Human Versus Analogue Insulin in Patients After Pancreatectomy.

NCT04690309 | Unknown Phase 4

• 1 other identifier: Polish Society Of Diabetology
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Pancreatogenous Diabetes

Keywords

human insulin; insulin analogues

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Patients treated with human insulin preparations

ACTIVE COMPARATOR

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

Patients treated with insulin analogues

ACTIVE COMPARATOR

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

Interventions

Treatment with human insulin preparations or treatment with insulin analogues DRUG

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)

Patients treated with human insulin preparations; Patients treated with insulin analogues

Eligibility Criteria

• Age: Up to 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Active psychiatric disease not amenable to treatment and hindering cooperation

Sponsors & Collaborators

• Polish Society of Diabetology: lead

Study Sites (1)

Warsaw Medical University

Warsaw, 02-091, Poland

RECRUITING

MeSH Terms

Conditions

Insulin Resistance

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Central Study Contacts

Jolanta B Jurczyńska, PhD

CONTACT

+ 48 533 699 069; jolanta.jurczynska@wum.edu.pl

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 22, 2020
• First Posted: December 30, 2020
• Study Start: July 1, 2018
• Primary Completion: December 22, 2020
• Study Completion: December 31, 2021
• Last Updated: January 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share

Locations

PL (1)