Study on Insulin Lispro and Insulin Human for Managing Blood Sugar After Meals in Type 1 Diabetes Patients with Different Gastric Emptying Rates

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What is this study about?

This clinical trial is focused on studying the effects of different fast-acting insulin treatments for individuals with Type 1 Diabetes. The insulins being tested include Lyumjev, Humalog, and Huminsulin. These insulins are designed to help manage blood sugar levels after meals. The main goal of the study is to find the best insulin option that can help control blood sugar levels effectively after eating, while also considering how quickly the stomach empties food into the intestines.

Participants in the study will receive one of the insulin treatments through a subcutaneous injection, which means the insulin is injected under the skin. The study will observe how these insulins affect blood sugar levels after meals and how they might influence the production of certain substances in the body that can cause stress to cells, known as reactive oxygen species. The study will also look at how the speed of stomach emptying affects blood sugar control with these insulins.

The trial will take place over a period of time, during which participants will be monitored to see how their blood sugar levels respond to the different insulin treatments. The study aims to provide insights into which insulin works best for people with Type 1 Diabetes, depending on how quickly their stomachs empty food. This information could help improve the management of blood sugar levels and reduce the risk of complications associated with high blood sugar.

1 joining the study

Upon joining the study, eligibility is confirmed based on criteria such as having type 1 diabetes, an HbA1c level between 6.0% and 8.0%, being in generally good health, aged between 18 and 80 years, and having a body mass index (BMI) between 18.5 and 35 kg/m².

2 initial assessment

An initial assessment is conducted to evaluate health status and establish baseline measurements. This includes measuring blood glucose levels and assessing gastric emptying rates.

3 medication administration

Participants receive one of the following insulin preparations: Lyumjev 100 units/mL, Humalog 100 units/mL, or Huminsulin Normal 100 units/mL. These are administered via subcutaneous injection before meals.

The dosage and frequency are determined based on individual needs and the specific insulin preparation used.

4 monitoring and data collection

Regular monitoring of blood glucose levels is conducted to assess the effects of the insulin on post-meal blood sugar levels.

Data on the formation of reactive oxygen species and other metabolic parameters are collected to evaluate the impact of the insulin.

5 evaluation of results

The primary goal is to optimize post-meal blood glucose levels by selecting the most suitable rapid-acting insulin based on gastric emptying speed.

Secondary evaluations include comparing the effects of different insulins on oxidative stress markers and other metabolic responses.

6 completion of the study

The study is expected to conclude by November 30, 2025. Final assessments are conducted to evaluate the overall outcomes and effectiveness of the insulin treatments.

Who Can Join the Study?

You must have Type 1 Diabetes.
Your HbA1c level, which is a measure of your average blood sugar over the past 2 to 3 months, should be between 6.0% (42 mmol/l) and 8.0% (64 mmol/l).
You should be in generally good overall health.
Your age must be between 18 and 80 years old.
Your Body Mass Index (BMI), which is a measure of body fat based on height and weight, should be between 18.5 and 35 kg/m².

Who Cannot Join the Study?

Individuals who do not have Type 1 Diabetes cannot participate.
Participants must be within the specified age range, which is not detailed here.
Both males and females are eligible, so gender is not a reason for exclusion.
Individuals considered part of a vulnerable population are not excluded, meaning those who might need special protection are not automatically disqualified.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Katholisches Klinikum Bochum gGmbH	Bochum	Germany

Trial status

Country	Status	Recruitment Start
Germany	Not recruiting	01.05.2024

Trial locations

Investigated drugs:

Insulin Lispro is a fast-acting insulin used to control blood sugar levels in people with type 1 diabetes. It is typically taken before meals to help manage the rise in blood sugar that occurs after eating. In this trial, it is being studied to see how it affects blood sugar levels and oxidative stress in people with different rates of gastric emptying.

Insulin Aspart is another rapid-acting insulin that helps manage blood sugar spikes after meals. It works quickly to lower blood sugar levels and is being evaluated in this study to determine its effectiveness in individuals with varying gastric emptying speeds.

Insulin Glulisine is also a fast-acting insulin used to control post-meal blood sugar levels. This trial is examining its role in optimizing blood sugar control and reducing oxidative stress in people with type 1 diabetes, depending on how quickly their stomach empties food.

Investigated diseases:

Type 1 diabetes mellitus

Type 1 Diabetes – Type 1 Diabetes is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. It typically appears in adolescence or early adulthood, but it can develop at any age. The disease progresses as the immune system mistakenly attacks and destroys insulin-producing cells in the pancreas. This leads to high blood sugar levels, which can cause symptoms like increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, if not managed properly, it can lead to complications affecting the heart, nerves, eyes, and kidneys. The management of Type 1 Diabetes involves monitoring blood sugar levels and administering insulin to maintain normal glucose levels.

Trial ID:

2023-509217-37-00

Protocol code:

KKB_2023_FActIn-T1DM

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study on Insulin Lispro and Insulin Human for Managing Blood Sugar After Meals in Type 1 Diabetes Patients with Different Gastric Emptying Rates

What is this study about?

Who Can Join the Study?

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