| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| type 2 diabetes mellitus |
| diabetes mellitus tipo 2 |
|
| E.1.1.1 | Medical condition in easily understood language |
| type 2 diabetes mellitus |
| diabetes mellitus 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 |
|
| 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 |
The main objective of the trial is to demonstrate a dose-relationship of BI 456906 on HbA1c
(absolute change) from baseline to Week 16 relative to placebo in patients with T2DM. |
| El objetivo principal del ensayo es demostrar una relación entre la de dosis de BI 456906 y la HbA1c (cambio absoluto) desde el inicio hasta la semana 16, en comparación con el placebo, en pacientes con DMT2. |
|
| E.2.2 | Secondary objectives of the trial |
Secondary objectives are to assess the effect of BI 456906 on change in body weight. An
open-label comparator (semaglutide) will allow for comparison of the effects against a pure
GLP-1R agonist. |
| Los objetivos secundarios son evaluar el efecto de BI 456906 sobre el cambio en el peso corporal. Un comparador de etiqueta abierta (semaglutida) permitirá la comparación de los efectos frente a un agonista puro de GLP-1R. |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Signed and dated written informed consent in accordance with ICH GCP and local legislation prior to admission to the trial.
2. Male and female patients 18 years to 75 years (both inclusive) of age on the day of signing informed consent.
3. Diagnosis of T2DM at least 6 months prior to informed consent.
4. HbA1c 7.0%-10.0% (both inclusive).
5. Treatment with a stable dose of metformin ≥ 1000mg/day for at least 3 months prior to screening.
6. Body Mass Index (BMI) 25kg/m2-50 kg/m2 (both inclusive) at screening.
7. Women of childbearing potential and men able to father a child must be ready and able to use highly effective methods of birth control. |
1. Consentimiento informado por escrito, firmado y fechado de conformidad con las normas de BPC de la ICH-GCP y la legislación local antes de la admisión al ensayo.
2. Pacientes de ambos sexos entre 18 y 75 años de edad (ambos inclusive) el día de la firma del consentimiento informado.
3. Diagnóstico de DMT2 al menos 6 meses antes del consentimiento informado.
4. HbA1c 7.0%-10.0% (ambos inclusive)
5. Tratamiento con una dosis estable de metformina ≥1.000mg/día durante al menos 3 meses antes de la selección.
6. Índice de Masa Corporal (IMC) 25 kg/m2 - 50 kg/m2 (ambos inclusive) en la selección.
7. Las mujeres con posibilidad de quedarse embarazadas y los hombres que puedan engendrar un hijo/a deben estar dispuestos a usar métodos anticonceptivos de elevada eficacia. |
|
| E.4 | Principal exclusion criteria |
1. Patients with type 1 diabetes.
2. Exposure to semaglutide, or other GLP-1R agonists (including combination products) within 3 months prior to screening, or any previous exposure to BI 456906.
3. Any additional oral anti-hypergylcemic medication beyond metformin within the 3 months prior to screening.
4. Use of insulin for glycemic control within 12 months prior to screening.
5. Resting Heart Rate >100 beats per minute (bpm) or supine blood pressure ≥160/95 mmHg at screening.
6. A marked baseline prolongation of QT/QTc interval or any other clinically significant ECG finding at screening.
7. Body weight change of +/- 5% in the past 3 months or on anti-obesity therapies at any time during the 6 months prior to randomization.
8. Treatment for any clinical condition that requires continuous oral pharmacotheraphy during the trial except for metformin, anti-hypertensives, thyroid hormone replacement, lipid lowering, proton pump inhibitors, H2 blockers for GERD, analgesics, and inhaled respiratory medications, with a stable dose for at least 3 monts prior to screening.
9. Any suicidal behavior in the past 2 years, any suicidal ideation of type 4 or 5 in the C-SSRS in the past 3 months at screening.
10. Chronic or relevant acute infections.
11. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
Further criteria apply. |
1. Pacientes con diabetes tipo 1.
2. Exposición a semaglutida u otros agonistas de GLP-1R (incluidos los productos combinados) en los 3 meses anteriores a la selección o cualquier exposición previa a BI 456906.
3. Cualquier medicamento antihiperglucemiante oral adicional más allá de la metformina en los 3 meses anteriores a la selección.
4. Uso de insulina para el control glucémico en los 12 meses previos a la selección.
5. Frecuencia cardíaca en reposo >100 latidos por minuto (lpm) o presión arterial en decúbito supino ≥160/95 mmHg en la selección.
6. Una prolongación importante del intervalo QT / QTc inicial o cualquier otro hallazgo electrocardiográfico clínicamente significativo en la selección.
7. Cambio en el peso corporal de +/- 5 % en los últimos 3 meses o con tratamientos antiobesidad en cualquier momento durante los 6 meses anteriores a la aleatorización.
8. Tratamiento de cualquier afección clínica que requiera tratamiento farmacológico oral continuo durante el ensayo excepto metformina, antihipertensivos, tratamiento sustitutivo con hormonas tiroideas, tratamiento hipolipemiante, inhibidores de la bomba de protones, antagonistas H2 de la ERGE, analgésicos y medicamentos respiratorios inhalados, con una dosis estable durante al menos 3 meses antes de la selección.
9. Cualquier conducta suicida en los últimos 2 años, cualquier ideación suicida de tipo 4 o 5 en la C-SSRS en los últimos 3 meses anteriores a la selección.
10. Infecciones agudas crónicas o relevantes.
11. Mujeres embarazadas, en periodo de lactancia o que prevean quedarse embarazadas durante el periodo del estudio.
Se aplican criterios adicionales. |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
| 1) Absolute change in HbA1c from baseline to 16 weeks |
| 1) Cambio absoluto en la HbA1c desde el inicio hasta las 16 semanas |
|
| E.5.1.1 | Timepoint(s) of evaluation of this end point |
| 1) 16 weeks |
| 1) 16 semanas |
|
| E.5.2 | Secondary end point(s) |
1) The relative body weight change from baseline to 16 weeks (key secondary endpoint).
2) The absolute body weight change from baseline to 16 weeks.
3) The absolute change in waist circumference from baseline to 16 weeks.
4) The percentage of patients with 5% or greater body weight loss from baseline to 16 weeks.
5) The percentage of patients with 10% or greater body weight loss from baseline to 16 weeks. |
1) Cambio relativo en el peso corporal desde el inicio hasta las 16 semanas (criterio secundario de valoración clave).
2) Cambio absoluto en el peso corporal desde el inicio hasta las 16 semanas.
3) Cambio absoluto en el perímetro de la cintura desde el inicio hasta las 16 semanas.
4) Porcentaje de pacientes con una pérdida de peso corporal del 5% o mayor desde el inicio hasta las 16 semanas.
5) Porcentaje de pacientes con una pérdida de peso corporal del 10% o mayor desde el inicio hasta las 16 semanas. |
|
| E.5.2.1 | Timepoint(s) of evaluation of this end point |
1) 16 weeks
2) 16 weeks
3) 16 weeks
4) 16 weeks
5) 16 weeks |
1) 16 semanas
2) 16 semanas
3) 16 semanas
4) 16 semanas
5) 16 semanas |
|
| 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 | Yes |
| E.6.7 | Pharmacodynamic | Yes |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | Yes |
| E.6.10 | Pharmacogenetic | Yes |
| E.6.11 | Pharmacogenomic | Yes |
| 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 | No |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | Yes |
| 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 | Yes |
| E.8.2.3 | Other | Yes |
| E.8.2.3.1 | Comparator description |
|
| E.8.2.4 | Number of treatment arms in the trial | 7 |
| 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 | 3 |
| E.8.5 | The trial involves multiple Member States | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 25 |
| 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 |
| Australia |
| Austria |
| Canada |
| Czech Republic |
| Germany |
| Hungary |
| Italy |
| Korea, Republic of |
| New Zealand |
| Poland |
| Spain |
| Taiwan |
| United Kingdom |
| United States |
|
| 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
|
| 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 | 4 |
| E.8.9.1 | In the Member State concerned days | 20 |
| 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 | 4 |
| E.8.9.2 | In all countries concerned by the trial days | 20 |
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