Double Blind Placebo Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics

Sponsor
Aristotle University Of Thessaloniki
Study ID
NCT01001962
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
45 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • empagliflozin — DRUG
    ACTIVE TREATMENT FOR DIABETES
  • Metformin — DRUG
    ACTIVE TREATMENT FOR DIABETES

Study Details

Objectives: Primary 1\. Primary prevention of new onset of hypertension Secondary 1. Reduction of 24h BP in type II diabetics with prehypertension 2. Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects receiving EMPAGLIFLOZIN 3. Reduction in the total cardiovascular risk 4. 3 years morbidity and mortality rates 5. Arterial de-stiffening, reduction in central aortic blood pressure in subjects receiving EMPAGLIFLOZIN

Key Dates

Start date
Jan 31, 2016
Status verified
Apr 2015
Primary completion
Jan 31, 2019
Completion
Jan 31, 2020

Study Design

Enrollment
1,054 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Metformin
    527 Patients treated with Metformin 850x2mg titrated to 1000x2mg Daily oral
  • Active Comparator: Empagliflozin
    527 Patients treated with empagliflozin 10mg titrated to 25 mg Daily oral

Primary Outcome Measure

New onset of hypertension [ Time Frame: 36 months ]

Central Contacts

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