Human Versus Analogue Insulin in Patients After Pancreatectomy.

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

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.

Study Overview

• Status: Unknown
• Conditions: Pancreatogenous Diabetes
• Intervention / Treatment: Drug: Treatment with human insulin preparations or treatment with insulin analogues

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Jolanta B Jurczyńska, PhD; Phone Number: + 48 533 699 069; Email: jolanta.jurczynska@wum.edu.pl

Study Locations

• Poland
  • Warsaw, Poland, 02-091
    • Recruiting
    • Warsaw Medical University
    • Contact: Aneta Wojda; Phone Number: + 48 22 599 25 83; Email: kdw.csk@uckwum.pl
    • Principal Investigator: Jolanta B Jurczyńska
    • Sub-Investigator: Wojciech Korcz
    • Sub-Investigator: Gustaw Lech
    • Sub-Investigator: Sally Hammoud
    • Sub-Investigator: Waldemar Pawłowski
    • Sub-Investigator: Maciej Słodkowski
    • Sub-Investigator: Leszek Czupryniak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 90 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Patients treated with human insulin preparations; 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; 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)
Active Comparator: Patients treated with insulin analogues; 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; 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)

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Polish Society of Diabetology

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2018
• Primary Completion (Actual): December 22, 2020
• Study Completion (Anticipated): December 31, 2021

Study Registration Dates

• First Submitted: December 22, 2020
• First Submitted That Met QC Criteria: December 26, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: January 2, 2021
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: human insulin; insulin analogues
• Additional Relevant MeSH Terms: Hypoglycemic Agents; Physiological Effects of Drugs; Insulin; Insulin, Globin Zinc
• Other Study ID Numbers: Polish Society Of Diabetology

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No