HypertensionPhase 4PREHYPDNCT01001962
Double Blind Placebo Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics
A Phase 4 study testing empagliflozin and Metformin in people with Hypertension and Type II Diabetes, run by Aristotle University Of Thessaloniki at 1 site in Greece.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 45 to 65 years
- Conditions the study is for
- Hypertension, Type II Diabetes
- What is being tested?
- empagliflozin and Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,054 participants
- Where
- 1 siteGreece
- Study dates
- Jan 2016to Jan 2020
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Known oversensitiveness
- chronic renal disease (GFR<60 ml/min) or ESRD
- heart or respiratory failure, recent MI, shock
- pregnancy or lactation.
Trial locations and contacts
1 site in 1 country.
Greece1 site
Hypertension 24h ABPM center Papageorgiou Hospital
Thessaloniki
VASILEIOS KOTSIS, PROF
VASILEIOS KOTSIS, PROF
About this study
Official title: Double Blind Comparison Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics With Metformin
Objectives:
Primary
- Primary prevention of new onset of hypertension
Secondary
- Reduction of 24h BP in type II diabetics with prehypertension
- Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects receiving EMPAGLIFLOZIN
- Reduction in the total cardiovascular risk
- 3 years morbidity and mortality rates
- Arterial de-stiffening, reduction in central aortic blood pressure in subjects receiving EMPAGLIFLOZIN
Read the detailed description
Study rationale: The majority of patients with diabetes are having higher blood pressure than optimal. More than 30% of patients with type II diabetes are prehypertensives with systolic blood pressure between 130 and 140 mmHg. If a drug for diabetes has an impact on blood pressure in such patients then this drug will reduce cardiovascular risk beyond the reduction on glucose levels. There are some evidence that EMPAGLIFLOZIN is reducing blood pressure levels but a comprehensive study is not available.
Timelines and Study duration:
Start date : 01-01-2016 End date : 01-01-2019 Clinical Study Report date: June 2018 Publication date: 2018, 2018, 2019,2020
Methodology:
Inclusion criteria
- Age between 45 and 60 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)
Exclusion criteria Known oversensitiveness, chronic renal disease (GFR<60 ml/min) or ESRD, heart or respiratory failure, recent MI, shock and pregnancy or lactation.
Study drugs:
Clinical examination 0,1,6,12,24,36 months.
- Duration and follow-up: 3 years
- Collected data: Ambulatory blood pressure monitoring, 24h SBP and DBP in time 0,12, 24 months.
- BMI, waist/hip ratio in time 0, 12, 24,36 months.
- HbA1c, insulin in time 0, 1, 6,12, 24,36 months.
- K, Na, Cr, BUN, Chol, Tg, HDL, LDL,ALT, AST in time 0, 1, 6,12, 24,36 months.
Number of patients: 1054
Sample size justification:
The reduction in mean 24h SBP expected to be 2.5 mmHg. Previous studies from our group reported an 12-14mmHg SD for 24h mean SBP. The sample size required at the two sided 5% significance level and 90% power is 527 patients per drug arm.
Statistics/Data Analysis Stata Estimated sample size for two-sample comparison of means Test Ho: m1 = m2, where m1 is the mean in population 1 and m2 is the mean in population 2
Assumptions:
alpha = 0.0500 (two-sided) power = 0.9000 m1 = 130 m2 = 132.5 sd1 = 12 sd2 = 13 n2/n1 = 1.00
Estimated required sample sizes:
n1 = 527 n2 = 527
Population: Diabetes, prehypertension, outpatients. I
- Conditions
- Hypertension, Type II Diabetes
- Being tested
- empagliflozin, Metformin
- Keywords
- Hypertension in type II diabetes, Cardiovascular morbidity and mortality
- Medical subject headings
- Hypertension, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
empagliflozinDrug
Also called JARDIANCE
ACTIVE TREATMENT FOR DIABETES
MetforminDrug
Also called GLUCOPHAGE
ACTIVE TREATMENT FOR DIABETES
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | 527 Patients treated with Metformin 850x2mg titrated to 1000x2mg Daily oral Receives: Drug: Metformin |
| Empagliflozin | Active comparator | 527 Patients treated with empagliflozin 10mg titrated to 25 mg Daily oral Receives: Drug: empagliflozin |
What is being measured
The primary outcome is the main question the study is designed to answer.
New onset of hypertension
Measured: 36 months
Secondary outcomes (6)
24h blood pressure levels
Measured: 36 months
Total cardiovascular risk
Measured: 36 months
Morbidity cardiovascular
Measured: 36 months
Arterial stiffness
Measured: 36 months
Central aortic blood pressure
Measured: 36 months
Mortality cardiovascular
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2009 (estimated)
- Study startJan 2016
- Primary completionJan 2019 (estimated)
- Study completionJan 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- More trials run by Aristotle University Of ThessalonikiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 1,054 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aristotle University Of Thessaloniki
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasilios Kotsis, Aristotle University Of Thessaloniki
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01001962
- Sponsor's protocol ID
- PREHYPERTENSION
- Acronym
- PREHYPD
- Status last verified
- Apr 2015
- First submitted
- 26 Oct 2009
- Last updated
- 7 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32501595
Study at a glance
From the registry record, last updated by the sponsor on 7 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double Blind Comparison Study of JARDIANCE® (Empagliflozin) in Prehypertensives Type II Diabetics With Metformin
- ClinicalTrials.gov ID
- NCT01001962
- Acronym / sponsor ID
- PREHYPD / PREHYPERTENSION
- Conditions
- Hypertension, Type II Diabetes
- Keywords
- Hypertension in type II diabetes, Cardiovascular morbidity and mortality
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,054 participants (estimated)
- Lead sponsor
- Aristotle University Of ThessalonikiUniversity, hospital or other
- Study start
- Jan 2016
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2020 (estimated)
- First posted
- 27 Oct 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
Primary
- Primary prevention of new onset of hypertension
Secondary
- Reduction of 24h BP in type II diabetics with prehypertension
- Reduction of non dipping status, day and nighttime BP, morning BP surge in subjects receiving EMPAGLIFLOZIN
- Reduction in the total cardiovascular risk
- 3 years morbidity and mortality rates
- Arterial de-stiffening, reduction in central aortic blood pressure in subjects receiving EMPAGLIFLOZIN
Detailed description
Study rationale: The majority of patients with diabetes are having higher blood pressure than optimal. More than 30% of patients with type II diabetes are prehypertensives with systolic blood pressure between 130 and 140 mmHg. If a drug for diabetes has an impact on blood pressure in such patients then this drug will reduce cardiovascular risk beyond the reduction on glucose levels. There are some evidence that EMPAGLIFLOZIN is reducing blood pressure levels but a comprehensive study is not available.
Timelines and Study duration:
Start date : 01-01-2016 End date : 01-01-2019 Clinical Study Report date: June 2018 Publication date: 2018, 2018, 2019,2020
Methodology:
Inclusion criteria
- Age between 45 and 60 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)
Exclusion criteria Known oversensitiveness, chronic renal disease (GFR<60 ml/min) or ESRD, heart or respiratory failure, recent MI, shock and pregnancy or lactation.
Study drugs:
Clinical examination 0,1,6,12,24,36 months.
- Duration and follow-up: 3 years
- Collected data: Ambulatory blood pressure monitoring, 24h SBP and DBP in time 0,12, 24 months.
- BMI, waist/hip ratio in time 0, 12, 24,36 months.
- HbA1c, insulin in time 0, 1, 6,12, 24,36 months.
- K, Na, Cr, BUN, Chol, Tg, HDL, LDL,ALT, AST in time 0, 1, 6,12, 24,36 months.
Number of patients: 1054
Sample size justification:
The reduction in mean 24h SBP expected to be 2.5 mmHg. Previous studies from our group reported an 12-14mmHg SD for 24h mean SBP. The sample size required at the two sided 5% significance level and 90% power is 527 patients per drug arm.
Statistics/Data Analysis Stata Estimated sample size for two-sample comparison of means Test Ho: m1 = m2, where m1 is the mean in population 1 and m2 is the mean in population 2
Assumptions:
alpha = 0.0500 (two-sided) power = 0.9000 m1 = 130 m2 = 132.5 sd1 = 12 sd2 = 13 n2/n1 = 1.00
Estimated required sample sizes:
n1 = 527 n2 = 527
Population: Diabetes, prehypertension, outpatients. I
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: Metformin527 Patients treated with Metformin 850x2mg titrated to 1000x2mg Daily oral |
| Empagliflozin | Active comparator | Drug: empagliflozin527 Patients treated with empagliflozin 10mg titrated to 25 mg Daily oral |
Who may qualify
- Ages
- 45 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (4 listed)
- Known oversensitiveness
- chronic renal disease (GFR<60 ml/min) or ESRD
- heart or respiratory failure, recent MI, shock
- pregnancy or lactation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| empagliflozinAlso: JARDIANCEACTIVE TREATMENT FOR DIABETES | Drug | Empagliflozin |
| MetforminAlso: GLUCOPHAGEACTIVE TREATMENT FOR DIABETES | Drug | Metformin |
Primary outcome
New onset of hypertension
Time frame: 36 months
6 secondary outcomes
24h blood pressure levels
Time frame: 36 months
Total cardiovascular risk
Time frame: 36 months
Morbidity cardiovascular
Time frame: 36 months
Arterial stiffness
Time frame: 36 months
Central aortic blood pressure
Time frame: 36 months
Mortality cardiovascular
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Apr 2015.
- Derived from this study: PubMed 32501595Gnesin 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing empagliflozin and Metformin in people with Hypertension and Type II Diabetes, run by Aristotle University Of Thessaloniki at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact VASILEIOS KOTSIS, PROF (+306974748860, vkotsis@auth.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
New onset of hypertension (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01001962, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Apr 2015.