Diabetes Mellitus Type 2Phase 4EMPATROPHYNCT02728453
SGLT2 Inhibition and Left Ventricular Mass
A Phase 4 study testing Empagliflozin and Glimepiride in people with Diabetes Mellitus Type 2, run by Hannover Medical School at 1 site in Germany.
Trial summary
Patients with type 2 diabetes mellitus are exposed to an excessive heart failure risk secondary to left ventricular hypertrophy and impaired diastolic filling, a condition not addressed by currently available treatments. Read more about this study
- Who is it for?
- Ages 40 to 79 years
- Conditions the study is for
- Diabetes Mellitus Type 2
- What is being tested?
- Empagliflozin and Glimepiride
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- 27 Apr 2016to 27 Sep 2017
- 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 40 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- women and men ≥40 and <80 years of age
- patients with type 2 diabetes mellitus on stable anti-diabetic treatment for the last 3 months; at screening the following treatment conditions are allowed:
- metformin + sulfonylurea with HbA1c ≥6.5% and ≤9.0%
- metformin monotherapy with HbA1c ≥7.5% and ≤ 9.0%
- metformin + dipeptidylpeptidase-IV inhibitor with ≥6.5% and ≤9.0%
- waist circumference ≥80 cm in women or ≥94 cm in men
Show all 19Show fewer
- office blood pressure ≤150/95 mm Hg with a stable dose of a maximum of 4 antihypertensive medications for the last 3 months (24h ambulatory blood pressure measurement (ABPM) is allowed to check accuracy of office values; inclusion with 24h mean blood pressure ≤145/90 mm Hg is possible)
- women without childbearing potential defined by:
- at least 6 weeks after surgical sterilization by bilateral tubal ligation or bilateral oophorectomy
- hysterectomy
- ≥ 50 years and in postmenopausal state > 1 year
- < 50 years and in postmenopausal state > 1 year with serum follicle-stimulating Hormone (FSH) > 40 IU/l and serum estrogen < 30 ng/l or a negative estrogen test, both at screening
- women of childbearing potential with a negative serum pregnancy test at screening who agree to meet one of the following criteria from the time of screening, during the study and for a period of 4 days following the last administration of study medication:
- correct use of reliable contraception methods. The following are acceptable: hormonal contraceptives (combined oral contraceptives, implants, transdermal patches, hormonal vaginal devices or injections with prolonged release), intrauterine device (IUD/IUS) or a double barrier method, e.g. condom and occlusive cap (diaphragm or cervical/vault caps) with spermicide (foam, gel, film, cream or suppository)
- true abstinence (periodic abstinence and withdrawal are not acceptable methods of contraception)
- sexual relationship only with female partners
- sterile male partners
- signed written informed consent and willingness to comply with treatment and follow-up
- capability of understanding the investigational nature, potential risks and benefits of the clinical trial
Who cannot join
- diabetes mellitus type 1
- uncontrolled diabetes mellitus type 2 with fasting glucose > 13.3 mmol/l confirmed on a second day
- previous treatment with insulin, glucagon-like peptide-1 analogues, or pioglitazone during the last year before screening
- previous treatment with empagliflozin
- acute illness at screening or randomization according to judgement by the investigator or patient
- known or suspected hypersensitivity to empagliflozin, glimepiride or any excipients; known or suspected hypersensitivity to sulfonylureas or sulfonamides
Show all 32Show fewer
- history of multiple severe hypoglycemic episodes
- any condition prohibiting MRI studies (e.g. metal implants, claustrophobia, body weight too high) including any suspected reaction after contrast agent application
- patient actively attempted to lose weight or experienced unintentional clinically significant weight loss during the last 3 months
- bariatric surgery or other gastrointestinal surgery procedures that induce chronic malabsorption
- treatment with any weight loss drug in the preceding 6 months
- planned significant changes of pre-study physical activity level during study participation
- heart failure New York Heart Association (NYHA) III - IV
- patients with known severe cardiovascular disease (e.g. myocardial infarction, unstable angina, stable coronary artery disease, stroke or transient ischemic attack)
- calculated glomerular filtration rate (eGFR) <60 ml/min/1,73 m2
- treatment with loop diuretics
- chronic diarrhea, any clinical signs of volume depletion or a haematocrit > 48 % (women) and > 53 % (men)
- history of severe volume depletion that required medical therapy
- chronic lower urinary tract infections (but not simple asymptomatic bacteriuria)
- known acute or chronic liver disease or screening liver enzymes > 3 x upper limit of normal (ULN)
- serum potassium < 3.6 or > 5.0 mmol/l
- glucose-6-phosphate dehydrogenase deficiency
- anemia of unknown origin
- pregnancy or lactation period
- treatment with systemic glucocorticoids during the last 3 months before screening
- chronic treatment with non-steroidal anti-inflammatory drugs (NSAIDs)
- changes in thyroid hormone dosage (stable doses of thyroid hormones for the last 3 months are acceptable)
- history of drug or alcohol abuse or current abuse
- psychosomatic or psychiatric diseases requiring hospitalization during the last 12 months; ongoing treatment with one tricyclic or selective serotonin re-uptake Inhibitor (SSRI) antidepressant drug at a stable dose since the last 3 months is acceptable except for fluoxetine
- medical history of cancer except for strictly localized tumors
- any medical or surgical intervention planned for the next 7 months after randomization not allowing study participation according to the investigator´s judgment
- current participation in any other clinical trial or participation in another clinical trial within 30 days before screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: SGLT2 Inhibition With Empagliflozin in Patients With Type 2 Diabetes Mellitus: Influences on Left Ventricular Mass, Function, and Cardiac Lipid Content
Patients with type 2 diabetes mellitus are exposed to an excessive heart failure risk secondary to left ventricular hypertrophy and impaired diastolic filling, a condition not addressed by currently available treatments. The abnormality results from obesity-induced volume overload, increased blood pressure, and myocardial fat accumulation. By improving metabolism, body weight, and blood pressure, Empagliflozin addresses the root causes of type 2 diabetes-associated myocardial disease. We will assess left ventricular mass, function, and lipid content in patients with type 2 diabetes mellitus using cardiac magnetic resonance imaging and spectroscopy as well as echocardiography before and after empagliflozin or glimepiride treatment. We expect to observe improvements in left ventricular mass, function, and fat content with empagliflozin. The results of the study will help to position empagliflozin as an antidiabetic agent with the added value of protecting the heart.
Read the detailed description
Overview of Medical Indication Type 2 diabetes mellitus is associated with increased heart failure risk. The increased risk results in part from poor glycemic control and obesity, but concomitant arterial hypertension may also contribute. In the Framingham Heart Study, heart failure risk increased by 5% in men and by 7% in women with each 1 kg/m2 increment in body mass index (BMI). Compared with normal weight subjects, obese subjects had a doubling of heart failure risk. Given the rapid increase in the prevalence of obesity and type 2 diabetes mellitus, the number of heart failure patients is likely to increase sharply.
Evidence Heart failure in obesity is explained by increased left ventricular mass and impaired left ventricular diastolic filling rather than systolic dysfunction. Obesity is associated with volume expansion and increased cardiac output. Arterial blood pressure also increases with increasing obesity. In addition, type 2 diabetes mellitus may directly elicit abnormalities in myocardial metabolism and function through intramyocardial triglyceride deposition and lipotoxicity. In a study from our group, obese women with insulin resistance showed increased myocardial lipid accumulation compared with obese insulin-sensitive women, and intramyocardial lipids were reduced by dietary weight loss. Finally, intramyocardial lipids are associated with impaired diastolic function in patients with type 2 diabetes mellitus. Myocardial insulin resistance may also contribute to heart failure, because genetic deletion of cardiac insulin receptors in mice worsens catecholamine-mediated myocardial injury. Heart failure risk may be further exacerbated through obesity-induced neurohumoral activation and systemic inflammation. Inflammatory cytokines are elevated in heart failure and modulate cardiac remodelling through various mechanisms including myocardial hypertrophy, fibrosis, and apoptosis.
Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a new drug class for the treatment of type 2 diabetes mellitus. SGLT2 inhibitors may be particularly suitable in improving cardiac structure and function because they substantially improve systemic glucose metabolism, lower blood pressure, and reduce body weight. These effects reduce sympathetic vasomotor tone, and renin-angiotensin-system activity. Thus, SGLT2 inhibitors including empagliflozin ameliorate metabolic and hemodynamic risk factors tightly linked with left ventricular hypertrophy and heart failure risk. Recently published outcome data suggest a beneficial effect of empagliflozin on heart failure hospitalisation rates and on overall cardiovascular mortality in patients with type 2 diabetes and previously diagnosed cardiovascular disease.
Study Rationale Patients with type 2 diabetes mellitus are exposed to an excessive heart failure risk secondary to left ventricular hypertrophy and impaired diastolic filling, a condition not addressed by currently available treatments. The abnormality results from obesity-induced volume overload, increased blood pressure, and myocardial fat accumulation. By improving metabolism, body weight, and blood pressure, empagliflozin addresses the root causes of myocardial disease associated with type 2 diabetes-. We will assess left ventricular mass, function, and lipid content in patients with type 2 diabetes mellitus before and after 24 weeks treatment with metformin plus empagliflozin or glimepiride. We expect to observe improvements in left ventricular mass, function, and fat content with empagliflozin. The results of the study will help to understand the mechanisms of cardioprotective effects of empagliflozin that have been revealed recently.
- Conditions
- Diabetes Mellitus Type 2
- Being tested
- Empagliflozin, Glimepiride
- 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
Treatment with empagliflozin vs. glimepiride to understand whether empagliflozin may reduce left ventricular mass in patients with type 2 Diabetes mellitus.
GlimepirideDrug
Also called Amaryl
Treatment with empagliflozin vs. glimepiride to understand whether empagliflozin may reduce left ventricular mass in patients with type 2 Diabetes mellitus.
| Study group | Role | What they receive |
|---|---|---|
| Empagliflozin | Experimental | 25 mg/d empagliflozin + matching glimepiride placebo for 24 weeks. Receives: Drug: Empagliflozin |
| Glimepiride | Active comparator | 2 or 4 mg/d glimepiride+ matching empagliflozin placebo for 24 weeks. Receives: Drug: Glimepiride |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in left ventricular mass
change in left ventricular mass determined by cardiac MRI as the difference between 24 weeks and baseline
Measured: baseline and 24 weeks
Secondary outcomes (12)
change in left ventricular end-systolic volume
change in left ventricular end-systolic volume (cMRI, 24 weeks - baseline)
Measured: baseline and 24 weeks
change in left ventricular function
change in left ventricular function (cMRI, 24 weeks - baseline)
Measured: baseline and 24 weeks
change in intramyocardial lipid content
change in intramyocardial lipid content (cMR spectroscopy, 24 weeks - baseline)
Measured: baseline and 24 weeks
change in diastolic function
change in diastolic function (echocardiography, 24 weeks - baseline)
Measured: baseline and 24 weeks
change in HbA1c
change in HbA1c (24 weeks - baseline)
Measured: baseline and 24 weeks
change in fasting plasma glucose concentration
change in fasting plasma glucose concentration (24 weeks - baseline)
Measured: baseline and 24 weeks
change in body weight
change in body weight (24 weeks - baseline)
Measured: baseline and 24 weeks
change ambulatory blood pressure
change in ambulatory blood pressure (24 weeks - baseline)
Measured: baseline and 24 weeks
change in left ventricular end-diastolic volume
change in left ventricular end-diastolic volume (cMRI, 24 weeks - baseline)
Measured: baseline and 24 weeks
change in fasting serum insulin concentration
change in fasting serum insulin concentration (24 weeks - baseline)
Measured: baseline and 24 weeks
change in waist circumference
change in waist circumference (24 weeks - baseline)
Measured: baseline and 24 weeks
change in body fat mass
change in body fat mass (24 weeks - baseline)
Measured: baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2016 (estimated)
- Study start27 Apr 2016
- Primary completion25 Sep 2017
- Study completion27 Sep 2017
Why it stopped: Insufficient recruitment.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- Boehringer Ingelheim
- Responsible party
- Sponsor
- Investigators
- Jens Jordan, Prof. Dr., Principal investigator, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02728453
- Sponsor's protocol ID
- CRC-KliPha-001
- Acronym
- EMPATROPHY
- Status last verified
- Jun 2018
- First submitted
- 24 Mar 2016
- Last updated
- 22 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SGLT2 Inhibition With Empagliflozin in Patients With Type 2 Diabetes Mellitus: Influences on Left Ventricular Mass, Function, and Cardiac Lipid Content
- ClinicalTrials.gov ID
- NCT02728453
- Acronym / sponsor ID
- EMPATROPHY / CRC-KliPha-001
- Conditions
- Diabetes Mellitus Type 2
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- Boehringer Ingelheim
- Study start
- 27 Apr 2016 (actual)
- Primary completion
- 25 Sep 2017 (actual)
- Study completion
- 27 Sep 2017 (actual)
- First posted
- 5 Apr 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.
Patients with type 2 diabetes mellitus are exposed to an excessive heart failure risk secondary to left ventricular hypertrophy and impaired diastolic filling, a condition not addressed by currently available treatments. The abnormality results from obesity-induced volume overload, increased blood pressure, and myocardial fat accumulation. By improving metabolism, body weight, and blood pressure, Empagliflozin addresses the root causes of type 2 diabetes-associated myocardial disease. We will assess left ventricular mass, function, and lipid content in patients with type 2 diabetes mellitus using cardiac magnetic resonance imaging and spectroscopy as well as echocardiography before and after empagliflozin or glimepiride treatment. We expect to observe improvements in left ventricular mass, function, and fat content with empagliflozin. The results of the study will help to position empagliflozin as an antidiabetic agent with the added value of protecting the heart.
Detailed description
Overview of Medical Indication Type 2 diabetes mellitus is associated with increased heart failure risk. The increased risk results in part from poor glycemic control and obesity, but concomitant arterial hypertension may also contribute. In the Framingham Heart Study, heart failure risk increased by 5% in men and by 7% in women with each 1 kg/m2 increment in body mass index (BMI). Compared with normal weight subjects, obese subjects had a doubling of heart failure risk. Given the rapid increase in the prevalence of obesity and type 2 diabetes mellitus, the number of heart failure patients is likely to increase sharply.
Evidence Heart failure in obesity is explained by increased left ventricular mass and impaired left ventricular diastolic filling rather than systolic dysfunction. Obesity is associated with volume expansion and increased cardiac output. Arterial blood pressure also increases with increasing obesity. In addition, type 2 diabetes mellitus may directly elicit abnormalities in myocardial metabolism and function through intramyocardial triglyceride deposition and lipotoxicity. In a study from our group, obese women with insulin resistance showed increased myocardial lipid accumulation compared with obese insulin-sensitive women, and intramyocardial lipids were reduced by dietary weight loss. Finally, intramyocardial lipids are associated with impaired diastolic function in patients with type 2 diabetes mellitus. Myocardial insulin resistance may also contribute to heart failure, because genetic deletion of cardiac insulin receptors in mice worsens catecholamine-mediated myocardial injury. Heart failure risk may be further exacerbated through obesity-induced neurohumoral activation and systemic inflammation. Inflammatory cytokines are elevated in heart failure and modulate cardiac remodelling through various mechanisms including myocardial hypertrophy, fibrosis, and apoptosis.
Sodium-glucose cotransporter 2 (SGLT2) inhibitors are a new drug class for the treatment of type 2 diabetes mellitus. SGLT2 inhibitors may be particularly suitable in improving cardiac structure and function because they substantially improve systemic glucose metabolism, lower blood pressure, and reduce body weight. These effects reduce sympathetic vasomotor tone, and renin-angiotensin-system activity. Thus, SGLT2 inhibitors including empagliflozin ameliorate metabolic and hemodynamic risk factors tightly linked with left ventricular hypertrophy and heart failure risk. Recently published outcome data suggest a beneficial effect of empagliflozin on heart failure hospitalisation rates and on overall cardiovascular mortality in patients with type 2 diabetes and previously diagnosed cardiovascular disease.
Study Rationale Patients with type 2 diabetes mellitus are exposed to an excessive heart failure risk secondary to left ventricular hypertrophy and impaired diastolic filling, a condition not addressed by currently available treatments. The abnormality results from obesity-induced volume overload, increased blood pressure, and myocardial fat accumulation. By improving metabolism, body weight, and blood pressure, empagliflozin addresses the root causes of myocardial disease associated with type 2 diabetes-. We will assess left ventricular mass, function, and lipid content in patients with type 2 diabetes mellitus before and after 24 weeks treatment with metformin plus empagliflozin or glimepiride. We expect to observe improvements in left ventricular mass, function, and fat content with empagliflozin. The results of the study will help to understand the mechanisms of cardioprotective effects of empagliflozin that have been revealed recently.
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: Empagliflozin25 mg/d empagliflozin + matching glimepiride placebo for 24 weeks. |
| Glimepiride | Active comparator | Drug: Glimepiride2 or 4 mg/d glimepiride+ matching empagliflozin placebo for 24 weeks. |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- women and men ≥40 and <80 years of age
- patients with type 2 diabetes mellitus on stable anti-diabetic treatment for the last 3 months; at screening the following treatment conditions are allowed:
- waist circumference ≥80 cm in women or ≥94 cm in men
- office blood pressure ≤150/95 mm Hg with a stable dose of a maximum of 4 antihypertensive medications for the last 3 months (24h ambulatory blood pressure measurement (ABPM) is allowed to check accuracy of office values; inclusion with 24h mean blood pressure ≤145/90 mm Hg is possible)
- women without childbearing potential defined by:
Key exclusion criteria (32 listed)
- diabetes mellitus type 1
- uncontrolled diabetes mellitus type 2 with fasting glucose > 13.3 mmol/l confirmed on a second day
- previous treatment with insulin, glucagon-like peptide-1 analogues, or pioglitazone during the last year before screening
- previous treatment with empagliflozin
- acute illness at screening or randomization according to judgement by the investigator or patient
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: JardianceTreatment with empagliflozin vs. glimepiride to understand whether empagliflozin may reduce left ventricular mass in patients with type 2 Diabetes mellitus. | Drug | Empagliflozin |
| GlimepirideAlso: AmarylTreatment with empagliflozin vs. glimepiride to understand whether empagliflozin may reduce left ventricular mass in patients with type 2 Diabetes mellitus. | Drug | Glimepiride |
Primary outcome
change in left ventricular mass
Time frame: baseline and 24 weeks
change in left ventricular mass determined by cardiac MRI as the difference between 24 weeks and baseline
12 secondary outcomes
change in left ventricular end-systolic volume
Time frame: baseline and 24 weeks
change in left ventricular function
Time frame: baseline and 24 weeks
change in intramyocardial lipid content
Time frame: baseline and 24 weeks
change in diastolic function
Time frame: baseline and 24 weeks
change in HbA1c
Time frame: baseline and 24 weeks
change in fasting plasma glucose concentration
Time frame: baseline and 24 weeks
change in body weight
Time frame: baseline and 24 weeks
change ambulatory blood pressure
Time frame: baseline and 24 weeks
change in left ventricular end-diastolic volume
Time frame: baseline and 24 weeks
change in fasting serum insulin concentration
Time frame: baseline and 24 weeks
change in waist circumference
Time frame: baseline and 24 weeks
change in body fat mass
Time frame: baseline and 24 weeks
Results and safety
The study was stopped early (reason given: Insufficient recruitment.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Jens Jordan, Prof. Dr. principal investigator
Hannover Medical School
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 Glimepiride in people with Diabetes Mellitus Type 2, run by Hannover Medical School 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 19 inclusion and 32 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: stopped early, as of the sponsor's last update on 22 Mar 2019. 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 was stopped early (reason given: Insufficient recruitment.). Results are not available in the source record.
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?
change in left ventricular mass (time frame: baseline and 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Mar 2019.