The effect of metformin in diabetic patients with kidney disease

Evaluating the safety and efficacy of metformin in patients with type 2 diabetes and chronic renal impairment

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611000893909

Enrollment

Registered

2011-08-22

Start date

2010-02-01

Completion date

Unknown

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This is an open-label, fixed regimen clinical study. Enrolled patients were administered low dose metformin (250mg or 500mg) to examine the effect and exposure of metformin in patients with chronic renal impairment. Patients were monitored frequently to ensure metformin concentrations and lactic acid concentrations were not high. The aim of this study is to determine whether metformin can be safely administered to patients with renal impairment.

Interventions

Patients with chronic renal impairment were administered low dose metformin, 500mg oral capsule daily for 6 weeks. Patients on dialysis were administered metformin at lower doses of 250mg daily for 6 weeks. At least 8 clinic visits were required for routine clinical care, including pathology tests.

Study design

Allocation

Non-randomised trial

Intervention model

Single group

Primary purpose

Treatment

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 100 Years

Healthy volunteers

Inclusion criteria

Kidney disease, type 2 diabetes

Exclusion criteria

Significant cardiac disease, any hypoxic condition, alcohol abuse, history of lactic acidosis.

Outcome results