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

Phase 1

Completed

• Conditions: Type 2 Diabetes mellitus; Chronic Kidney Disease; Metabolic and Endocrine - Diabetes; Renal and Urogenital - Kidney disease

• Registration Number: ACTRN12616001248459
• Lead Sponsor: Dr Ajith Dissanayake

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-09-07
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 18

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Trough metformin serum concentrations using high performance liquid chromatography (HPLC)[Weekly levels for 4 weeks]

Secondary Outcome Measures

Name	Time	Method
Single dose pharmacokinetic profile for metformin in patients with stage 4 chronic kidney disease using HPLC assay to measure serum metformin concentrations at 0, 2, 4, 6 ,8 and 24 hours.[Day 4 at 0, 2, 4, 6 ,8 and 24 hours.];72 hour continuous capillary glucose monitoring using an implanted Continuous Glucose Control Monitoring System (CGMS) with the sensor inserted subcutaneously into the abdominal wall.[Day 1-3 and Day 29-31];Hemoglobin A1c serum assay[Day 1 and Day 32];Serum lactate levels[Day 1, 11, 18, 25, 32];Serum bicarbonate levels[Day 1, 11, 18, 25, 32];Venous pH via venous blood gas[Day 1, 11, 18, 25, 32]