E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Diabetes Mellitus, Type 1 |
Diabetes mellitus, de tipo 1 |
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E.1.1.1 | Medical condition in easily understood language |
Diabetes Mellitus, Type 1 |
Diabetes mellitus, de tipo 1 |
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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 | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10045228 |
E.1.2 | Term | Type I 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 effect of 2 dosing algorithms on the efficacy of LY3209590 compared with insulin degludec in study participants with T1DM |
Investigar el efecto de 2 algoritmos de administración sobre la eficacia de LY3209590 en los participantes del estudio con DMT1, en comparación con la insulina degludec. |
|
E.2.2 | Secondary objectives of the trial |
- To investigate the safety of LY3209590 compared with insulin degludec in study participants with T1DM - To characterize the PK of LY3209590 in study participants with T1DM |
- Comparar la seguridad de LY3209590 con la de la insulina degludec en los participantes del estudio con DMT1. - Caracterizar la FC de LY3209590 en los participantes del estudio con DMT1. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Participants must have a diagnosis of type 1 diabetes mellitus for at least 1 year. • Participants must have been using multiple daily injections without interruption for at least 3 months. • Participants must have HbA1c value of ≤9.5%. • Participants must have a body mass index (BMI) of ≤35 kilograms per meter squared (kg/m²). |
• Los participantes deben presentar diagnóstico de diabetes mellitus de tipo 1 desde al menos hace 1 año. • Los participantes deben haber recibido tratamiento con varias inyecciones diarias al menos durante 3 meses sin interrupción. • Los participantes deben presentar una concentración de HbA1c ≤9,5 %. • Los participantes deben presentar un índice de masa corporal (IMC) de ≤35 kilogramos por metro cuadrado (kg/m²). |
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E.4 | Principal exclusion criteria |
• Participants must not have had more than 1 emergency room visit or hospitalization due to poor glucose control within 6 months prior to study screening. • Participants must not have any episodes of severe hypoglycemia and/or hypoglycemia unawareness within the 6 months prior to screening. • Participants must not have any of the following cardiovascular (CV) conditions: acute myocardial infarction, New York Heart Association Class III or IV heart failure, or cerebrovascular accident (stroke). • Participants must not have acute or chronic hepatitis, or obvious clinical signs or symptoms of any other liver disease. • Participants must not have estimated glomerular filtration rate (eGFR) <30 milliliters/minute/1.73 m². • Participants must not have active or untreated cancer. • Participants must not be on chronic (>14 days) systemic glucocorticoid therapy. |
• Los participantes no deben haber acudido a urgencias o haber sido hospitalizados más de una vez por presentar un mal control glucémico en el transcurso de los 6 meses anteriores a la selección del estudio. • Los participantes no deben haber experimentado ningún episodio de hipoglucemia grave y/o de insensibilidad a la hipoglucemia en el transcurso de los 6 meses anteriores a la selección. • Los participantes no deben presentar ninguna de las siguientes enfermedades cardiovasculares (CV): infarto de miocardio agudo, insuficiencia cardíaca de clase III o IV de acuerdo con los criterios de la New York Heart Association (NYHA) o accidente cerebrovascular (ictus). • Los participantes no deben presentar hepatitis aguda o crónica, ni signos o síntomas clínicos manifiestos de cualquier otra hepatopatía. • Los participantes no deben presentar una filtración glomerular estimada (FGe) <30 mililitros/minuto/1,73 m². • Los participantes no deben presentar un cáncer activo o sin tratar. • Los participantes no deben estar recibiendo un tratamiento sistémico con glucocorticoides durante un período prolongado (>14 días). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Change from Baseline in Hemoglobin A1c (HbA1c) |
Variación respecto al período inicial en la concentración de hemoglobina A1c (HbA1c) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
- Change from Baseline in Fasting Glucose - Change from Baseline in Bolus Insulin Dose - Rate of Total Documented Symptomatic Hypoglycemia - Pharmacokinetics (PK): Area Under the Concentration Time Curve (AUC) of LY3209590 |
- Variación respecto al período inicial en la concentración de glucosa en ayunas - Variación respecto al período inicial en la dosis de insulina en bolo - Tasa de episodios totales de hipoglucemia sintomática documentada - Farmacocinética (FC): área bajo la curva de concentración-tiempo (ABC) de LY3209590 |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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 | 3 |
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 | 7 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 20 |
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 |
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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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |