drugset / Trial / NCT04690309

Human Versus Analogue Insulin in Patients After Pancreatectomy.

NCT04690309

Phase 4 Unknown 100 enrolled Polish Society of Diabetology
RandomizedParallel-groupOpen-labelTreatment

Summary

Pancreatectomy is a common treatment modality for both benign and malignant pathologies. One of the most common complications after pancreatectomy is pancreatogenous diabetes mellitus. Yet, insulin remains treatment of choice in patients after pancreatectomy, however there is little evidence on the choice of insulin preparation in patients with diabetes after pancreatectomy. In particular, it is unclear whether human or analogue insulin should be preferred in this group of patients.The aim of the study was to compare human vs analog insulin therapy in patients with diabetes prior to or diabetes developing after pancreatectomy performed due to pancreatic tumor. The study was designed as an open, prospective, randomized, intervention study.All patients provided written comprehensive informed consent. After surgery all patients who underwent total pancreatectomy were treated with insulin, while the patients who had partial pancreatectomy performed were treated with basal insulin when fasting plasma glucose exceeded 140 mg/dl and with prandial insulin when 2-hour postprandial plasma glucose exceeded 180 mg/dl.The patients who required insulin treatment after surgery were randomized with the use of random numbers generator (www.randomizer.org) into two groups: Group 1 - treated with insulin analogues (lispro, glargine), Group 2 - treated with human insulin preparations (regular and NPH insulin).The clinical and metabolic assessment was carried out 3 and 6 months after surgery. The study was approved by Local Ethics Committee.

Timeline

Start
2018-07-01
Primary completion
2020-12-22
Completion
2021-12-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Insulin Protein / enzyme biologic Subcutaneous
Comparator Insulin Lispro Protein / enzyme biologic Subcutaneous
Comparator Neutral protamine hagedorn insulin Protein / enzyme biologic Subcutaneous
Comparator insulin glargine Protein / enzyme biologic Subcutaneous