Clinical trial NCT04690309: Human Versus Analogue Insulin in Patients After Pancreatectomy.
Official title: Human Versus Analogue Insulin in Patients After Pancreatectomy - Open, Prospective, Randomized, Intervention Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Pancreatogenous Diabetes
Keywords: human insulin
insulin analogues
Lead sponsor: Polish Society of Diabetology
Sponsor class: OTHER
First posted: 2020-12-30
Enrollment: 100
Sex: ALL
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

•Patients with pancreatic tumor confirmed in imaging studies and qualified for surgical treatment

Exclusion Criteria:

•Active psychiatric disease not amenable to treatment and hindering cooperation

Primary outcomes:
measure: Metabolic control in patients treated with human insulin preparations insulin vs insulin analogues.
timeFrame: Change in concentration of glycated hemoglobin from baseline to concentration of glycated hemoglobin 6 months after surgery in patients treated with human insulin and insulin analogues
Secondary outcomes:
measure: Metabolic control in patients treated with human insulin preparations insulin vs insulin analogues.
timeFrame: Change in concentration of glycated hemoglobin from baseline to concentration of glycated hemoglobin 3 months after surgery in patients treated with human insulin and insulin analogues
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: Warsaw Medical University
Study officials:
References: