Human Versus Analogue Insulin in Patients After Pancreatectomy.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2021-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study on Pancreatic Islets in Patients Undergoing (Partial) Pancreatectomy (PRECISE)

NCT06150690

Diabetes Mellitus

RECRUITING

The Role of Pulsatile Insulin Secretion (A Study Investigating the Effects of Partial Pacreatectomy on Glucose Metabolism)

NCT00841867

Impaired Glucose Tolerance

COMPLETED

Treatment of Type 2 Diabetes Mellitus by Duodenal Exclusion Associated With Omentectomy: Clinical and Hormonal Study

NCT00566215

Diabetes Mellitus, Type 2 Insulin Resistance Obesity

TERMINATED PHASE1/PHASE2

Effect of the Omentectomy on the Hyperglycemia and the Resistance to the Insulin in Patients With Morbid Obesity

NCT00454597

Obesity Diabetes Mellitus Type 2

COMPLETED EARLY_PHASE1

The Effect of Insulin-induced Hypoglycaemia on Gut-derived Glucagon Secretion (Px-Hypo)

NCT04064203

Diabetes After Total Pancreatectomy

COMPLETED NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pancreatogenous Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Treatment with human insulin preparations or treatment with insulin analogues

Intervention Type 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 insulin analogues

Treatment with insulin analogues lispro administered subcutaneously before breakfast, lunch and supper and with glargine administered subcutaneously before sleep.

Group Type ACTIVE_COMPARATOR

Treatment with human insulin preparations or treatment with insulin analogues

Intervention Type 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)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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)

Intervention Type DRUG