Effect of an L-Carnitine-Containing Peritoneal Dialysis (PD) Solution on Insulin Sensitivity in Diabetic Patients on Continuous Ambulatory Peritoneal Dialysis (CAPD)

• Status: Withdrawn
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

Summary

The current study is initiated in order to assess the impact of a PD solution containing L-carnitine on insulin sensitivity evaluated by measuring insulin requirement.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Iperboreal Pharma Srl
• Treatments: Insulin; Pharmaceutical Solutions

Criteria

Inclusion Criteria:

1. Age ≥18 years

2. Have a diagnosis of ESRD and have been on Continuous Ambulatory Peritoneal Dialysis (CAPD) for at least 3 months

3. Have Type 2 Diabetes, diagnosed according to American Diabetes Association (fasting glucose ≥126 mg/dl and 2 h glucose at OGTT ≥200 mg/dl), and treated with multiple daily insulin injection or with HbA1c > 8.5% (No oral antidiabetic)

4. Be in a stable clinical condition during the four weeks immediately prior to Screening Period as demonstrated by medical history, physical examination and laboratory testing

5. Have a blood hemoglobin concentration above 8,5 g/100ml (data will be verified with Investigators)

6. Have not experienced peritonitis episodes in the last 3 months

7. Be treated with Extraneal (nocturnal exchange bag solution) for at least 1 month

8. Be treated with 3 diurnal exchange bag solutions (solution bags with 1.5% or 2.5% glucose) and one nocturnal exchange bag solution (Extraneal)

9. Have Kt/V urea measurement > 1.7 per week in a previous test performed within 3 months that should be confirmed at Baseline Visit

10. Have a minimum weekly creatinine clearance of 45 litres in a previous test performed within 6 months that should be confirmed at Baseline Visit

11. Have a D/P Creatinine ratio at Peritoneal Equilibration Test (PET) between 0.50 and 0.81 in a previous test performed within 6 months that should be confirmed at Baseline Visit

12. Have a D/P Glucose ratio at Peritoneal Equilibration Test (PET) between 0.26 and 0.49 in a previous test performed within 6 months that should be confirmed at Baseline Visit

13. Be treated by the participating clinical Investigator for a period of at least three months

14. Have understood and signed the Informed Consent Form.

Exclusion Criteria:

1. Have a history of drug or alcohol abuse in the six months prior to entering the protocol

2. Type 2 Diabetic patients under oral antidiabetic treatment with HbA1C < 8.5%

3. Be in treatment with androgens

4. Have clinically significant abnormal liver function test (SGOT, SGPT, and gamma-GT > 2 times the upper normal limit)

5. Have acute infectious conditions (i.e.: pulmonary infection, acute hepatitis, high or low urinary tract infections, renal parenchymal infection, pericarditis, etc)

6. Have a history of congestive heart failure and clinically significant arrhythmia

7. Have an history of epilepsy or any CNS disease

8. Have malignancy within the past 5 years, including lymphoproliferative disorders

9. Have any medical condition that, in the judgment of the Investigator, would jeopardize the patient's safety following exposure to study drug

10. Have a history of L-Carnitine therapy or use in the month prior to entering the protocol

11. Have used any investigational drug in the 3 months prior to entering the protocol

12. Be in pregnancy, lactation, fertility age without protection against pregnancy by adequate contraceptive means