Investigation of whether metformin can be used safely and effectively in patients with type 2 diabetes on peritoneal dialysis

Phase 2

• Conditions: Type 2 Diabetes; Chronic kidney Disease- on peritoneal dialysis; Metabolic and Endocrine - Diabetes; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12612000864820
• Lead Sponsor: Tilenka Thynne

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-08-15
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

(1)>18 years old
(2)Type 2 DM
(3)Peritoneal Dialysis treatment of chronic kidney disease
(4)Patients in whom metformin would be used if they had normal renal function

Exclusion Criteria

(1)Any patient in whom metofrmin would not be used in the setting of normal renal function- moderate-severe heart failure, liver failure, alcohol abuse, major psychaitric disorder, acutely unwell or otherwise medically unstable.
(2)Unability or unwilling to measure own blood glucose concentrations via glucometer.
(3)Inability to provide written informed consent.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics of metformin in the setting of peritoneal dialysis[Metformin plasma concentrations matched with metformin peritoneal dialysis concentrations hourly 1-6 hours post first dose and post last dose at steady state (4 weeks later). In between trough metformin concentrations (plasma and peritoneal dialysis fluid and urine) weekly.];Safety of metformin in peritoneal dialysis[Baseline and weekly lactate, bicarbonate and pH concentrations.]

Secondary Outcome Measures

Name	Time	Method
To describe the pharmacodynamic effects of metformin in patients on peritoneal dialysis treated with metformin- evaluating insulin sensitivity pre and post treatment and blood glucose concentrations[Continous blood glucose monitor worn for 72 hours in the week prior and the final week of treatment.<br>Own blood glucose concentrations 3-4 times a day.<br>Fasting glucose and insulin for Homeostasis Model Assessment (HOMA2) of insulin sensitivity pre treatment and final week of treatment.]