RENAL TRANSPLANT SUBJECTS WITH OR WITHOUT TYPE 2 DIABETES AND TYPE 2 DIABETIC SUBJECTS WITH NORMAL RENAL FUNCTION MedDRA version: 21.0 Level: PT Classification code 10038533 Term: Renal transplant System Organ Class: 10042613 - Surgical and medical procedures MedDRA version: 21.1 Level: PT Classification code 10067585 Term: Type 2 diabetes mellitus System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Sponsors
AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Inclusion Criteria 1. Males and females 2. Age = 30-65 years 3. BMI= 25-35 Kg/m2 and stable weight (± 3 lbs) over the preceding three months 4. Normal Glucose Tolerance or Type 2 diabetes 5. Renal transplant at least 3 months on a stable dose of any combination of the following immunosuppressant medications: - Mycofenolate Mofetil or Sodium - Tacrolimus or Tacrolimus Prolonged Released - Everolimus - Sirolimus - Prednisone (60 ml/min/1.73 m2) after transplantation 8. Drug naive for T2DM treatment or metformin and/or sulfonylurea on stable dose more than 3 months 9. Subjects are capable of giving informed consent Inclusion Criteria (Control Group) 1. Males and females 2. Age = 30-65 years 3. BMI= 25-35 Kg/m2 and stable weight (± 3 lbs) over the preceding three months 4. Type 2 diabetes 5. Stable GFR (>60 ml/min/1.73 m2) 6. HbA1c > 6.5 % and =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Exclusion Criteria (for both groups) 1. Prednisone treatment at a dose = 7.5 mg per day or Metilprednisolone at a dose = 6 mg per day 2. Beta blocker or any medication that affects sympathetic/parasympathetic activity 3. 3. Drugs known to affect glucose metabolism (other than metformin and sulfonylurea and those listed in the inclusion criteria) 4. Known Dapagliflozin Excipient Hypersensitivity 5. Liver function enzymes higher more than two times the upper limit 6. Heart Failure (NYHA III-IV) 7. Ongoing urinary tract infection 8. Blood pressure >140/90 mmHg 9. Loop diuretics or thiazide diuretics therapy 10. Hematocrit > 52% 11. Type 1 Diabetes 12. Diabetic Ketoacidosis 13. GFR 300 mg 16. Donation of blood to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of > 400 mL of blood during the 8 weeks prior to the enrollment visit 17. Women of child bearing potential who are unwilling or unable to use an acceptable method to avoid pregnancy for the entire study 18. Women who are pregnant or breastfeeding 19. Patient with a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient or interfere with trial procedures
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test the hypothesis that a single dapagliflozin (10 mg) oral administration in subjects with or without type 2 diabetes and renal transplant will stimulate EGP and increase plasma glucagon concentration as compared to placebo. The same hypothesis will be tested in patients with T2DM and normal renal function, and then the differences (Dapagliflozin vs. placebo) will be compared between the two groups.;Secondary Objective: To test the hypothesis that a single dapagliflozin (10 mg) oral administration in subjects with or without type 2 diabetes and renal transplant will modulate plasma glucose, insulin, c-peptide, FFA and blood pressure as compared to placebo. The same hypothesis will be tested in patients with T2DM and normal renal function, and then the differences (Dapagliflozin vs. placebo) will be compared between the two groups.;Primary end point(s): The primary endpoint is the mean difference in EGP during the last hour of EGP measurement between dapagliflozin versus placebo administration in patients with or without T2DM and renal transplant versus subjects with T2DM and without renal transplant. ;Timepoint(s) of evaluation of this end point: This timepoint will be achieved in a three years study | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary endpoints are the mean difference in plasma glucose, insulin, c-peptide, FFA and blood pressure during the last hours of the experiment between dapagliflozin versus placebo administration in patients with or without T2DM and renal transplant versus subjects with T2DM and without renal transplant;Timepoint(s) of evaluation of this end point: This timepoint will be achieved in a three years study | — |
Countries
Italy
Contacts
Public ContactU.O. MALATTIE METABOLICHE E DIABETO
U.O. MALATTIE METABOLICHE E DIABETOLOGIA
Outcome results
None listed