Post-Transplant Diabetes Mellitus
Conditions
Interventions
Trade Name: Jardiance
Product Name: Empagliflozin
Pharmaceutical Form: Tablet
INN or Proposed INN: empagliflozin
CAS Number: 864070-44-0
Other descriptive name: EMPAGLIFLOZIN
Concentration unit: mg mi
Sponsors
Medical University of Vienna
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Diagnosed PTDM defined as: 2 hour plasma glucose level = 200 mg/dL in the OGTT (75mg glucose), twice blood glucose levels = 200 mg/dL during random controls or twice fasting glucose levels = 125 mg/dL or HbA1c = 6.5% Stable graft function for more than 6 months post transplantation (eGFR = 30 ml/min) At least 6 months of basal insulin therapy for PTDM 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 10 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6
Exclusion criteria
Exclusion criteria: Age 40 IE/day or HbA1c >8.5%.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether monotherapy with empagliflozin has the same efficacy in controlling hyperglycaemia as standard basal insulin therapy (not succeeding 40 IE/day) in kidney transplanted patients with PTDM, as judged by 2-hour glucose levels during an oral glucose tolerance test (OGTT). ;Secondary Objective: To assess differences in the change of HbA1c after 3 months of empagliflozin monotherapy compared to baseline HbA1c. To assess the efficacy of empagliflozin, judged by differences in glycaemic control (glucose profiles and urinary glucose) after 1 month of empagliflozin monotherapy compared to baseline glycaemic control. To assess differences in metabolic parameters (insulin secretion and insulin sensitivity after 1 month of empagliflozin monotherapy compared to baseline insulin secretion and sensitivity). To assess the safety of empagliflozin in kidney transplanted patients, and specifically whether monotherapy with empagliflozin can be upheld for at least 1 year without clinically intolerable side effects (ketoacidosis, urinary tract infections, genital infections, decline of renal function, rate of bone fractures) according to best clinical care standard.;Primary end point(s): 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 > 20 mg/dL on average (>100 mg/dL in each individual).;Timepoint(s) of evaluation of this end point: 1 month after start of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Mean change from baseline insulin secretory capacity and insulin sensitivity after 1 month of empagliflozin monotherapy (derived by OGTT). Mean change from baseline HbA1c serum levels after 3 month of empagliflozin monotherapy. Mean change from baseline body weight after 1 month of empagliflozin monotherapy. Mean change from baseline blood pressure after 1 month of empagliflozin monotherapy. No clinically intolerable ketoacidosis or ketonuria after 1 month of empagliflozin monotherapy. No clinically intolerable urinary tract infections (UTI) after 1 month of empagliflozin monotherapy. No decline of renal function defined by eGFR of 50 mg/dL on average (>100 mg/dL in each individual), patients will receive add-on insulin therapy. Mean change from baseline insulin secretory capacity and insulin sensitivity during the entire study period of 1 year of empagliflozin monotherapy. (OGTT). Mean change from baseline HbA1c serum levels from baseline during the entire study period of 1 year of empagliflozin monotherapy. Mean change from baseline body weight from baseline during the entire study period of 1 year of empagliflozin monotherapy. Mean change from baseline blood pressure from baseline during the entire study period of 1 year of empagliflozin monotherapy. No clinically intolerable ketoacidosis (determined by venous blood gas analysis) or ketonuria (determined by blood and urinary analysis) during the entire study period of at least 1 year of empagliflozin monotherapy. No clinically intolerable of urinary tract infections (UTI) or genital infections during the entire study period of 1 year of empagliflozin monotherapy. No decline of renal function defined by eGFR of >25% during the entire study period of 1 year of empagliflozin monotherapy.;Timepoint(s) of evaluation of this end point: 1 month and 1 year after start of treatment | — |
Countries
Austria
Contacts
Public ContactClinical Trials Information
Medical University of Vienna
Outcome results
None listed