NCT01001962

Brief Summary

Objectives: Primary 1\. Primary prevention of new onset of hypertension Secondary

  1. 1.Reduction of 24h BP in type II diabetics with prehypertension
  2. 2.Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects receiving EMPAGLIFLOZIN
  3. 3.Reduction in the total cardiovascular risk
  4. 4.3 years morbidity and mortality rates
  5. 5.Arterial de-stiffening, reduction in central aortic blood pressure in subjects receiving EMPAGLIFLOZIN

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,054

participants targeted

Target at P75+ for phase_4 hypertension

Timeline
Completed

Started Jan 2016

Longer than P75 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 26, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 27, 2009

Completed
6.2 years until next milestone

Study Start

First participant enrolled

January 1, 2016

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
Last Updated

April 7, 2015

Status Verified

April 1, 2015

Enrollment Period

3 years

First QC Date

October 26, 2009

Last Update Submit

April 6, 2015

Conditions

HypertensionType II Diabetes

Keywords

Hypertension in type II diabetesCardiovascular morbidity and mortality

Outcome Measures

Primary Outcomes (1)

  • New onset of hypertension

    36 months

Secondary Outcomes (6)

  • 24h blood pressure levels

    36 months

  • Total cardiovascular risk

    36 months

  • Morbidity cardiovascular

    36 months

  • Arterial stiffness

    36 months

  • Central aortic blood pressure

    36 months

  • +1 more secondary outcomes

Study Arms (2)

Metformin

ACTIVE COMPARATOR

527 Patients treated with Metformin 850x2mg titrated to 1000x2mg Daily oral

Drug: Metformin

Empagliflozin

ACTIVE COMPARATOR

527 Patients treated with empagliflozin 10mg titrated to 25 mg Daily oral

Drug: empagliflozin

Interventions

empagliflozinDRUG

ACTIVE TREATMENT FOR DIABETES

Also known as: JARDIANCE
Empagliflozin
MetforminDRUG

ACTIVE TREATMENT FOR DIABETES

Also known as: GLUCOPHAGE
Metformin

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hypertension 24h ABPM center Papageorgiou Hospital

Thessaloniki, Greece

Location

Related Publications (1)

  • Gnesin F, Thuesen ACB, Kahler LKA, Madsbad S, Hemmingsen B. Metformin monotherapy for adults with type 2 diabetes mellitus. Cochrane Database Syst Rev. 2020 Jun 5;6(6):CD012906. doi: 10.1002/14651858.CD012906.pub2.

    PMID: 32501595DERIVED

MeSH Terms

Conditions

HypertensionDiabetes Mellitus, Type 2

Interventions

empagliflozinMetformin

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Central Study Contacts

VASILEIOS KOTSIS, PROF

CONTACT

+306974748860vkotsis@auth.gr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Med

Study Record Dates

First Submitted

October 26, 2009

First Posted

October 27, 2009

Study Start

January 1, 2016

Primary Completion

January 1, 2019

Study Completion

January 1, 2020

Last Updated

April 7, 2015

Record last verified: 2015-04

Locations

GR(1)