Empagliflozin in Post-Transplantation Diabetes Mellitus (EMPTRA-DM)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT03113110 |
Recruitment Status :
Completed
First Posted : April 13, 2017
Last Update Posted : May 7, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
RELEVANCE:
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 |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Empagliflozin in Post-Transplantation Diabetes Mellitus |
Actual Study Start Date : | January 15, 2017 |
Actual Primary Completion Date : | June 13, 2017 |
Actual Study Completion Date : | May 31, 2018 |

Arm | Intervention/treatment |
---|---|
Empagliflozin Arm
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).

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Diagnosed PTDM defined as: A transplant patient requiring antidiabetic therapy, based on a previous 2-hour plasma glucose level ≥ 200 mg/dL in the OGTT (75mg glucose), based on previous blood glucose levels ≥ 200 mg/dL during random controls or based on fasting glucose levels ≥ 125 mg/dL twice or HbA1c ≥ 6.5%
- Stable graft function for more than 6 months post transplantation (eGFR ≥ 30 ml/min/1.73m2)
- At least 6 months of standard of care antidiabetic therapy (usually basal insulin) for PTDM
Exclusion Criteria:
- Age< 18 years
- Patients with prior history of type 1 or type 2 diabetes
- Pregnancy
- Severe renal impairment (GFR < 30 mL/min./1.73 m2)
- Severe blood glucose elevation with the need for therapy with insulin > 40 IU/day or HbA1c >8.5%

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
Austria | |
Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria | |
Vienna, Austria, 1090 |
Principal Investigator: | Manfred Hecking, MD | Department of Internal Medicine III, Division of Nephrology and Dialysis, Medical University of Vienna, Austria |
Responsible Party: | Assoc. Prof. Dr. Manfred Hecking, MD PhD, Assoc. Prof. PD. Dr.med., Medical University of Vienna |
ClinicalTrials.gov Identifier: | NCT03113110 |
Other Study ID Numbers: |
EUDRACT-Nr: 2016-001580-37 EK-No. 1366/2016 ( Other Identifier: MUVienna Ethics Committee ) |
First Posted: | April 13, 2017 Key Record Dates |
Last Update Posted: | May 7, 2019 |
Last Verified: | May 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Empagliflozin SGLT-2 Inhibition Glucose Metabolism |
Diabetes Mellitus Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases Empagliflozin |
Sodium-Glucose Transporter 2 Inhibitors Molecular Mechanisms of Pharmacological Action Hypoglycemic Agents Physiological Effects of Drugs |