Empagliflozin effect on glucose toxicity in type 2 diabetes patients - a randomized, open-label, controlled, parallel group, exploratory study

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 50

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

•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 < 60 ml/min/1.73 m2
•Marcoalbuminuria defined as albumin > 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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials