Human Versus Analogue Insulin in Patients After Pancreatectomy.

Study Overview
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Brief Summary
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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.

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

Conditions
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Pancreatogenous Diabetes

Intervention / Treatment
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* Drug: Treatment with human insulin preparations or treatment with insulin analogues


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Patients treated with human insulin preparations<br>Treatment with human regular insulin administered subcutaneously before breakfast, lunch and supper and with Neutral Protamine Hagedorn insulin (isofane insulin) administered subcutaneously before sleep. | Drug: Treatment with human insulin preparations or treatment with insulin analogues<br>* 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)<br>|
| Active Comparator: Patients treated with insulin analogues<br>Treatment with insulin analogues lispro administered subcutaneously before breakfast, lunch and supper and with glargine administered subcutaneously before sleep. | Drug: Treatment with human insulin preparations or treatment with insulin analogues<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic control in patients treated with human insulin preparations insulin vs insulin analogues. | Metabolic control in patients treated with human insulin and insulin analogues will be assessed using glycated hemoglobin concentration (mmol/mol) | 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolic control in patients treated with human insulin preparations insulin vs insulin analogues. | Metabolic control in patients treated with human insulin and insulin analogues will be assessed using glycated hemoglobin concentration (mmol/mol) | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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human insulin, insulin analogues