Empagliflozin in Post-Transplantation Diabetes Mellitus (EMPTRA-DM)
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|ClinicalTrials.gov Identifier: NCT03113110|
Recruitment Status : Recruiting
First Posted : April 13, 2017
Last Update Posted : April 13, 2017
Up to 50% of patients without previously known disorders of glucose metabolism develop posttransplantation diabetes mellitus (PTDM) after renal transplantation, which is associated with cardiovascular events. Although PTDM is triggered by immunosuppressive agents (calcineurin inhibitors, glucocorticoids), there is consensus against switching patients from potent tacrolimus to the less diabetogenic cyclosporin. Full-blown PTDM must therefore be treated aggressively. Empagliflozin inhibits sodium-glucose cotransporter 2 in the proximal tubule of the kidney and dramatically reduced cardiovascular risk in type 2 diabetics in a recent randomized trial. Especially in diabetics with impaired renal function, empagliflozin was safe, well tolerated, and effective against hyperglycemia and against high blood pressure. Data on SGLT2 inhibition after transplantation are completely lacking. Therefore, the potential antidiabetic of choice is currently withheld from the vulnerable PTDM population.
METHODS, STUDY DESIGN:
Prospective, single-center, non-inferiority study. Inclusion criteria: PTDM (antidiabetic therapy ≥6 months, based on prior 2-h BG ≥200 mg/dL, fasting BG ≥125 mg/dL (2 times) or HbA1c ≥6.5%); stable renal allograft function >6 months; eGFR ≥30 mL/min/1.73m2. Most important exclusion criteria: type 1 and 2 diabetes; insulin demand >40 IU/day; HbA1c >8.5%. After study inclusion, patients will record 4 weeks of 4-times daily BG measurements before undergoing an OGTT, lab work and urine analysis (including ketones, urinary culture). Empagliflozin (10 mg) will be started and insulin discontinued within 3 days. Patients will be asked to perform urinary dipstick tests at home (i.e. ketones), and to continue recording BG. Study visits at 2 and 4 weeks (second OGTT + lab work (as above)). If control over hyperglycemia is insufficient, insulin therapy will be added back, otherwise study patients remain on empagliflozin monotherapy for 1 year. Statistics will include the paired t-test.
|Condition or disease||Intervention/treatment||Phase|
|Posttransplant Diabetes Mellitus||Drug: Empagliflozin 10 mg||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||16 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Empagliflozin in Post-Transplantation Diabetes Mellitus|
|Actual Study Start Date :||January 15, 2017|
|Estimated Primary Completion Date :||December 31, 2019|
|Estimated Study Completion Date :||December 31, 2019|
Posttransplant Diabetes Mellitus (PTDM) patients after kidney transplantation receiving Empagliflozin 10 MG [Jardiance]
Drug: Empagliflozin 10 mg
PTDM patients on previous antidiabetic treatment (<40 IU insulin (in some cases plus oral antidiabetics)) receive Empagliflozin, ideally as monotherapy
Other Name: Jardiance
- OGTT-derived 2-hour blood glucose level [ Time Frame: 4 weeks after start of Empagliflozin treatment ]Mean change from baseline blood glucose levels of the 2h value after OGTT (75g glucose) after 1 month of empagliflozin monotherapy. Maximum tolerable change from baseline blood glucose levels should not exceed 30 mg/dL on average (100 mg/dL in each individual).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03113110
|Contact: Manfred Hecking, MDemail@example.com|
|Contact: Elisabeth Schwaiger, MDfirstname.lastname@example.org|
|Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria||Recruiting|
|Vienna, Austria, 1090|
|Contact: Manfred Hecking, MD email@example.com|
|Contact: Elisabeth Schwaiger, MD firstname.lastname@example.org|
|Principal Investigator:||Manfred Hecking, MD||Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria|