E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Patients with type 2 diabetes mellitus (T2DM) receiving standard of care but with inadequate glycemic control and at elevated risk of cardiovascular (CV) events |
En sujetos con DMT2 que reciben un tratamiento convencional, pero tienen un control insuficiente de la glucemia y un riesgo elevado de episodios CV. |
|
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 | 16.1 |
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 |
1. To assess the effect of canagliflozin compared to placebo on progression of albuminuria. |
1. Evaluar el efecto de la canagliflozina, en comparación con placebo, sobre la progresión de la albuminuria. |
|
E.2.2 | Secondary objectives of the trial |
To assess the effect of canagliflozin compared to placebo on: 1. Regression of albuminuria 2. Estimated glomerular filtration rate (eGFR) 3. Urinary albumin/creatinine ratio |
Para evaluar el efecto de la canagliflozina, en comparación con placebo, sobre: 1. La regresión de la albuminuria 2. La variación de la TFGe 3. Cociente albúmina/creatinina en orina |
|
E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Must have a diagnosis of type 2 diabetes mellitus. 2. Must have inadequate diabetes control (as defined by glycosylated hemoglobin level >=7.0% to <=10.5% at screening) 3. History or high risk of CV events. 4. Must be either not on antihyperglycemic agents (AHA) therapy, or on AHA monotherapy, or combination AHA therapy with any approved agent for the control of blood glucose levels. |
1. Varones o mujeres con un diagnóstico de DMT2 2. Con inadecuado control de diabetes (un nivel de HbA1c ? 7,0% y ? 10,5% en la selección) 3. Antecedentes o alto riesgo de acontecimientos CV 4. No reciben ningún AD en la actualidad, o (2) en tratamiento con cualquier AD aprobado en monoterapia o combinado |
|
E.4 | Principal exclusion criteria |
1. History of diabetic ketoacidosis, type 1 diabetes mellitus, pancreas or beta-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy. 2. History of one or more severe hypoglycemic episode within 6 months before screening. 3. History of hereditary glucose-galactose malabsorption or primary renal glucosuria. 4. Ongoing, inadequately controlled thyroid disorder. 5. Renal disease that required treatment with immunosuppressive therapy or a history of chronic dialysis or renal transplant 6. Myocardial infarction, unstable angina, revascularization procedure, or cerebrovascular accident within 3 months before screening. |
1. Antecedentes de cetoacidosis diabética, DMT1, trasplante de páncreas o células beta o diabetes secundaria a pancreatitis o pancreatectomía. 2. Antecedentes de uno o más episodios de hipoglucemia grave en los 6 meses anteriores a la selección. 3. Antecedentes de malabsorción hereditaria de glucosa-galactosa o glucosuria renal primaria. 4. Trastornos tiroideos mal controlados en la actualidad. 5. Nefropatía que precise tratamiento con inmunodepresores o antecedentes de diálisis crónica o trasplante renal. 6. Infarto de miocardio, angina inestable, procedimiento de revascularización o accidente cerebrovascular en los 3 meses previos la selección. |
|
E.5 End points |
E.5.1 | Primary end point(s) |
1. Number of participants with progression of albuminuria |
1. Número de sujetos con progresión de albuminuria |
|
E.5.1.1 | Timepoint(s) of evaluation of this end point |
1. Baseline, Week 26, 52, 78, 104, 156 |
1. Visita basal, semana 26, 52, 78, 104, 156 |
|
E.5.2 | Secondary end point(s) |
1. Number of participants with regression of albuminuria 2. Change in estimated glomerular filtration rate (eGFR) from baseline to the last off-treatment measurement. 3. Urinary albumin/creatinine ratio at last on-treatment visit |
1. La regresión de la albuminuria 2. La variación de la TFGe entre el momento basal y el último valor observado en el período sin tratamiento. 3. Cociente albúmina/creatinina en orina |
|
E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Baseline, Week 26, 52, 78, 104, 156 2. Baseline, up to Day 30 of post treatment follow-up 3. Baseline, Week 156 |
1. Visita basal, semana 26, 52, 78, 104, 156 2. Visita basal, hasta día 30 de seguimiento post tratamiento 3. vista basal, seman 156 |
|
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) | 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 | 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 | 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 | 34 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 190 |
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 |
Belgium |
Canada |
China |
France |
Italy |
Netherlands |
New Zealand |
Sweden |
Argentina |
Australia |
Brazil |
Czech Republic |
Germany |
Hungary |
Korea, Republic of |
Malaysia |
Spain |
Mexico |
Poland |
Russian Federation |
Taiwan |
Ukraine |
United Kingdom |
United States |
|
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
|
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 | 3 |
E.8.9.1 | In the Member State concerned months | 6 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 6 |