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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01001962
Recruitment Status : Unknown
Verified April 2015 by Vasilios Kotsis, Aristotle University Of Thessaloniki.
Recruitment status was:  Not yet recruiting
First Posted : October 27, 2009
Last Update Posted : April 7, 2015
Information provided by (Responsible Party):
Vasilios Kotsis, Aristotle University Of Thessaloniki

Brief Summary:



1. Primary prevention of new onset of hypertension


  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

Condition or disease Intervention/treatment Phase
Hypertension Type II Diabetes Drug: empagliflozin Drug: Metformin Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1054 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Double Blind Comparison Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics With Metformin
Study Start Date : January 2016
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2020

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Active Comparator: Metformin
527 Patients treated with Metformin 850x2mg titrated to 1000x2mg Daily oral
Drug: Metformin

Active Comparator: Empagliflozin
527 Patients treated with empagliflozin 10mg titrated to 25 mg Daily oral
Drug: empagliflozin

Primary Outcome Measures :
  1. New onset of hypertension [ Time Frame: 36 months ]

Secondary Outcome Measures :
  1. 24h blood pressure levels [ Time Frame: 36 months ]
  2. Total cardiovascular risk [ Time Frame: 36 months ]
  3. Morbidity cardiovascular [ Time Frame: 36 months ]
  4. Arterial stiffness [ Time Frame: 36 months ]
  5. Central aortic blood pressure [ Time Frame: 36 months ]
  6. Mortality cardiovascular [ Time Frame: 36 months ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   45 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion criteria

  1. Age between 45 and 65 years.
  2. All patients are going to give their informed consent to participate in the study.
  3. Patients who are not receiving antihypertensive or diabetes treatment (newly diagnosed diabetics)
  4. BP between 130 to 140 mmHg for systolic BP (prehypertensives)
  5. Type II diabetes (HbA1c 7.0-8.0)

Exclusion criteria

  1. Known oversensitiveness
  2. chronic renal disease (GFR<60 ml/min) or ESRD
  3. heart or respiratory failure, recent MI, shock
  4. pregnancy or lactation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01001962

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Contact: VASILEIOS KOTSIS, PROF +306974748860

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Hypertension 24h ABPM center Papageorgiou Hospital
Thessaloniki, Greece
Contact: VASILEIOS KOTSIS, PROF         
Principal Investigator: VASILEIOS KOTSIS, PROF         
Sponsors and Collaborators
Aristotle University Of Thessaloniki
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Vasilios Kotsis, Prof. Med, Aristotle University Of Thessaloniki Identifier: NCT01001962    
First Posted: October 27, 2009    Key Record Dates
Last Update Posted: April 7, 2015
Last Verified: April 2015
Keywords provided by Vasilios Kotsis, Aristotle University Of Thessaloniki:
Hypertension in type II diabetes
Cardiovascular morbidity and mortality
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 2
Vascular Diseases
Cardiovascular Diseases
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hypoglycemic Agents
Physiological Effects of Drugs
Sodium-Glucose Transporter 2 Inhibitors
Molecular Mechanisms of Pharmacological Action