Human Versus Analogue Insulin in Patients After Pancreatectomy.

NCT04690309 PHASE4 UNKNOWN

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.

Details

Lead sponsor	Polish Society of Diabetology
Phase	PHASE4
Status	UNKNOWN
Enrolment	100
Start date	Sun Jul 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Completion	Fri Dec 31 2021 00:00:00 GMT+0000 (Coordinated Universal Time)

Conditions

• Pancreatogenous Diabetes

Interventions

• Treatment with human insulin preparations or treatment with insulin analogues

Countries

Poland