Poorly controlled type 2 diabetes mellitus in adults
Conditions
Interventions
Trade Name: Jardiance® 10mg Filmtabletten
Product Name: Jardiance® 10mg Filmtabletten
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: Empagliflozin
CAS Number: 864070-44-0
Other descripti
Sponsors
University Medical Center of the Johannes Gutenberg-University Mainz
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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: - Left ventricular diastolic function after 1 week - Left ventricular systolic function - Left end-diastolic volume (LEDV) - Arterial stiffness - Vascular dysfunction - Humoral biomarker ;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
| Measure | Time frame |
|---|---|
| Secondary end point(s): - E/E’ ratio (change from baseline (V1) to 1 week follow-up (2D-echocardiography) - E/E’ ratio (change from baseline (V1) to 12 week follow-up (2D-echocardiography) in the subgroup of patients with eGFR 45-59 ml/min/1.73 m² - E/E’ ratio (change from baseline (V1) to 12 week follow-up (2D-echocardiography) in the subgroup of patients with HbA1c 6.5% - 6.9% - Left ventricular systolic function (LVEF) - Left end-diastolic volume (LEDV) - Ankle brachial index from baseline to 12 weeks follow-up - Carotid-femoral pulse wave velocity (cf-PWV, vascular explorer - calculated) - Augmentation index (AIx, vascular explorer) - Arterial stiffness index (SI, photo plethysmography) - Reflection index (photo plethysmography) - Brain natriuretic peptide (BNP) - High sensitive troponin I (hs TnI) - High sensitive C-reactive protein (hs CRP) ;Timepoint(s) of evaluation of this end point: Secondary endpoints include assessment of the effects of empagliflozin treatment on the changes from baseline (day 1) to the follow-up visits after 1 week and 12 weeks (?) for the Parameters listed under E.5.2. | — |
Countries
Germany
Contacts
Public ContactPhilipp Wild
University Medical Center of the Johannes Gutenberg-University Mainz
Outcome results
None listed