Human Versus Analogue Insulin in Patients After Pancreatectomy.

Polish Society of Diabetology

Status and phase: Unknown; Phase 4

Conditions: Pancreatogenous Diabetes

Treatments: Drug: Treatment with human insulin preparations or treatment with insulin analogues

Study type: Interventional

Funder types: Other

Identifiers

NCT04690309

Polish Society Of Diabetology

Details and patient eligibility

About

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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Patients treated with human insulin preparations

Active Comparator group

Description:

Treatment with human regular insulin administered subcutaneously before breakfast, lunch and supper and with Neutral Protamine Hagedorn insulin (isofane insulin) administered subcutaneously before sleep.

Treatment:

Drug: Treatment with human insulin preparations or treatment with insulin analogues

Patients treated with insulin analogues

Active Comparator group

Description:

Treatment with insulin analogues lispro administered subcutaneously before breakfast, lunch and supper and with glargine administered subcutaneously before sleep.

Treatment:

Drug: Treatment with human insulin preparations or treatment with insulin analogues