Human Versus Analogue Insulin in Patients After Pancreatectomy.

Phase 4

• Conditions: Pancreatogenous Diabetes
• Interventions: Drug: Treatment with human insulin preparations or treatment with insulin analogues

• Registration Number: NCT04690309
• Lead Sponsor: Polish Society of Diabetology

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-07-01
• Status Verified: 2020-12
• Primary Completion: 2020-12-22
• Study First Submitted: 2020-12-22
• Study First Submitted QC: 2020-12-26
• Study First Posted: 2020-12-30
• Last Update Submitted: 2021-01-02
• Last Update Posted: 2021-01-05
• Study Completion: 2021-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Patients treated with human insulin preparations	Treatment with human insulin preparations or treatment with insulin analogues	Treatment with human regular insulin administered subcutaneously before breakfast, lunch and supper and with Neutral Protamine Hagedorn insulin (isofane insulin) administered subcutaneously before sleep.
Patients treated with insulin analogues	Treatment with human insulin preparations or treatment with insulin analogues	Treatment with insulin analogues lispro administered subcutaneously before breakfast, lunch and supper and with glargine administered subcutaneously before sleep.

Primary Outcome Measures

Name	Time	Method
Metabolic control in patients treated with human insulin preparations insulin vs insulin analogues.	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	Metabolic control in patients treated with human insulin and insulin analogues will be assessed using glycated hemoglobin concentration (mmol/mol)

Secondary Outcome Measures

Name	Time	Method
Metabolic control in patients treated with human insulin preparations insulin vs insulin analogues.	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	Metabolic control in patients treated with human insulin and insulin analogues will be assessed using glycated hemoglobin concentration (mmol/mol)

Trial Locations

Locations (1)

Warsaw Medical University; 🇵🇱 Warsaw, Poland