Diabetes Mellitus, Type 2Phase 4EmDiaNCT02932436
Effects of Empagliflozin on Left Ventricular Diastolic Function Compared to Usual Care in Type 2 Diabetics
A Phase 4 study testing Empagliflozin in people with Diabetes Mellitus, Type 2 and Diastolic Dysfunction, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Diastolic Dysfunction
- What is being tested?
- Empagliflozin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 144 participants
- Where
- 1 siteGermany
- Study dates
- 10 Oct 2016to 31 Aug 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 18 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 17Show fewer
- 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
Who cannot join
- 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
Show all 30Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Zentrum für Kardiologie, Präventive Kardiologie und Medizinische Prävention
Mainz, 55131
About this study
Official title: A Phase IV, Single-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study on the Effects of Empagliflozin on Left Ventricular Diastolic Function Compared to Usual Care in Individuals With Type 2 Diabetes
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.
Read the detailed description
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
- Diabetes Mellitus, Type 2, Diastolic Dysfunction
- Being tested
- Empagliflozin, Placebo
- Keywords
- empagliflozin, diastolic function, poorly controlled type 2 diabetes mellitus
- Medical subject headings
- 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
10 mg per os daily for 12 weeks
PlaceboDrug
amount of Placebo corresponding to empagliflozin 10 mg per os daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | 10 mg Empagliflozin daily per os for 12 weeks Receives: Drug: Empagliflozin |
| Placebo | Experimental | amount of Placebo corresponding to empagliflozin 10 mg daily per os for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
difference in E/E' ratio between 12 weeks after baseline and at baseline
difference in E/E' ratio (noninvasive surrogate marker for left ventricular diastolic function (LVEDP) measured by 2D-echocardiography) between 12 weeks after baseline and at baseline
Measured: 12 weeks
Secondary outcomes (21)
difference in E/E' ratio (change from baseline (V1) to 1 week follow-up)
difference in E/E' ratio (change from baseline (V1) to 1 week follow-up (2D-echocardiography)
Measured: 1 week
difference in Left ventricular systolic function (LVEF)
difference in Left ventricular systolic function (LVEF) from baseline to week 1
Measured: 1 week
difference in Left ventricular systolic function (LVEF)
difference in Left ventricular systolic function (LVEF) from baseline to week 12
Measured: 12 weeks
difference in Left end-diastolic volume (LEDV)
difference in Left end-diastolic volume (LEDV) from baseline to week 1
Measured: 1 week
difference in Left end-diastolic volume (LEDV)
difference in Left end-diastolic volume (LEDV) from baseline to week 12
Measured: 12 weeks
difference in Carotid-femoral pulse wave velocity
difference in Carotid-femoral pulse wave velocity (cf-PWV, vascular explorer - calculated) from baseline to week 1
Measured: 1 week
difference in Carotid-femoral pulse wave velocity
difference in Carotid-femoral pulse wave velocity (cf-PWV, vascular explorer - calculated) from baseline to week 12
Measured: 12 weeks
difference in Augmentation index (AIx)
difference in Augmentation index (AIx, vascular explorer) from baseline to week 1
Measured: 1 week
difference in Augmentation index (AIx)
difference in Augmentation index (AIx, vascular explorer) from baseline to week 12
Measured: 12 week
difference in Arterial stiffness index (SI)
difference in Arterial stiffness index (SI, photo plethysmography) from baseline to week 1
Measured: 1 week
difference in Arterial stiffness index (SI)
difference in Arterial stiffness index (SI, photo plethysmography) from baseline to week 12
Measured: 12 weeks
difference in Reflection index
difference in Reflection index (photo plethysmography) from baseline to week 1
Measured: 1 week
difference in Reflection index
difference in Reflection index (photo plethysmography) from baseline to week 12
Measured: 12 weeks
difference in Brain natriuretic peptide (BNP)
difference in Brain natriuretic peptide (BNP) from baseline to week 1
Measured: 1 week
difference in Brain natriuretic peptide (BNP)
difference in Brain natriuretic peptide (BNP) from baseline to week 12
Measured: 12 weeks
difference in High sensitive troponin I (hs TnI)
difference in High sensitive troponin I (hs TnI) from baseline to week 1
Measured: 1 week
difference in High sensitive troponin I (hs TnI)
difference in High sensitive troponin I (hs TnI) from baseline to week 12
Measured: 12 weeks
difference in High sensitive C-reactive protein (hs CRP)
difference in High sensitive C-reactive protein (hs CRP) from baseline to week 1
Measured: 1 week
difference in High sensitive C-reactive protein (hs CRP)
difference in High sensitive C-reactive protein (hs CRP) from baseline to week 12
Measured: 12 weeks
difference in E/E' ratio (change from baseline (V1) to 12 weeks follow-up) in the subgroup of patients with eGFR 45-59 ml/min/1.73 m²
difference in E/E' ratio (noninvasive surrogate marker for left ventricular diastolic function (LVEDP) measured by 2D-echocardiography) between 12 weeks after baseline and at baseline in the subgroup of patients with eGFR 45-59 ml/min/1.73 m²
Measured: 12 weeks
difference in E/E' ratio (change from baseline (V1) to 12 weeks follow-up) in the subgroup of patients with HbA1c 6.5%-6.9%
difference in E/E' ratio (noninvasive surrogate marker for left ventricular diastolic function (LVEDP) measured by 2D-echocardiography) between 12 weeks after baseline and at baseline in the subgroup of patients with with HbA1c 6.5%-6.9%
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2016 (estimated)
- Study start10 Oct 2016
- Primary completion15 Jun 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 144 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Principal investigator, Philipp Wild, MD, MSc, Johannes Gutenberg University Mainz
- Investigators
- Philipp Wild, MD, MSc, Principal investigator, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02932436
- Sponsor's protocol ID
- UMCM-2016EPI05
- Other IDs
- 2016-001264-11, 2016
- Acronym
- EmDia
- Status last verified
- Apr 2021
- First submitted
- 12 Oct 2016
- Last updated
- 19 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Schmitt F, Ten Cate V, Fischer Z, Hagen M, Steigenberger BA, Tenzer S, Wild PS, Schmidlin T. Metabolic Profiling of the EmDia Cohort by LC-MS Reveals Empagliflozin-Intake Associated Regulation of 1,5-anhydroglucitol and Urate. Proteomics. 2026 Jan;26(1):44-56. doi: 10.1002/pmic.70075. Epub 2025 Dec 3.
PubMed 41334707Bauer KI, Baker D, Lerner R, Koeck T, Buch G, Fischer Z, Martens R, Esenkova EE, Nuber M, Andrade-Navarro MA, Ten Cate V, Tenzer S, Wild PS, Bindila L, Araldi E. Effect of Empagliflozin on the plasma lipidome in patients with type 2 diabetes mellitus: results from the EmDia clinical trial. Cardiovasc Diabetol. 2025 Sep 8;24(1):359. doi: 10.1186/s12933-025-02916-0.
PubMed 40922034Prochaska JH, Junger C, Schulz A, Arnold N, Muller F, Heidorn MW, Baumkotter R, Zahn D, Koeck T, Trobs SO, Lackner KJ, Daiber A, Binder H, Shah SJ, Gori T, Munzel T, Wild PS. Effects of empagliflozin on left ventricular diastolic function in addition to usual care in individuals with type 2 diabetes mellitus-results from the randomized, double-blind, placebo-controlled EmDia trial. Clin Res Cardiol. 2023 Jul;112(7):911-922. doi: 10.1007/s00392-023-02164-w. Epub 2023 Feb 10.
PubMed 36763159Junger C, Prochaska JH, Gori T, Schulz A, Binder H, Daiber A, Koeck T, Rapp S, Lackner KJ, Munzel T, Wild PS. Rationale and design of the effects of EMpagliflozin on left ventricular DIAstolic function in diabetes (EmDia) study. J Cardiovasc Med (Hagerstown). 2022 Mar 1;23(3):191-197. doi: 10.2459/JCM.0000000000001267.
PubMed 34939776
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase IV, Single-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study on the Effects of Empagliflozin on Left Ventricular Diastolic Function Compared to Usual Care in Individuals With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT02932436
- Acronym / sponsor ID
- EmDia / UMCM-2016EPI05
- Conditions
- Diabetes Mellitus, Type 2, Diastolic Dysfunction
- Keywords
- empagliflozin, diastolic function, poorly controlled type 2 diabetes mellitus
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 144 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 10 Oct 2016 (actual)
- Primary completion
- 15 Jun 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 13 Oct 2016 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Empagliflozin | Experimental | Drug: Empagliflozin10 mg Empagliflozin daily per os for 12 weeks |
| Placebo | Experimental | Drug: Placeboamount of Placebo corresponding to empagliflozin 10 mg daily per os for 12 weeks |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- 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)
Key exclusion criteria (30 listed)
- 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
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: Jardiance10 mg per os daily for 12 weeks | Drug | Empagliflozin |
| Placeboamount of Placebo corresponding to empagliflozin 10 mg per os daily for 12 weeks | Drug | Placebo |
Primary outcome
difference in E/E' ratio between 12 weeks after baseline and at baseline
Time frame: 12 weeks
difference in E/E' ratio (noninvasive surrogate marker for left ventricular diastolic function (LVEDP) measured by 2D-echocardiography) between 12 weeks after baseline and at baseline
21 secondary outcomes
difference in E/E' ratio (change from baseline (V1) to 1 week follow-up)
Time frame: 1 week
difference in Left ventricular systolic function (LVEF)
Time frame: 1 week
difference in Left ventricular systolic function (LVEF)
Time frame: 12 weeks
difference in Left end-diastolic volume (LEDV)
Time frame: 1 week
difference in Left end-diastolic volume (LEDV)
Time frame: 12 weeks
difference in Carotid-femoral pulse wave velocity
Time frame: 1 week
difference in Carotid-femoral pulse wave velocity
Time frame: 12 weeks
difference in Augmentation index (AIx)
Time frame: 1 week
difference in Augmentation index (AIx)
Time frame: 12 week
difference in Arterial stiffness index (SI)
Time frame: 1 week
difference in Arterial stiffness index (SI)
Time frame: 12 weeks
difference in Reflection index
Time frame: 1 week
difference in Reflection index
Time frame: 12 weeks
difference in Brain natriuretic peptide (BNP)
Time frame: 1 week
difference in Brain natriuretic peptide (BNP)
Time frame: 12 weeks
difference in High sensitive troponin I (hs TnI)
Time frame: 1 week
difference in High sensitive troponin I (hs TnI)
Time frame: 12 weeks
difference in High sensitive C-reactive protein (hs CRP)
Time frame: 1 week
difference in High sensitive C-reactive protein (hs CRP)
Time frame: 12 weeks
difference in E/E' ratio (change from baseline (V1) to 12 weeks follow-up) in the subgroup of patients with eGFR 45-59 ml/min/1.73 m²
Time frame: 12 weeks
difference in E/E' ratio (change from baseline (V1) to 12 weeks follow-up) in the subgroup of patients with HbA1c 6.5%-6.9%
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2021.
- Derived from this study: PubMed 41334707Schmitt F, Ten Cate V, Fischer Z, Hagen M, Steigenberger BA, Tenzer S, Wild PS, Schmidlin T. Metabolic Profiling of the EmDia Cohort by LC-MS Reveals Empagliflozin-Intake Associated Regulation of 1,5-anhydroglucitol and Urate. Proteomics. 2026 Jan;26(1):44-56. doi: 10.1002/pmic.70075. Epub 2025 Dec 3.
- Derived from this study: PubMed 40922034Bauer KI, Baker D, Lerner R, Koeck T, Buch G, Fischer Z, Martens R, Esenkova EE, Nuber M, Andrade-Navarro MA, Ten Cate V, Tenzer S, Wild PS, Bindila L, Araldi E. Effect of Empagliflozin on the plasma lipidome in patients with type 2 diabetes mellitus: results from the EmDia clinical trial. Cardiovasc Diabetol. 2025 Sep 8;24(1):359. doi: 10.1186/s12933-025-02916-0.
- Derived from this study: PubMed 36763159Prochaska JH, Junger C, Schulz A, Arnold N, Muller F, Heidorn MW, Baumkotter R, Zahn D, Koeck T, Trobs SO, Lackner KJ, Daiber A, Binder H, Shah SJ, Gori T, Munzel T, Wild PS. Effects of empagliflozin on left ventricular diastolic function in addition to usual care in individuals with type 2 diabetes mellitus-results from the randomized, double-blind, placebo-controlled EmDia trial. Clin Res Cardiol. 2023 Jul;112(7):911-922. doi: 10.1007/s00392-023-02164-w. Epub 2023 Feb 10.
- Derived from this study: PubMed 34939776Junger C, Prochaska JH, Gori T, Schulz A, Binder H, Daiber A, Koeck T, Rapp S, Lackner KJ, Munzel T, Wild PS. Rationale and design of the effects of EMpagliflozin on left ventricular DIAstolic function in diabetes (EmDia) study. J Cardiovasc Med (Hagerstown). 2022 Mar 1;23(3):191-197. doi: 10.2459/JCM.0000000000001267.
- Individual participant dataSharing planned: Undecided
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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.
Philipp Wild, MD, MSc principal investigator
Johannes Gutenberg University Mainz
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 in people with Diabetes Mellitus, Type 2 and Diastolic Dysfunction, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 17 inclusion and 30 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: finished, as of the sponsor's last update on 19 Apr 2021. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
difference in E/E' ratio between 12 weeks after baseline and at baseline (time frame: 12 weeks). 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 NCT02932436, which also lists 4 linked publications.
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 19 Apr 2021.