Diabetes Mellitus Clinical Trial
Official title:
A Study of the Effects of Dapagliflozin on Ambulatory Aortic Pressure, Arterial Stiffness and Urine Albumin Excretion in Patients With Type 2 Diabetes
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.
Study design
Screening visit: Potentially eligible patients will be asked to provide written informed
consent. The investigators will record full medical history, clinical examination,
demographic characteristics, electrocardiogram (ECG), body weight, height, body mass index
(BMI) and waist perimeter. Office blood pressure (BP) will be measured by the physicians
three times using a mercury sphygmomanometer [cuffs will be placed at the level of brachial
artery and a three minute interval will intercept each measurement, following 10 minutes of
rest in the seated position (the cuff will cover at least 80% of the brachial circumference
and 2/3 of the brachial length.)]. The investigators will also collect blood samples to
determine glycated hemoglobin (HbA1C), creatinine, glomerular filtration rate (GFR) and liver
function.
Visit 1 (V1): Patients, who fulfill the inclusion and exclusion criteria, will be asked to
visit the sites 1 week after the screening visit (+/-2 days), following a 12-hour fast. Three
measurements of office BP at the level of brachial artery, with a three minutes interval
between each measurement, will be performed with the use of a mercury sphygmomanometer, after
10 minutes-rest in the sitting posture (cuff with bladder size encircling at least 80% of arm
circumference and covering two thirds of arm length). After that, venous blood specimens and
a spot urine specimen will be collected for relevant blood tests and albumin/creatinine ratio
(ACR) respectively. Subsequently, the Mobil-O-Graph monitor with a cuff of appropriate size
will be fitted and the BP recording will be initiated for 24 hours. The device will be
programmed to collect data every 20 minutes, except for 23:00 to 07:00 (data collection every
30 minutes).
Visit 2 (V2): An appointment will be scheduled the following day for the patient to drop-off
the Mobil-O-Graph device. Patients will be randomized in a 1:1 ratio to the dapagliflozin or
placebo group and will start receiving the drug regimen the same day. Moreover, all patients
will receive dietary and lifestyle advice commencing from this visit.
Telephone Visit 1 (ΤV1): A telephone visit (TV1) will be scheduled 6 weeks after V2 (+/-2
days). Patient history will be obtained, emphasizing on possible adverse events during the
previous 6 weeks. Home blood glucose levels, if available, would be also discussed.
Visit 3 (V3): Visit 3 will be scheduled 6 weeks after telephone visit 1 (TV1) (+/-2 days).
The following parameters will be determined: medical history of the last weeks, clinical
examination (including three brachial BP measurements with a mercury sphygmomanometer as
mentioned before), venous blood specimen collection (under 12-hour fast) and the initiation
of 24-hour ambulatory blood pressure monitoring (ABPM) (Mobil-O-Graph device). The patients
will also provide a spot urine specimen for ACR evaluation.
Visit 4 (V4): Visit 4 will be scheduled 1 day after visit 3. Patients will drop-off the
Mobil-O-Graph device.
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