Status:
WITHDRAWN
Empagliflozin Effect on Glucose Toxicity
Lead Sponsor:
University Hospital Tuebingen
Conditions:
Type2 Diabetes Mellitus
Eligibility:
All Genders
40-70 years
Phase:
PHASE4
Brief Summary
Empagliflozin effect on glucose toxicity in type 2 diabetes patients - a randomized, open-label, controlled, parallel group, exploratory study
Detailed Description
The EMPA-REG outcome trial showed that empagliflozin on top of standard therapy for Type 2 diabetes mellitus (T2DM) resulted in superiority in terms of the primary composite cardiovascular endpoint (h...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 3 2023
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03437330
Start Date
October 27 2021
End Date
May 3 2023
Last Update
May 16 2024
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
University Hospital
Tübingen, Baden-Wurttemberg, Germany, 72076
2
German Diabetes Center, Leibniz-Center for Diabetes Research at the Heinrich-Heine-University Duesseldorf
Düsseldorf, North Rhine-Westphalia, Germany, 40225