E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with Type 2 Diabetes who have failed to achieve glycemic control with basal insulin and oral antidiabetic agents(OADs) |
Pacientes con diabetes tipo 2 que han fracasado alcanzar el control glucémico con insulina basal y agentes antidiabéticos orales (ADOs). |
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E.1.1.1 | Medical condition in easily understood language |
Patients with Type 2 Diabetes |
Pacientes con diabetes tipo 2 |
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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 | 20.0 |
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 demonstrate that in patients with Type 2 diabetes melitus(T2DM) failing to achieve control on their current basal insulin combined with one or 2 Oral Antidiabetic Drug (OADs), iGlarLixi compared to premixed insulin showed non inferiority of iGlarLixi in terms of Glycated hemoglobin (HbA1c) reduction or superiority on body weight change. |
Demostrar que en pacientes con DMT2 que no han conseguido alcanzar el control con su actual insulina basal combinada con uno o 2 ADO, iGlarLixi en comparación con insulina premezclada 70/30 dos veces al día (2 v/d) mostró la no inferioridad de iGlarLixi en términos de reducción del nivel de HbA1c o la superioridad en el cambio en el peso corporal en la Semana 26. |
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E.2.2 | Secondary objectives of the trial |
-To compare in T2DM patients failing to achieve control on their current basal insulin containing regimen combined to 1 or 2 OADs between treatment arms: -in terms of glycemic control parameters(HbA1c target <7%) and weight -in terms of glycemic control parameters weight and hypoglycemia -in terms of superiority of iGlarLixi on glycemic control parameters -To assess safety and tolerability in each treatment group |
Comparar en pacientes con DMT2 que han fracasado alcanzar el control con su actual pauta de insulina basal combinada con 1 o 2 ADO entre los grupos de tratamiento: -en los términos de los parámetros de control glucémico (objetivo de HbA1c <7%) y peso -en los términos de los parámetros de control glucémico peso e hipoglucemia -en los términos de superioridad de iGlarLixi en los parámetros de control glucémico Para evaluar la seguridad y tolerabilidad en cada grupo de tratamiento |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-Patients with Type 2 dibetes mellitus (T2DM) diagnosed for at least 1 year at the time of screening. -Uncontrolled diabetes as demonstrated by a screening centrally measured glycated hemoglobin (HbA1c) ≥7.5% and ≤10%. -Patients who have been treated with any basal insulin combined to 1 or 2 Oral Antidibetic Drug (OADs) that could be metformin alone or metformin with or without sodium -glucose cotransporter 2 inhibitors (SGLT2i) on stable dose for the last 3 months prior to screening (stable basal insulin therapy defined as maximum change in insulin dose of ±20%). -Signed written informed consent. |
- Pacientes con DMT2 diagnosticada desde hace al menos 1 año en el momento de la selección; - Diabetes no controlada, demostrada por un valor de HbA1c de ≥7,5% y ≤10% medido a nivel central; - Pacientes que han sido tratados con insulina basal en combinación con 1 o 2 ADO que pueden ser metformina en monoterapia o metformina + inhibidor de SGLT-2 en dosis estables durante los últimos 3 meses antes de la selección (el tratamiento estable con insulina basal se define como un cambio máximo en la dosis de insulina de ±20%); - Consentimiento informado por escrito firmado. |
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E.4 | Principal exclusion criteria |
-Age <18 years or age < legal age of majority, whichever is greater, at the time of screening. - Body mass index (BMI) <20 and ≥40 kg/m2. -Fasting plasma glucose (FPG) level >200 mg/dL (11.1 mmol/L) at screening visit via central lab test and confirmed (>200 mg/dL [11.1 mmol/L]) by a repeated test before randomization for patients with basal insulin <30 U at screening. -Type 1 diabetes mellitus or any diabetes other than T2DM. -Basal insulin dose <20 Units (U) and >50 U at screening. -Use of any antidiabetic agent other than basal insulin, metformin or SGLT-2i in the 3 months prior to the screening visit. Note: History of short-term treatment (i.e., ≤10 days) with other insulin types due to intercurrent illness is permitted at the discretion of the Investigator. -Use of weight loss drugs (including over-the-counter and herbal medications) within 12 weeks prior to the screening visit. -Any contraindication to the use of iGlarLixi, premixed insulin, metformin, or SGLT2i for those who used it prior to the study, in accordance with local label. -Pregnant or breast-feeding women, Women of childbearing potential (WOCBP) not protected by highly effective method(s) of birth control and/or who are unwilling or unable to be tested for pregnancy. |
Pacientes <18 años o <mayoría de edad legal, lo que sea mayor, en la visita de selección; Indice de masa corporal IMC <20 y ≥40 kg/m2; Nivel de glucosa plasmática en ayunas (GPA) >200 mg/dl (11,1 mmol/l) en la visita de selección mediante análisis del laboratorio central y confirmada (>200 mg/dl [11,1 mmol/l]) con repetición del análisis antes de la aleatorización en el caso de pacientes con insulina basal <30 U en la selección; Diabetes mellitus tipo 1 o cualquier diabetes que no sea DMT2; Dosis de insulina basal <20 unidades (U) y >50 U en la selección. Uso de cualquier antidiabético que no sea insulina basal, metformina o SGLT-2i en los 3 meses anteriores a la visita de selección. Nota: se permite, a criterio del Investigador, la existencia de antecedentes de tratamiento a corto plazo (es decir, ≤10 días) con otros tipos de insulina debido a una enfermedad intercurrente; Uso de fármacos para la pérdida de peso (incluidos los medicamentos sin receta y los medicamentos a base de plantas) en las 12 semanas anteriores a la visita de selección; Cualquier contraindicación para el uso de insulina premezclada, metformina, o SGLT2i en el caso de aquellos pacientes que los utilizaron antes del estudio, de acuerdo con la ficha técnica local o advertencias/precauciones de uso (cuando sea pertinente) de acuerdo con lo que figure en la Ficha Técnica Nacional del Producto correspondiente; Mujeres embarazadas o en periodo de lactancia; Mujeres en edad fértil (MEF) que no estén protegidas por métodos anticonceptivos de gran eficacia y/o que no acepten o no se les puedan realizar pruebas de embarazo. Las pruebas de embarazo podrán realizarse con más frecuencia en algunos países debido a la legislación local relacionada con las MEF aleatorizadas en los ensayos clínicos; |
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E.5 End points |
E.5.1 | Primary end point(s) |
1. Change in Glycated hemoglobin (HbA1c) 2. Change in weight |
1. Cambio en la hemoglobina glucosilada (HbA1c) 2. Cambio de peso |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Baseline to Week 26 2. Baseline to Week 26 |
1. De basal a semana 26 2. De basal a semana 26 |
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E.5.2 | Secondary end point(s) |
1. Patients with HbA1c target <7% without weight gain: Number of patients with HbA1c target <7% without weight gain at Week 26 2. Patients with HbA1c target <7% without hypoglycemia and without weight gain: Number of patients with HbA1c target <7% without hypoglycemia and without weight gain at Week 26 3. Superiority in HbA1c reduction: Change from baseline in HbA1c to Week 26 4. Hypoglycemia at ≤ 70 mg/dL (3.9 mmol/L): Number of patients with documented hypoglycemia at ≤ 70 mg/dL (3.9 mmol/L) 5. Hypoglycemia at <54 mg/dL (<3.0 mmol/L): Number of patients with documented hypoglycemia at <54 mg/dL (<3.0 mmol/L) 6. Severe hypoglycemia: Number of patients with severe hypoglycemia defined as severe cognitive impairment requiring external assistance for recovery |
1. Pacientes con objetivo de HbA1c <7% sin aumento de peso: Número de pacientes con objetivo de HbA1c <7% sin ganancia de peso en la semana 26 2. Pacientes con objetivo de HbA1c <7% sin hipoglucemia y sin aumento de peso: número de pacientes con objetivo de HbA1c <7% sin hipoglucemia y sin aumento de peso en la semana 26 3. Superioridad en la reducción de HbA1c: cambio desde el inicio en HbA1c a la semana 26 4. Hipoglucemia a ≤ 70 mg / dL (3,9 mmol / L): Número de pacientes con hipoglucemia documentada a ≤ 70 mg / dL (3,9 mmol / L) 5. Hipoglucemia a <54 mg / dL (<3.0 mmol / L): Número de pacientes con hipoglucemia documentada a <54 mg / dL (<3.0 mmol / L) 6. Hipoglucemia grave: Número de pacientes con hipoglucemia grave definida como deterioro cognitivo grave que requiere asistencia externa para la recuperación |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Week 26 2. Week 26 3. Baseline to week 26 4. Baseline to week 26 5. Baseline to week 26 6. Baseline to week 26 |
1. Semana 26 2. Semana 26 3. De basal a semana 26 4. De basal a semana 26 5. De basal a semana 26 6. De basal a semana 26 |
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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 | No |
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) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
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 | 8 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 39 |
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 |
Algeria |
Argentina |
Austria |
Bulgaria |
Czech Republic |
Greece |
India |
Korea, Republic of |
Kuwait |
Macedonia, the former Yugoslav Republic of |
Mexico |
Romania |
Saudi Arabia |
Serbia |
Spain |
Sweden |
Taiwan |
Turkey |
United Arab Emirates |
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E.8.7 | Trial 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
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LVLS |
Última visita del último paciente |
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 3 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 3 |