Human Versus Analogue Insulin in Patients After Pancreatectomy.

• ClinicalTrials.gov Identifier: NCT04690309
• Recruitment Status: Recruiting
• First Posted: December 30, 2020
• Last Update Posted: January 5, 2021
• Sponsor: Polish Society of Diabetology
• Information provided by (Responsible Party): Polish Society of Diabetology

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Pancreatogenous Diabetes	Drug: Treatment with human insulin preparations or treatment with insulin analogues	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Human Versus Analogue Insulin in Patients After Pancreatectomy - Open, Prospective, Randomized, Intervention Study.
• Actual Study Start Date: July 1, 2018
• Actual Primary Completion Date: December 22, 2020
• Estimated Study Completion Date: December 31, 2021

Arms and Interventions

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)

Outcome Measures

Primary Outcome Measures :

1. Metabolic control in patients treated with human insulin preparations insulin vs insulin analogues. [ Time Frame: 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 :

1. Metabolic control in patients treated with human insulin preparations insulin vs insulin analogues. [ Time Frame: 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)

Eligibility Criteria

• Ages Eligible for Study: up to 90 Years (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Jolanta B Jurczyńska, PhD; + 48 533 699 069; jolanta.jurczynska@wum.edu.pl

Locations

Poland

Warsaw Medical University; Recruiting

Warsaw, Poland, 02-091

Contact: Aneta Wojda + 48 22 599 25 83 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

Sponsors and Collaborators

Polish Society of Diabetology

More Information

• Responsible Party: Polish Society of Diabetology
• ClinicalTrials.gov Identifier: NCT04690309
• Other Study ID Numbers: Polish Society Of Diabetology
• First Posted: December 30, 2020
• Last Update Posted: January 5, 2021
• Last Verified: December 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Polish Society of Diabetology:

human insulin; insulin analogues

Additional relevant MeSH terms:

Insulin; Insulin, Globin Zinc; Hypoglycemic Agents; Physiological Effects of Drugs