E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Type II Diabetes Mellitus |
Diabetes Mellitus tipo II |
|
E.1.1.1 | Medical condition in easily understood language |
Type II Diabetes |
Diabetes Mellitus tipo II |
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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 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To compare the two treatment regimens in terms of change of HbA1c from baseline to endpoint (week 24) |
Comparar dos pautas posológicas de tratamiento en relación con el cambio de HbA1c desde la basal hasta la semana 24 |
|
E.2.2 | Secondary objectives of the trial |
To assess the effect of the 2 lixisenatide regimens on: ? The percentage of patients who reached the target of HbA1c < 7% or ? 6.5% at week 24 ? Fasting Plasma Glucose (FPG) ? 7-point Self-Monitored Plasma Glucose (SMPG) profiles ? Body weight To assess the safety and tolerability of the 2 lixisenatide regimens |
Evaluar el efecto de las 2 pautas posológicas de lixisenatida sobre: - porcentaje de pacientes que han alcanzado el nivel objetivo de HbA1c < 7 % o ? 6,5% en la semana 24 Evaluar la seguridad y tolerabilidad de las dos pautas posológicas de lixisenatide - Glucosa plasmática en ayunas (GPA) - Perfiles de autocontrol de la glucosa plasmática (ACGP) de 7 puntos - Peso corporal |
|
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 |
CGM sub-study, 16-Nov-2011, Version1.
CGM exploratory objectives: - Examine the diurnal glucose patterns produced prior to and after the administration of the IMP. - Determine whether postprandial characteristics of glucose homeostasis linked to the underlying physiological defects distinctive of type 2 diabetes were altered. |
Subestudio de la MCG, version 1 de fecha 16/11/2011. Objetivos: ? Examinar los patrones diurnos de la glucosa obtenidos antes y después de la administración del PEI.
? Determinar si se han alterado las características postprandiales de la homeostasis de la glucosa relacionadas con los defectos fisiológicos subyacentes típicos de la diabetes tipo 2. |
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E.3 | Principal inclusion criteria |
? Patients with type 2 diabetes mellitus, diagnosed for at least 1 year before screening visit ? Metformin treatment at a stable dose of at least 1.5 g/day for at least 3 months prior to screening visit. |
- Pacientes con diabetes mellitus tipo 2, diagnosticados al menos 1 año antes de la visita de selección (V1) - Tratamiento con metformina a una dosis estable de al menos 1,5 g/día, durante al menos 3 meses antes de la visita de selección. |
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E.4 | Principal exclusion criteria |
Screening HbA1c < 7.0% and >10.0% - Fasting plasma glucose at screening > 250 mg/dL (> 13.9 mmol/L) - Treatment with glucose-lowering agent(s) other than metformin in a period of 3 months prior to screening, previous use of insulin - Patients who usually do not eat breakfast - Type 1 diabetes mellitus - Body Mass Index (BMI) ? 20 kg/m² and > 40 kg/ m² - Pregnancy or lactation, women of childbearing potential with no effective contraceptive method - Amylase and/or lipase > 3 times the upper limit of the normal laboratory range ( ULN) at screening - ALT> 3ULN at screening - Calcitonin >/= 20 pg/ml (5.9 pmol/L) at screening - History of unexplained pancreatitis, chronic pancreatitis, pancreatectomy. - Personal or immediate family history of medullary thyroid cancer (MTC) or genetic conditions that predisposes to MTC (e.g multiple endocrine neoplasia syndromes) - Any contra-indication related to metformin - Any previous treatment with lixisenatide |
? HbA1c < 7,0 % y > 10,0 % en la selección ? Glucosa plasmática en ayunas > 250 mg/dl (> 13,9 mmol/l) en la selección ? Tratamiento con agentes hipoglucemiantes distintos de metformina en los 3 meses previos a la selección ? Pacientes que no suelen desayunar ? Diabetes mellitus tipo 1 ? Índice de masa corporal (IMC) ? 20 kg/m2 y > 40 kg/m2 ? Mujeres con capacidad reproductora que no utilizan un método anticonceptivo eficaz; embarazo o lactancia. ? Resultados analíticos anómalos en el momento de la selección,incluidos: - Amilasa y/o lipasa > 3 veces el límite superior de la normalidad (LSN) - ALT > 3 veces el LSN - Calcitonina ? 20 pg/ml (5,9 pmol/l) - En mujeres con capacidad reproductora, prueba de embarazo en suero positiva ? Contraindicación a metformina ? Antecedentes de pancreatitis idiopática, pancreatitis crónica, pancreatectomía. ? Antecedentes personales o antecedentes familiares directos de cáncer medular de tiroides (CMT) o enfermedades genéticas que predisponen al CMT (p. ej., síndrome de neoplasias endocrinas múltiples) ? Tratamiento previo con lixisenatida ? Reacción alérgica a cualquier agonista de los receptores de GLP-1 o a metacresol |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change in HbA1c |
Cambio en la HbA1c |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Percentage of patients reaching HbA1c <7 % - Percentage of patients reaching HbA1c ?6.5 % - Change in 7-point self-monitored plasma glucose profile - Change in Fasting plasma glucose - Change in Body weight |
- Porcentaje de pacientes que alcanzan un nivel de HbA1c < 7 % en la semana 24 - Porcentaje de pacientes que alcanzan un nivel de HbA1c ? 6,5 % en la semana 24 - Cambio en la Glucosa plasmática en ayunas (GPA) - Cambio en los perfiles de autocontrol de la glucosa plasmática (ACGP) de 7 puntos - Cambio en el Peso corporal |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Yes |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
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 | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
lixisenatide within 1 hour prior to breakfast |
|
E.8.2.4 | Number of treatment arms in the trial | 2 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 6 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 36 |
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 | No |
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 |
Canada |
Russian Federation |
Ukraine |
United States |
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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 | 1 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |