Effects of Empagliflozin on Left Ventricular Diastolic Function Compared to Usual Care in Type 2 Diabetics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

144 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-10-10

Study Completion Date

2020-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of the EmDia trial is to compare the effects of empagliflozin with placebo in addition to standard diabetic treatment or dietetic treatment on cardiac diastolic function in patients with type 2 Diabetes mellitus.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

SGLT2 Inhibition and Left Ventricular Mass

NCT02728453

Diabetes Mellitus Type 2

TERMINATED PHASE4

Empagliflozin as a Modulator of Systemic Vascular Resistance and Cardiac Output in Patients With Type 2 Diabetes

NCT03132181

Diabetes Mellitus Type 2 (T2DM)

COMPLETED PHASE2

Effects of Empagliflozin on Cardiac Structure in Patients With Type 2 Diabetes

NCT02998970

Diabetes Cardiovascular Disease

UNKNOWN PHASE4

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

NCT01001962

Hypertension Type II Diabetes

UNKNOWN PHASE4

Studies of Empagliflozin and Its Cardiovascular, Renal and Metabolic Effects

NCT03485092

Heart Failure Diabetes Mellitus

COMPLETED PHASE4

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Diabetes is a serious and increasing global health burden. It has been shown, that diabetes is associated with a two-fold higher risk for coronary heart disease, stroke and for the aggregate of other vascular death independently of other conventional risk factors. It is the leading cause of cardiovascular disease.

Diabetes mellitus substantially increases the risk of macrovascular and microvascular complications, such as vascular dysfunction with developing coronary, cerebrovascular, and peripheral arterial disease, heart failure, nerve disorders (neuropathy), eye complications (e.g. cataracts, glaucoma diabetic retinopathy), kidney disease (nephropathy), foot ulcers, restriction of mental function, and psychosomatic diseases (e.g. stress, anxiety and depression).

The most common of the cardiovascular complications in diabetics are ischemic cardiomyopathy and left ventricular (LV) dysfunction. Of particular interest here is the diastolic dysfunction, as an early sign of diabetic heart muscle disease followed by systolic damage.

Although diabetes has a decisive role in the development of cardiovascular disease, traditional glucose lowering agents have failed to convincingly show that intensive glucose control significantly reduces CVD events.

A new approach for treatment of adult patients with type 2 diabetes was found with the selective inhibition of sodium glucose cotransporter 2 (SGLT2). Studies have shown that empagliflozin, a potent SGLT2 inhibitor, not only effectively reduces the rates of hyperglycemia but also blood pressure and weight. (16, 18) In addition, beneficial effects on arterial stiffness and vascular resistance, visceral adiposity, albuminuria and plasma urate have been reported.

The results of the EMPA-REG OUTCOME study suggest that empagliflozin added to the standard therapy has a positive influence on cardiovascular outcomes and heart failure hospitalization in individuals with diabetic mellitus.

The aim of the present study is to investigate the effects of empagliflozin, in comparison with placebo, on cardiac and vascular function as well as on cardiac biomarker in individuals with type 2 diabetes with standard therapy, increased E/E' ratio and poor glycemic control.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Diabetes Mellitus, Type 2 Diastolic Dysfunction

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Empagliflozin

10 mg Empagliflozin daily per os for 12 weeks

Group Type EXPERIMENTAL

Empagliflozin

Intervention Type DRUG

10 mg per os daily for 12 weeks

Placebo

amount of Placebo corresponding to empagliflozin 10 mg daily per os for 12 weeks

Group Type EXPERIMENTAL

Placebo

Intervention Type DRUG

amount of Placebo corresponding to empagliflozin 10 mg per os daily for 12 weeks

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Empagliflozin

10 mg per os daily for 12 weeks

Intervention Type DRUG

Placebo

amount of Placebo corresponding to empagliflozin 10 mg per os daily for 12 weeks

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Jardiance

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

Subjects meeting all of the following criteria at visit 0 (screening) will be considered for admission to the trial:

* Diagnosis of type 2-diabetes mellitus with stable glucose-lowering background therapy and/or dietetic treatment for at least 12 weeks
* In subjects without glucose-lowering background therapy: the application of Metformin was considered to be unsuitable due to drug intolerance
* HbA1c level of ≥6.5% and ≤10.0% at visit 0 (screening) for subjects on antidiabetic background therapy or HbA1c level of ≥6.5% and ≤9.0% for drug-naïve subjects with dietetic treatment
* Diastolic cardiac dysfunction E/E' ratio ≥8 (2D-echocardiography)
* Age 18 - 84 years
* BMI ≤ 45 kg/m² (Body Mass Index)
* For women: post-menopausal for more than 12 months without an alternative medical cause can participate in the trial. Women with childbearing potential can only participate, if they are surgically sterile or a negative pregnancy test (serum or urine) is available at visit 1 and they are willing to practice highly effective birth control method during trial. Reliable highly effective contraception comprises

* combined (estrogen and progesteron containing) hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
* progesteron-only hormonal contraception associated with inhibition of ovaluation (oral, injectable, implantable)
* intrauterine device (IUD)
* intrauterine hormone-releasing system (IUS)
* bilateral tubal occlusion
* vasectomised partner (provided that partner is the sole sexual partner and that the vasectomised partner has received medical assessment of the surgical success)
* sexual abstinence (defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatment. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the subject.
* Ability of subject to understand nature, importance and individual consequences of clinical trial
* Signed and dated informed consent of the subject must be available before start of any specific trial procedures which is consistent with ICH-GCP guidelines and local legislation

Exclusion Criteria

Subjects presenting with any of the following criteria at visit 0 (screening) will not be included in the trial:

* Pretreatment with empagliflozin or other SGLT2 inhibitor within the last 3 months
* Pretreatment with known inducers of UGT enzymes
* Uncontrolled hyperglycemia with a glucose level \> 240 mg/dl (\>13.3 mmol/L) after an overnight fast
* Impaired renal function, defined as eGFR \<45 ml/min/1.73 m² of body-surface-area
* End-stage renal failure or dialysis
* Severe hepatic dysfunction, defined by serum levels of either SGPT, SGOT, or alkaline phosphatase above 3 x upper limit of normal (ULN)
* Acute urinary tract infection (UTI)
* Known acute genital infection (GI)
* Symptomatic hypotension
* Hematocrit above the upper limit of the reference range
* Hypoglycemic tendencies
* Severe PAD (Fontaine classification Stage IIb - IV)
* Medical history of cancer and/or treatment for cancer within the last 5 years, subjects basalioma can be included in the study
* Medical history of pancreatitis or surgery on pancreas
* Known ketoacidosis (in the past)
* Acute febrile disease
* NYHA classification III - IV
* Pregnant and/or nursing women at visit 1 (baseline)
* Acute coronary syndrome, stroke or TIA within the last 2 months
* Planned cardiac surgery or angioplasty within 3 months
* Gastrointestinal surgeries that induce chronic malabsorption
* Blood dyscrasia or any disorders causing hemolysis or unstable Red Blood Cells (e.g. malaria, babesiosis, hemolytic anemia)
* History of hypersensitivity to the investigational medicinal product or to any drug with similar chemical structure or to any excipient present in the pharmaceutical form of the investigational medicinal product
* Alcohol or drug abuse within the last 3 months that would interfere with trial participation
* Medical or psychological conditions that would jeopardize an adequate and orderly completion of the trial (at visit 0 (screening) or at visit 1 (baseline))
* Medical condition that does not allow enrollment in the trial at visit 1 (baseline)
* Current treatment with systemic steroids or change in dosage of thyroid hormones within the last 6 weeks or any other uncontrolled endocrine disorder except type 2 diabetes mellitus
* Hereditary glucose intolerance, galactose intolerance, Lapp-lactase deficiency or glucose-galactose-malabsorption
* Intake of an investigational drug in another trial within 30 days prior to intake of study medication in this trial or participating in another trial (involving an investigational drug and/or follow-up)

Minimum Eligible Age

18 Years

Maximum Eligible Age

84 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No