Effects of Dapagliflozin on Central Hemodynamics and Urine Albumin Excretion in Patients With Type 2 Diabetes.
Status:
Terminated
Trial end date:
2019-10-01
Target enrollment:
Participant gender:
Summary
This study is designed to test the hypothesis that the treatment-induced reductions in the
ambulatory aortic pressure are more pronounced in the group of dapagliflozin than in the
group of placebo.
It is a 12 week, double-blind, randomized, placebo-controlled clinical trial of dapagliflozin
versus placebo in 160 adult patients with type 2 diabetes mellitus (DM). It will be conducted
in three centers.
Potentially eligible patients will be asked to provide written informed consent (Screening
Visit). Patients, who fulfill the inclusion and exclusion criteria, will be asked to visit
the sites one week (Visit 1 - V1) after the screening visit. On Visit 2 (V2) all eligible
patients will be randomized to one of the two treatment arms and will continue with the next
visits as appropriate (Visit 3, Telephone Visit 1, Visit 4-end of study).
Aortic blood pressure (BP) and arterial stiffness parameters will be measured as indicated by
the protocol in V1 and V3 with the Mobil-O-Graph monitor.
Blood samples will be collected as indicated by the protocol in Screening Visit for the
measurement of glycated hemoglobin (HbA1c), creatinine and liver function parameters. In
addition, blood samples will be collected in V1 and V3 for routine hematological and
biochemical tests including creatinine, fasting glucose, HbA1c, lipid profile and liver
function parameters.
Urine samples will be collected as indicated by the protocol in V1 and V3 for the measurement
of albumin to creatinine ratio.