The use of metformin in patients with moderate to severe renal failure and type 2 diabetes

A pharmacokinetic study of metformin in patients with stable stage 4 chronic kidney disease and type 2 diabetes

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12616001248459

Enrollment

Registered

2016-09-07

Start date

2012-05-07

Completion date

2014-03-03

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

The primary goal of this study was to establish if treatment with low dose metformin in patients with stage 4 chronic kidney disease would produce safe and therapeutic serum levels of metformin. Metformin is widely acknowledged to be the first choice treatment for type 2 diabetes mellitus but fears around accumulation in patients with kidney disease have limited it's use in this patient group. Our aim is to investigate the use of low dose metformin in this group by showing predictable, stable and safe drug levels with low dose treatment.

Interventions

Intervention: Low dose metformin of 250mg, 500mg and 1000mg per day. Patients in cohort 1 will take 250mg dose. When this cohort has completed treatment cohort 2 will commence. Patients in cohort 2 will take a 500mg dose. After completion of cohort 2, patients in cohort 3 will commence and take the 1000mg dose. Duration: 4 weeks Method of administration: Oral Adherence monitoring: Pill count and drug plasma level monitoring

Study design

Allocation

Non-randomised trial

Primary purpose

Treatment

Eligibility

Sex/Gender

All

Age

30 Years to 75 Years

Healthy volunteers

Inclusion criteria

1. Type 2 diabetes for at least 2 years 2. Haemoglobin A1c between 6 and 11% 3. Stable stage 4 chronic kidney disease as defined by estimated glomerular filtration rate of 15-29mls/1.73m2.

Exclusion criteria

1. Current treatment with metformin 2. Previous intolerance to metformin 3. Body mass greater than 160kg 4. Severe COPD as evidenced by hospitalization for decompensation within 6 months of randomization, chronic treatment with oral steroids 5. Unstable CHF needing frequent hospitalisations or frequent adjustment of heart failure medications 6. Significant IHD with acute coronary event, and/or CABG, and/or PCI in the previous 60 days. 7. Severe liver disease with icterus and plasma bilirubin greater than or equal to 60 micrommol/L, plasma transaminase greater than 3-fold upper limit of normal, albumin less than 25 g/L or coagulopathy. 8. Haemoglobin less tha 100 g/L or platelet count less than 80,000/mm3 9. Gastrointestinal bleeding in the previous 60 days 10. Unstable angina or planned for invasive cardiac investigations in the next 6 months 11. Malignancy other than basal cell carcinoma. 12. Any other disease or condition which in the opinion of the investigator could make them unsuitable for entry. 13. Pregnant, nursing a child, or planning a pregnancy at the time of this study

Outcome results