Effects of empagliflozin on heart function compared to usual care in individuals with type 2 diabetes
- Conditions
- Poorly controlled type 2 diabetes mellitus in adultsTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
- Registration Number
- EUCTR2016-001264-11-DE
- Lead Sponsor
- niversity Medical Center of the Johannes Gutenberg-University Mainz
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 158
Subjects meeting all of the following criteria at visit 0 (screening) will be considered for enrollment 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% 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 with E/E’ ratio = 8 (2D-echocardiography)
- Age 18 – 84 years
- BMI = 45 kg/m² (Body Mass Index) (at visit 0 and/or visit 1)
- 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 according to the recommendations of the Clinical Trial Facilitation Group (1). 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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 39
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 119
Subjects presenting at least one of the following criteria at visit 0 (screening) will not be enrolled 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 ALT (SGPT), AST (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 with 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
- 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)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of the trial is to investigate if 12 weeks oral empagliflozin treatment in addition to standard diabetes therapy or dietetic treatment improves the cardiac diastolic function in individuals with type 2 diabetes mellitus.;Secondary Objective: The secondary objectives of the trial include assessment of the effects of empagliflozin treatment on the change from baseline to the follow-up visits after 1 week and 12 weeks (?) for the following parameters:<br>- Left ventricular diastolic function after 1 week<br>- Left ventricular systolic function<br>- Left end-diastolic volume (LEDV)<br>- Arterial stiffness<br>- Vascular dysfunction <br>- Humoral biomarker<br>;Primary end point(s): The primary endpoint of this trial is the 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.;Timepoint(s) of evaluation of this end point: - after 12 weeks
- Secondary Outcome Measures
Name Time Method