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 |
Diabetes mellitus de tipo 2 |
|
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 | LLT |
E.1.2 | Classification code | 10045242 |
E.1.2 | Term | Type II diabetes mellitus |
E.1.2 | System Organ Class | 100000004861 |
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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 investigate the hypothesis that LY3209590 is noninferior to the comparator (insulin degludec) on glycemic control in study participants with T2D currently on basal insulin |
Investigar la hipótesis de que LY3209590 no es inferior al tratamiento comparativo (insulina degludec) desde el punto de vista del control glucémico en participantes del estudio con DT2 que actualmente reciben una insulina basal |
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E.2.2 | Secondary objectives of the trial |
To demonstrate LY3209590 is superior to insulin degludec in the selected parameters of glycemic control |
Demostrar la superioridad de LY3209590 frente a la insulina degludec en determinados parámetros del control glucémico |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Must be at least 18 years of age at screening (or older per local regulations) Have a diagnosis of type 2 diabetes according to the WHO criteria currently treated with basal insulin (includes biosimilars) with or without non-insulin diabetes therapy which may include up to 3 of the following: - dipeptidyl peptidase (DPP-4) IV inhibitors - SGLT2 inhibitors - metformin - alpha-glucosidase inhibitors, or - GLP-1 receptor agonists Have HbA1c value 6.5%-10% inclusive Have body mass index (BMI) less than or equal to 45kg/m2 |
El paciente debe tener al menos 18 años de edad en el momento de la selección (o una edad superior, si así lo estipula la normativa local) Presentar diagnóstico de diabetes de tipo 2 de acuerdo con los criterios de la OMS y que en la actualidad reciba insulina basal (incluyendo biosimilares), con o sin una terapia antidiabética no insulínica, que puede incluir hasta 3 de los siguientes medicamentos: - inhibidores de la dipeptidilpeptidasa IV (DPP-4) - inhibidores del SGLT2 - metformina - inhibidores de la alfa-glucosidasa; o - agonistas del receptor del GLP-1 Presentar una concentración de HbA1c de entre el 6,5 % y el 10 %, ambos inclusive Presentar un índice de masa corporal (IMC) inferior o igual a 45 kg/m2 |
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E.4 | Principal exclusion criteria |
Have a diagnosis of type 1 diabetes, latent autoimmune diabetes or a specific type of diabetes other than type 2 Have had significant weight gain or loss in the past 3 months Are receiving chronic (>14 days) systemic glucocorticoid therapy Have had New York Heart Association Class IV heart failure or any of the following CV conditions: acute myocardial infarction, cerebrovascular accident (stroke), or coronary bypass surgery have acute or chronic hepatitis, cirrhosis, or obvious clinical signs or symptoms of any other liver disease Have an eGFR <20 mL/min/1.73m2 Have active or untreated malignancy |
Presentar diagnóstico de diabetes de tipo 1, diabetes autoinmunitaria latente o un tipo específico de diabetes distinto de la diabetes de tipo 2 Haber sufrido una pérdida o aumento de peso significativo en los últimos 3 meses Estar recibiendo tratamiento sistémico prolongado (>14 días) con glucocorticoides Haber sufrido insuficiencia cardíaca de clase IV según la New York Heart Association o cualquiera de las siguientes enfermedades CV: infarto agudo de miocardio, accidente cerebrovascular (derrame cerebral), o haberse sometido a una intervención de revascularización coronaria Presentar hepatitis aguda o crónica, cirrosis o signos o síntomas clínicos manifiestos de cualquier otra hepatopatía Presentar una filtración glomerular estimada (FGe) <20 ml/min/1,73m2 Sufrir una neoplasia maligna activa o sin tratar |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from baseline in HbA1c |
Cambio respecto al período inicial en la concentración de HbA1c |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
|
E.5.2 | Secondary end point(s) |
-Change from baseline in HbA1c at Week 26 -The event rate of participant-reported clinically significant nocturnal hypoglycemia (<54 mg/dL or severe) during treatment phase up to Week 78 -Time in glucose range between 70 and 180 mg/dL inclusive measured during the CGM session prior to Week 26 |
- Cambio entre el período inicial y la semana 26 en la concentración de HbA1c - La tasa de acontecimientos notificados por los participantes de hipoglucemia nocturna clínicamente significativa (<54 mg/dl, o un episodio grave) durante la fase de tratamiento, hasta la semana 78 - Tiempo transcurrido en un intervalo de glucosa de entre 70 mg/dl y 180 mg/dl, inclusive, determinado durante la sesión de MCG en una sesión anterior a la semana 26 |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
-Week 26 -Week 78 |
- Semana 26 - Semana 78 |
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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 | 11 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 37 |
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 |
Argentina |
Japan |
Korea, Republic of |
Taiwan |
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
|
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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 | 11 |
E.8.9.1 | In the Member State concerned days | 11 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 2 |
E.8.9.2 | In all countries concerned by the trial days | 2 |