Effect of Dapagliflozin on Nighttime Blood Pressure in Type 2 Diabetes
Status:
Unknown status
Trial end date:
2020-02-01
Target enrollment:
Participant gender:
Summary
Centres: Three university hospitals and the primary care centres in their area in Madrid
(Clínico San Carlos, La Paz, 12 de Octubre) Type of study: Randomized, multicentric,
placebo-controlled, single-blind pilot study Main outcome: Nighttime blood pressure in type 2
diabetic patients Objective: To investigate the effect of the addition of 10 mg daily of
dapagliflozin to the treatment of diabetic patients compared to the addition of placebo on
the change in nighttime blood pressure (measured by ABPM) over 12 weeks among patients
withalbuminuria levels ≥ 30 and < 3000 mg/g creatinine and estimated glomerular filtration
rate ≥ 60 mL/min/1.73 m2..
Patients: 225 patients with a previous diagnosis of type 2 diabetes and eGFR> 30mL/min
x1,73m2, office BP above 140/70 mmHg, HbA1C 7.5-10%, albuminuria levels between 30 mg/g
creatinine and 3000 mg/g creatinine and estimated glomerular filtration rate ≥ 60 mL/min/1.73
m2.
Intervention: 10 mg once daily of dapagliflozin or placebo resembling dapagliflozin.