drugset / Trial / NCT05219942
Outcome of Glargine Insulin in Renal Impairment Patients With Diabetic Ketoacidosis
RandomizedParallel-groupTriple-blindTreatment
Summary
The study aims to compare between the use of continuous low dose insulin infusion versus co-administration of low dose continuous insulin infusion and early subcutaneous insulin glargine in diabetic ketoacidosis patients with chronic renal impairment. aim to investigate the effect of using the long acting insulin analogue glargine on the resolution time of diabetic ketoacidosis in renal impairment patients who have altered insulin pharmacokinetics and pharmacodynamics and the rate of adverse effects of this approach
Timeline
- Start
- 2020-12-01
- Primary completion
- 2022-06
- Completion
- 2022-07
Publications
- Background Barski L, Kezerle L, Zeller L, Zektser M, Jotkowitz A. New approaches to the use of insulin in patients with diabetic ketoacidosis. Eur J Intern Med. 2013 Apr;24(3):213-6. doi: 10.1016/j.ejim.2013.01.014. Epub 2013 Feb 8.
- Background Barski L, Brandstaetter E, Sagy I, Jotkowitz A. Basal insulin for the management of diabetic ketoacidosis. Eur J Intern Med. 2018 Jan;47:14-16. doi: 10.1016/j.ejim.2017.08.025. Epub 2017 Aug 31.
- Background Chapter 1: Definition and classification of CKD. Kidney Int Suppl (2011). 2013 Jan;3(1):19-62. doi: 10.1038/kisup.2012.64. No abstract available.
- Background Savage MW, Dhatariya KK, Kilvert A, Rayman G, Rees JA, Courtney CH, Hilton L, Dyer PH, Hamersley MS; Joint British Diabetes Societies. Joint British Diabetes Societies guideline for the management of diabetic ketoacidosis. Diabet Med. 2011 May;28(5):508-15. doi: 10.1111/j.1464-5491.2011.03246.x.
- Background Svensson M, Yu ZW, Eriksson JW. A small reduction in glomerular filtration is accompanied by insulin resistance in type I diabetes patients with diabetic nephrophathy. Eur J Clin Invest. 2002 Feb;32(2):100-9. doi: 10.1046/j.1365-2362.2002.00949.x.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | insulin glargine | Protein / enzyme biologic | 0.19 iu/kg | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | 0.25 iu/kg | Subcutaneous |
| Comparator | insulin glargine | Protein / enzyme biologic | 0.27 iu/kg | Subcutaneous |