E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with diabetes and high blood pressure |
Pacientes con diabetes y presión arterial elevada |
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E.1.1.1 | Medical condition in easily understood language |
Patients with diabetes and high blood pressure |
Pacientes con diabetes y presión arterial elevada |
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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 | 10012601 |
E.1.2 | Term | 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 investigate the effect of the addition of 10 mg daily of dapagliflozin to the treatment of diabetic patients compared to placebo on the change in nighttime blood pressure (measured by ABPM) over 12 weeks among patients with albuminuria levels levels ≥ 30 and < 3000 mg/g creatinine |
Investigar el efecto de añadir 10mg diarios de dapaglifozina al tratamiento de paciente diabético, en comparación con placebo, sobre los cambios de la presión arterial nocturna (medida mediante monitorización ambulatoria de la presión arterial) a lo largo de 12 semanas en pacientes con niveles de albuminuria entre 30 y 3000 mg/g de creatinina |
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E.2.2 | Secondary objectives of the trial |
1) To investigate the effect of the addition of 10 mg daily of dapagliflozin to the treatment of diabetic patients compared to placebo on the change in nighttime blood pressure (measured by ABPM) over 12 weeks in the subgroup of patients with high (30-300 mg/g creatinine) albuminuria levels. 2) To investigate the effect of the addition of 10 mg daily of dapagliflozin to the treatment of diabetic patients compared to placebo on the change in nighttime blood pressure (measured by ABPM) over 12 weeks in the subgroup of patients with very high (>300 mg/g creatinine) albuminuria levels. 3) Changes in albuminuria, office BP and HBA1C in the two subgroups of patients investigated 4) To describe the potential variability not attributable to treatment of nighttime blood pressure on separate visits among patients with high and very high levels of albuminuria (placebo group). |
1.Investigar el efecto de añadir 10mg diarios de dapaglifozina al tto de paciente diabético, en comparación con placebo, sobre cambios de la presión arterial nocturna (medida con monitorización ambulatoria) a lo largo de 12 semanas en el subgrupo de pacientes con niveles altos de albuminuria (30-300 mg/g creatinina) 2.Investigar el efecto de añadir 10mg diarios de dapaglifozina al tto de paciente diabético, en comparación con placebo, sobre los cambios de la presión arterial nocturna (medida con monitorización ambulatoria de la presión arterial) a lo largo de 12 semanas en el subgrupo de pacientes con niveles muy altos de albuminuria (>300 mg/g creatinina) 3.Investigar cambios en la albuminuria, presión arterial medida en consulta y hemoglobina glicosilada en los 2 grupos de pacientes 4.Describir la variabilidad potencial no atribuible al tto de presión arterial nocturna entre visitas separadas en pacientes con niveles altos/muy altos de albuminuria (grupo placebo). |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with a previous diagnosis of type 2 diabetes and - Estimated glomerular filtration rate (eGFR) > 30mL/min x1,73m2and - Diagnosis of essential hypertension established at least one year before inclusion visit and suboptimal BP control (office BP above 140/70 mmHg) - HbA1C 7.5-10% - Albuminuria levels ≥ 30 mg/g of creatinine |
Pacientes con diagnóstico previo de diabetes tipo 2 y – tasa estimada de filtración glomerular > 30 mL/min x 1,73 m2 y – Diagnóstico de hipertensión arterial esecial con al menos un año de antigüedad y control subóptimo de la presión arterial (presión arterial en consulta por encima de 140/70 mmHg) – Hemoglobina glicosilada entre 7,5 y 10% - Niveles de albuminuria ≥ 30 mg/g de creatinina |
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E.4 | Principal exclusion criteria |
- Age < 18 years old or ≥ 75 years old. - Women of childbearing potential - Type 1 diabetes - Albuminuria above 3000 mg/g of creatinine - Established cardiovascular disease (stable heart failure, peripheral arterial disease or myocardial infarction or stroke within the previous 6 months) - Intolerance to dapagliflozin - On treatment with loop diuretic - Patients who routinely work during nightime (period between 11.00 p.m. and 7.00 a.m.) |
- Edad < 18 años o > 75 años – Mujeres en edad fértil - Diabetes tipo 1 – Albuminuria > 3000 mg/g de creatinina – Enfermedad cardiovascular establecida (insuficiencia cardíaca, enfermedad arterial periférica o infarto agudo de miocardio o accidente vascular cerebral en los últimos meses) – Intolerancia a la dapagliflozina - Estar en tratamiento con diuréticos de asa - Pacientes que trabajan habitualmente en horario nocturno (periodo entre 11.00 p.m. y 7.00 a.m.) |
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E.5 End points |
E.5.1 | Primary end point(s) |
Changes in mean nocturnal BP from baseline (week 0) to last visit (week 12). |
Cambios en la presión arterial nocturna media entre la visita inicial (semana 0) y la final (semana 12) |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Baseline and final visit (week 12) |
Visitas basal y final |
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E.5.2 | Secondary end point(s) |
- Changes in office BP from baseline (week 0) to last visit (week 12). - Changes in HBA1C from baseline (week 0) to last visit (week 12). - Changes in albuminuria from baseline (week 0) to last visit (week 12). - Natural variability of mean nocturnal BP on separate visits (placebo group). |
- Cambios en la presión arterial medida en consulta entre la visita basal (semana o) y la visita final (semana 12) - Cambios en la hemoglobina glicosilada entre la visita basal (semana o) y la visita final (semana 12) - Cambios en la albuminuria entre la visita basal (semana o) y la visita final (semana 12) - Variabilidad natural de la presión arterial nocturna media en visitas separadas (grupo placebo) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Baseline and final visit (week 12) |
Visita basal y final |
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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 | No |
E.6.5 | Efficacy | No |
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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
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 | Yes |
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 | 3 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
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 | |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | |