Patients with type 2 diabetes mellitus on background metformin treatment. MedDRA version: 18.0 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
Hannover Medical School
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. women and men = 40 and 1 year • 1 year with serum FSH > 40 IU/l and serum estrogen=65 years) yes F.1.3.1 Number of subjects for this age range 15
Exclusion criteria
Exclusion criteria: 1. diabetes mellitus type 1 2. uncontrolled diabetes mellitus type 2 with fasting glucose > 13.3 mmol/l confirmed on a second day 3. previous treatment with insulin, GLP-1 analogues, or pioglitazone during the last year before screening 4. previous participation in another empagliflozin trial 5. acute illness at screening or randomization according to judgement by the investigator or patient 6. known or suspected hypersensitivity to empagliflozin, glimepiride or any excipients; known or suspected hypersensitivity to sulfonylureas or sulfonamides 7. history of multiple severe hypoglycemic episodes 8. any condition prohibiting MRI studies (e.g. metal implants, claustrophobia, body weight too high) 9. patient akctively attempted to lose weight or experienced unintentional clinically significant weight loss during the last 3 months 10. bariatric surgery or other gastrointestinal surgery procedures that induce chronic malabsorption 11. treatment with any weight loss drug in the preceding 6 months 12. planned significant changes of pre-study physical activity level during study participation 13. heart failure NYHA III – IV 14. patients with known severe cardiovascular disease (e.g. myocardial infarction, unstable angina, stable coronary artery disease, stroke or transient ischemic attack) 15. eGFR 48 % (women) and > 53 % (men) 18. chronic lower urinary tract infections 19. known acute or chronic liver disease or screening ALT or AST > 3 x ULN 20. serum potassium 5.0 mmol/l 21. glucose-6-phosphate dehydrogenase deficiency 22. anemia of unknown origin 23. pregnancy or lactation period 24. treatment with systemic glucocorticoids during the last 3 months before screening 25. chronic treatment with NSAIDs 26. changes in thyroid hormone dosage (stable doses of thyroid hormones for the last 3 months are acceptable) 27. history of drug or alcohol abuse or current abuse 28. psychosomatic or psychiatric diseases requiring hospitalization during the last 12 months; ongoing treatment with one tricyclic or SSRI antidepressant drug at a stable dose since the last 3 months is acceptable 29. medical history of cancer except for strictly localized tumors 30. any planned medical or surgical intervention planned for the next 7 months after randomization that does not allow study participation according to the investigator´s judgment 31. current participation in any other clinical trial or participation in another clinical trial within 30 days before screening
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • changes in cardiac dimensions, function, and metabolism • changes in glucose homeostasis • changes in body composition • changes in ambulatory blood pressure • changes in systemic and adipose tissue inflammatory markers and markers of insulin resistance ;Primary end point(s): Change in left ventricular mass determined by cardiac MRI as the difference between 24 weeks and baseline.;Timepoint(s) of evaluation of this end point: Week 24;Main Objective: To demonstrate that left ventricular mass is reduced with empagliflozin treatment compared to glimepiride treatment on top of stable metformin background medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • change in left ventricular end-systolic and end-diastolic volume (cMRI, 24 weeks – baseline) • changes in left ventricular function (cMRI, 24 weeks – baseline) • change in intramyocardial lipid content (cMR spectroscopy, 24 weeks – baseline) • change in diastolic function (echocardiography, 24 weeks – baseline) • change in HbA1c (24 weeks – baseline) • change in fasting glucose and insulin (24 weeks – baseline) • changes in body weight, waist circumference, and body fat mass (24 weeks – baseline) • change in ambulatory blood pressure (24 weeks – baseline) ;Timepoint(s) of evaluation of this end point: Week 24 | — |
Countries
Germany
Contacts
Public ContactInstitute of Clinical Pharmacology
Hannover Medical School
Outcome results
None listed