Patients with T2DM aged 40 to 70 years (including)
Conditions
Sponsors
University Hospital Tuebingen
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female patients aged between 40 and 70 years (including) at the first screening visit • T2DM patients with HbA1c between 7-9% (including), receiving metformin and/or DPP IV-inhibitor • Accepted background medication: Metformin and/or DPP-IV inhibitors • Stable treatment with antidiabetic drugs over the last 4 weeks • Body mass index (BMI) between 25 kg/m2 and 40 kg/m2 (including) • Ability to understand and follow study-related instructions 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 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 25
Exclusion criteria
Exclusion criteria: • Unstable Angina pectoris, myocardial infarction or stroke within 1 year before inclusion in the study • History of atrial fibrillation • Uncontrolled arterial hypertension (> 160/100 mmHg in three subsequent measurements – mean value) • eGFR 200 mg/l in spontaneous urine • Triglyceride > 250mg/dl • Genetic muscle disease • Known coagulation disorder • Treatment with anti-platelet therapy and anticoagulation which cannot be paused for medical reasons • Treatment with anticoagulants within 7 days prior to the muscle biopsy • Occurrence of ketoacidosis with the requirement for emergency care • Contraindications according to the local SmPC of Lantus® or Jardiance® (see Appendix 1) • History of hypersensitivity to any of the study drugs or their ingredients or to drugs with similar structure or to the local anesthetic scandicaine or lidocaine • Addiction or other diseases that preclude the patient from appropriately assessing the nature and scope as well as possible consequences of the clinical study • Pregnant or breast-feeding women • Women of childbearing potential unless women who meet the following criteria: • Post-menopausal (12 months natural amenorrhea or 6 months amenorrhea with serum FSH > 40 U/mL) • Postoperatively (six weeks after bilateral ovariectomy with or without hysterectomy) • Regular and correct use of a contraceptive method with error rate < 1% per year such as implants, depot injections, oral contraceptives or intrauterine devices • Sexual abstinence • Vasectomy of the partner Males must agree not to father a child and to refrain from donating semen or sperm while participating in the study and for 90 days following discontinuation from this study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to investigate the change in H2O2 concentration as a read out of reactive oxygen species (ROS) production in skeletal muscle biopsies from T2DM patients before and after treatment with empagliflozin or insulin glargine.;Secondary Objective: •to evaluate the change in skeletal muscle respiration rates (O2 consumption) as a read-out for skeletal muscle mitochondrial function •to measure the change in skeletal muscle lipid peroxidation as a functional consequence of increased ROS production •to analyze the 24-hour urinary excretion rate of 8-iso prostaglandin F2a (PGF2a) as a marker for oxidative stress •to evaluate the difference in genome wide DNA methylation pattern at single-nucleotide resolution in skeletal muscle •to evaluate contribution of circulating free fatty acid (FFA) levels to skeletal muscle ROS production ;Primary end point(s): •Change in skeletal muscle H2O2 concentration between baseline and end of treatment;Timepoint(s) of evaluation of this end point: at baseline and end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Change in skeletal muscle mitochondrial function (O2 consumption) between baseline and EoT • Change in skeletal muscle lipid peroxidation between baseline and EoT • Change in 24-hour urinary excretion rate of 8-iso PGF2a between baseline and EoT • Changes in DNA methylation pattern in skeletal muscle between baseline and EoT as well as difference in DNA methylation pattern in skeletal muscle between the treatment groups at EoT • Change in plasma FFA levels between baseline and EoT ;Timepoint(s) of evaluation of this end point: at baseline and end of treatment | — |
Countries
Germany
Contacts
Public ContactClinic for Diabetology, Endocrinolo
University Hospital Tuebingen
Outcome results
None listed