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Study to Asses the Effect of Dapagliflozin on Central Blood Pressure Reduction.

NCT02919059 · Status: UNKNOWN · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2017-03-29

No results posted yet for this study

Summary

This superiority of central pressure versus peripheral measures to predict cardiovascular events has also been reported in general population or in elder people

Conditions

  • Diabetes Mellitus, Type 2

Interventions

DRUG

Dapagliflozin 10 mg

Dagliflozin will be administred once daily before the first meal of the day for the duration of the study or until early discontinuation. Subjects will take the first dose of study drug at the study centre on Day 1. On the day of study visits when fasting blood samples are collected, subjects will be instructed to refrain from taking the study drug before the clinic visit. The subject will be instructed to take the dose of study drug before the subject´s next meal. The study drug must be swallowed whole with liquid and not chewed, divided, dissolved or crushed. If the subject doesn´t take the study drug within 12 hours after the first meal of the day, the dose of the study drug should be skipped for that day and keep on taking the study drug on the following day before the first meal.

DRUG

Glimepiride 4 mg

Glimepiride will be administred once daily before the first meal of the day for the duration of the study or until early discontinuation. Subjects will take the first dose of study drug at the study centre on Day 1. On the day of study visits when fasting blood samples are collected, subjects will be instructed to refrain from taking the study drug before the clinic visit. The subject will be instructed to take the dose of study drug before the subject´s next meal. The study drug must be swallowed whole with liquid and not chewed, divided, dissolved or crushed. If the subject doesn´t take the study drug within 12 hours after the first meal of the day, the dose of the study drug should be skipped for that day and keep on taking the study drug on the following day before the first meal.

Sponsors & Collaborators

  • IInstituto Gallego de Medicina Vascular

    lead OTHER

Principal Investigators

  • Alvaro Hermida, MD, PhD · Hospital Nuestra Señora de la Esperanza

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-13
Primary Completion
2018-12-31
Completion
2019-08-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02919059 on ClinicalTrials.gov