Hipertensión inestable o insuficientemente controlada definida por una presión arterial sistólica >160 mmHg o presión arterial diastólica>100 mmHg en la selección y/o aleatorización.11.Enfermedad de la tiroides insuficientemente controlada, reflejada por valores anómalos de TSH y T4 libre. (Las afecciones hipotiroideas o hipertiroideas deben resolverse o estabilizarse antes de la selección de acuerdo al tratam estándar local). 12.Cualquier resultado de importancia clínica (según el investigador) en las pruebas de hematología, bioquímica o análisis de orina efectuadas en la selección, como valores en las pruebas de la función hepática>3 veces el lím sup de la normalidad o bilirrubina >1,5 veces el LSN (los sujetos con bilirrubina elevada debido al síndrome de Gilbert son aptos para participar, si dichas pruebas se realizaron en el pasado). 13. Neuropatía autónoma que deriva en un diagnós de gastroparesia.14.Hemoglobina<12 g/dl en hombres y <11 g/dl en mujeres en la selección.15.Hospitalización en los 14 d anteriores a la selección, u hospitalización planificada en cualquier momento durante el estudio.16.Tratamiento con glucocorticoesteroides, inmunodepresores o citostáticos recientemente prescritos o en dosis altas (60 mg/día de prednisona o equivalente) debido a trastornos del sistema inmunológico, como artritis reumatoide, psoriasis, espondiloartritis y asma, en los 60 d anteriores a la selección (se permiten los medicamentos en el siguiente contexto: corticoesteroides orales, inhalados, tópicos o intrarticulares administrados crónicamente en una dosis estable; terapia estable con fármacos modificadores de la enfermedad [ej., metotrexato, sulfasalazina]; la enfermedad está inactiva [ej., remisión, fase estable bien controlada]; y no se esperan cambios significativos en el programa de tratamiento).
17.Antecedentes de infecciones por el virus de la inmunodeficiencia humana o de la hepatitis B o C. 18.Cualquier infección no resuelta o antecedentes de infección activa en los 30 d previos a la selección, exceptuando las enfermedades leves o víricas (según el criterio del investigador).19.Uso actual de otros medicamentos para el tratamiento de la diabetes, como inhibidores de la dipeptidil peptidasa 4, los agonistas de los receptores del péptido 1 similares al glucagón o los inhibidores del cotransportador 2 de glucosa y sodio (consulte el Apéndice 1 [Secc 16.1] para obtener una lista de medicamentos prohibidos).20.Antecedentes de consumo de alcohol de más de dos bebidas al día de promedio durante el último año, o antecedentes de alcoholismo o drogadicción en los 2 años anteriores a la selección.21.Tratamiento previo (en los 3 meses antes de la selección) o anticipado con interferones.22.Antecedentes de neoplasia maligna (excepto para cáncer de piel distinto de melanoma tratado y el adenocarcinoma de cuello uterino tratado in situ) en los 5 años anteriores a la selección.23.Haber recibido una transfusión de sangre o haberse sometido a plasmaféresis en los 6 meses anteriores a la selección.24.Antecedentes de esplenectomía.25.Intolerancia o antecedentes de hipersensibilidad a la insulina lispro o a alguno de los excipientes de los fármacos del estudio.26.Cualquier otra dolencia o enfermedad psiquiátrica clínicamente significativa, o alguna que requiera una evaluación adicional que, en opinión del investigador, pueda interferir en la realización del estudio o la interpretación de datos.

E.5 End points

E.5.1

Primary end point(s)

The percentage of subjects in each treatment group who develop treatment-induced AIAs, defined as newly confirmed positive AIA development or important (at least a 4-fold) increase in titers after baseline and up to visit Week 26

El porcentaje de pacientes en cada grupo de tratamiento con AAI inducidos por el tratamiento, definido como el desarrollo de AAI recién confirmado o un aumento importante (de al menos 4 veces) en los títulos después del inicio y hasta la visita de la semana 26.

E.5.1.1

Timepoint(s) of evaluation of this end point

26 weeks

26 semanas

E.5.2

Secondary end point(s)

Immunogenicity
• The percentage of subjects in each treatment group with negative AIA at baseline who develop confirmed positive AIA after baseline and up to visit Week 26
• The percentage of subjects in each treatment group with confirmed positive AIA at baseline and at least a 4-fold increase in titers after baseline and up to visit Week 26
• The mean change from baseline in each treatment group in AIA titers after baseline and up to visit Week 26
• The percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26 who develop any anti-insulin NAbs after baseline and up to visit Week 26
• The percentage of subjects in each treatment group with confirmed positive AIA after baseline and up to visit Week 26
Safety
• The incidence and severity of all treatment-emergent adverse events and the following subgroups:
o Adverse events of special interest
o Serious adverse events, including fatal events
o Adverse events leading to termination of the study treatment and/or early withdrawal from the study
o Treatment-related adverse events
o IP device-related adverse events
o Injection site reactions
• The incidence of clinically significant laboratory abnormalities in physical examination and vital signs
Efficacy
• Change from baseline in HbA1c at visit Week 26 in each treatment group
• The number and percentage of subjects who achieve an HbA1c of ≤ 7.0% at visit Week 26 in each treatment group

Inmunogenicidad
• Porcentaje de pacientes en cada grupo de tratamiento sin AAI al inicio que desarrollan AAI confirmados después del inicio y hasta la visita de la semana 26.
• Porcentaje de pacientes en cada grupo de tratamiento con AAI confirmados al inicio y que presentan un aumento en los títulos de al menos 4 veces después del inicio y hasta la visita de la semana 26.
• Media del cambio con respecto al valor inicial en los títulos de AAI tras el inicio y hasta la semana 26 en cada grupo de tratamiento.
• Porcentaje de pacientes en cada grupo de tratamiento con AAI confirmados después del inicio y hasta la visita de la semana 26 que desarrollan anticuerpos neutralizantes contra la insulina después del inicio y hasta la visita de la semana 26.
• Porcentaje de pacientes en cada grupo de tratamiento con AAI confirmados después del inicio y hasta la visita de la semana 26.
Seguridad
• Incidencia e intensidad de todos los acontecimientos adversos surgidos durante el tratamiento y de los siguientes subgrupos:
o Acontecimientos adversos de especial interés.
o Acontecimientos adversos graves, incluyendo los mortales.
o Acontecimientos adversos que provoquen la terminación del tratamiento del estudio o la retirada prematura del estudio.
o Acontecimientos adversos relacionados con el tratamiento.
o Acontecimientos adversos relacionados con la pluma del MI.
o Reacciones en el lugar de la inyección.
• Incidencia de anomalías de importancia clínica en la exploración física y las constantes vitales.
Eficacia
• Cambio de la HbA1c desde el inicio hasta la visita de la semana 26 en cada grupo de tratamiento.
• Número y porcentaje de pacientes con un valor de HbA1c ≤7,0 % en la visita de la semana 26 en cada grupo de tratamiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

Week 26,
Safety - throughout study

Semana 26,
Seguridad - durante todo el estudio

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

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

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

Czech Republic

Germany

Hungary

Poland

Spain

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

UVUP

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

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:

495

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

220

F.4.2.2

In the whole clinical trial

550

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

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2019-10-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-10-16

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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IMP with orphan designation in the indication
Orphan Designation Number:
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