None listed
Conditions
Brief summary
Type 2 diabetes is a leading cause of end-stage kidney disease (ESKD). The risk of cardiovascular complications is high in diabetic dialysed patients. Metformin has been shown to reduce these complications. However, it is not used in these patients due to the risk (very low) of acidosis. To address this urgent health problem, we aim to investigate the safety of low dose metformin in these patients. This study will consist of 3 arms, the pharmacokinetics arm, the extended pharmacokinetics arm and the safety arm. In the first arm patients (n=5) will receive 500 mg of metformin after dialysis for 12 weeks. In the second (n=10) and thrid arm (n=50) patients will receive 250 mg of metformin after dialysis (3 dialysis session per week) for 24 weeks. We hypothesis that low dose metformin can be safely given to dialysis patients.
Interventions
Arm 1 (Pharmacokinetic sub-study): Patients on haemodialysis (n=5) will receive 500 mg of metformin hydrochloride (oral tablet, immediate release formulation) after each dialysis session (3 dialysis sessions per week, 1500 mg/ week) for 12 weeks.
Arm 2 and 3 ( Extended Pharmacokinetic study and Safety study): Patients on haemodialysis (n=10, n=50) will receive 250 mg of metformin hydrochloride (oral tablet, immediate release formulation) after each dialysis session (3 dialysis sessions per week
Arm 1 (Pharmacokinetic sub-study): Patients on haemodialysis (n=5) will receive 500 mg of metformin hydrochloride (oral tablet, immediate release formulation) after each dialysis session (3 dialysis sessions per week, 1500 mg/ week) for 12 weeks. Arm 2 and 3 ( Extended Pharmacokinetic study and Safety study): Patients on haemodialysis (n=10, n=50) will receive 250 mg of metformin hydrochloride (oral tablet, immediate release formulation) after each dialysis session (3 dialysis sessions per week, 750 mg/ week) for 24 weeks. These two arms differ only in the timings of blood sampling for pharmacokinetic analysis at each study visit. Patients will take their doses within 30 minutes of dialysis ending along with their normal medication. Nursing staff take record of all the doses administered, this is be used to determine compliance.
Sponsors
St Vincent's Hospital Sydney
Study design
Allocation
Non-randomised trial
Intervention model
Other
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patients with type 2 diabetes mellitus and end-stage kidney disease. Patients currently undergoing either haemodialysis or peritoneal dialysis. Patients not currently taking metformin.
Exclusion criteria
Women lactating, pregnant or of childbearing potential who are not willing to avoid becoming pregnant during the study. Patients with a history of a psychological illness or condition such as to interfere with the patient's ability to understand the requirements of the study. Patients with a history of lactic acidosis.
Outcome results
None listed