Empagliflozin Effect on Glucose Toxicity

• Status: Not yet recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: GWT-TUD GmbH; University Hospital Tuebingen
• Treatments: Empagliflozin; Insulin; Insulin Glargine; Insulin, Globin Zinc

Criteria

Inclusion Criteria:

Subjects must fulfill all of the following criteria before inclusion in the study:

• The informed consent form must be signed before any study specific tests or procedures are done

• Male or female patients aged between 40 and 70 years (including) at the first screening visit

• Patients diagnosed with T2DM

• HbA1c between 7-9% (including)

• Stable treatment with antidiabetic drugs over the last 4 weeks

• Accepted background medication:

• Metformin up to 2000 mg per day and/or

• DPP-IV inhibitors:

Linagliptin up to 5 mg per day Sitagliptin up to 100 mg per day Vildagliptin up to 100 mg per day Saxagliptin up to 5 mg per day

• Body mass index (BMI) between 25 and 40 kg/m2 (including)

• Ability to understand and follow study-related instructions

• No clinical relevant abnormalities during ECG and cardiac examinations

Exclusion Criteria:

Subjects are to be excluded from the study if they display any of the following 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

• Macroalbuminuria defined as ≥ 300 mg albumin / 24h urine

• Triglyceride > 250 mg/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

• 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 follicle-stimulating hormone [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