NCT04690309

Human Versus Analogue Insulin in Patients After Pancreatectomy.

Human Versus Analogue Insulin in Patients After Pancreatectomy - Open, Prospective, Randomized, Intervention Study.

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 100 (estimated)
• Sponsor: Polish Society of Diabetology · Academic / Other
• Sex: All
• Age: 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pancreatogenous Diabetes

Interventions

Type	Name	Description
DRUG	Treatment with human insulin preparations or treatment with insulin analogues	The doses of human insulin preparations and insulin analogues will be matched individually to achieve target values of blood glucose - fasting \< 100 mg/dl (5.5 mmol/L) and postprandial \< 140 mg/dl (7.8mmol/L)

Timeline

• Start date: 2018-07-01
• Primary completion: 2020-12-22
• Completion: 2021-12-31
• First posted: 2020-12-30
• Last updated: 2021-01-05

Locations

1 site across 1 country: Poland