Patients with diabetes and high blood pressure MedDRA version: 20.0 Level: PT Classification code 10012601 Term: Diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: Forxiga 10 mg
Product Name: Forxiga 10 mg
Pharmaceutical Form: Film-coated tablet
Pharmaceutical form of the placebo: Film-coated tablet
Route of administration of the placebo: Oral use
Sponsors
LM Diagnósticos S.L.
Eligibility
Sex/Gender
All
Inclusion criteria
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 Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 140 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 85
Exclusion criteria
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.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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 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).;Primary end point(s): Changes in mean nocturnal BP from baseline (week 0) to last visit (week 12).;Timepoint(s) of evaluation of this end point: Baseline and final visit (week 12) | — |
Secondary
| Measure | Time frame |
|---|---|
| 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).;Timepoint(s) of evaluation of this end point: Baseline and final visit (week 12) | — |
Countries
Spain
Contacts
Public ContactODDS-Proyectos
ODDS, S.L.
Outcome results
None listed