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

NCT ID: NCT01001962

Last Updated: 2015-04-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 1054 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2020-01-31

Brief 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. 3 years morbidity and mortality rates

5. 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

1. Age between 45 and 60 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 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Metformin

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

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

ACTIVE TREATMENT FOR DIABETES

Empagliflozin

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

Group Type: ACTIVE_COMPARATOR

empagliflozin

Intervention Type: DRUG

ACTIVE TREATMENT FOR DIABETES

Interventions

empagliflozin

ACTIVE TREATMENT FOR DIABETES

Intervention Type: DRUG

Metformin

ACTIVE TREATMENT FOR DIABETES

Intervention Type: DRUG

Other Intervention Names

JARDIANCE; GLUCOPHAGE

Eligibility Criteria

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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Aristotle University Of Thessaloniki

OTHER

Sponsor Role: lead

Responsible Party

Vasilios Kotsis

Prof. Med

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Hypertension 24h ABPM center Papageorgiou Hospital

Thessaloniki, , Greece

Countries

Greece

Central Contacts

VASILEIOS KOTSIS, PROF

Role: CONTACT

vkotsis@auth.gr

+306974748860

Facility Contacts

VASILEIOS KOTSIS, PROF

Role: primary

References

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.

Reference Type: DERIVED

PMID: 32501595 (View on PubMed)

Other Identifiers

PREHYPERTENSION

Identifier Type: -

Identifier Source: org_study_id