Study on the Safety of A24110He for Patients with Type 2 Diabetes and High Triglycerides

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What is this study about?

This clinical trial is focused on studying the safety and local effects of a new treatment called A24110He in people with type 2 diabetes who also have high levels of fats called triglycerides in their blood. The study aims to understand how the body handles this treatment and whether it is safe for use. Participants will receive the treatment through a method called subcutaneous injection, which means it is injected under the skin.

During the trial, participants will receive four weekly doses of A24110He. Some participants will receive a placebo instead. The trial will monitor participants’ health through regular check-ups, including physical exams and tests to measure vital signs like blood pressure and heart rate. Blood tests will also be conducted to check various health markers, such as kidney and liver function, blood sugar levels, and other important indicators.

The trial will also measure the levels of A24110He in the blood to understand how the body processes the treatment. This includes determining the highest concentration of the treatment in the blood and how long it stays in the body. The study is expected to provide valuable information about the safety and potential benefits of A24110He for people with type 2 diabetes and high triglycerides.

1 initial assessment

Upon joining the trial, an initial assessment is conducted to ensure eligibility. This includes a physical examination, vital signs check, and laboratory tests to evaluate overall health and specific conditions related to type 2 diabetes and triglyceride levels.

2 baseline measurements

Baseline measurements are taken to establish a starting point for the trial. These include fasting plasma glucose levels, triglyceride levels, and other relevant health indicators.

3 first administration of A24110He

The first dose of A24110He is administered via subcutaneous injection. This is done under controlled conditions to monitor any immediate reactions and ensure safety.

4 weekly administrations

The trial involves four weekly administrations of A24110He. Each dose is given through subcutaneous injection, and the patient is monitored for any side effects or adverse reactions.

5 monitoring and follow-up

Throughout the trial, regular monitoring is conducted. This includes checking vital signs, conducting laboratory tests, and assessing the local tolerability of the medication. The patient is also asked to report any adverse events.

6 final assessment

At the end of the trial, a final assessment is performed. This includes a comprehensive physical examination, laboratory tests, and evaluation of the overall health status to determine the effects of the treatment.

Who Can Join the Study?

You must provide signed and dated written consent before any trial-specific procedures begin.
You need to have access to and be familiar with equipment for checking your own blood sugar levels.
Your blood sugar control should be safe, as determined by the trial doctor.
You must have suitable veins for blood tests, as decided by the trial doctor.
You should be willing to follow the trial procedures and any restrictions.
You must be between 18 and 75 years old.
If you are a woman who can have children, you must have a negative pregnancy test at the start and use a highly effective birth control method. If you are a man who is sexually active and not surgically sterile, you must ensure your female partner uses birth control or avoid sexual intercourse during the trial and for 180 days after the last dose of the trial medication.
Your body mass index (BMI) should be less than 38 kg/m², and you must weigh at least 56 kg.
You need to have documented high levels of triglycerides (a type of fat in the blood) of at least 2.5 mmol/L before the trial starts. Any medication you take to lower lipids (fats) must have been stable for at least 3 months before the trial. Stable treatment means the dose and type of medication have not changed, although you can switch products if the active ingredient is the same.
Your fasting triglyceride levels must be at least 2.5 mmol/L at the first visit.
You must have been diagnosed with type 2 diabetes for at least 6 months and be on stable medication to lower blood sugar (such as metformin, sulfonylurea, glitazones, DPP4-inhibitors, GLP-1 agonists, SGLT2-inhibitors, repaglinide) for 3 months before the fourth visit. Stable treatment means the dose and type of medication have not changed, although you can switch products if the active ingredient is the same. A diagnosis of type 2 diabetes is confirmed by either a formal diagnosis in your medical record or documented high blood sugar levels that meet the criteria for type 2 diabetes.

Who Cannot Join the Study?

Patients who do not have Type 2 diabetes with moderate to severe hypertriglyceridemia cannot participate. Hypertriglyceridemia means having high levels of fats called triglycerides in the blood.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are not part of the specified clinical trial group cannot participate. This means the study is looking for a specific group of people.
Patients who are not either male or female cannot participate, as the study includes both genders.
Patients who are considered part of a vulnerable population cannot participate. A vulnerable population includes people who might need special protection or care.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Region Stockholm – SLSO	Stockholm	Sweden
Karolinska University Hospital	Solna	Sweden
CTC Clinical Trial Consultants AB	Uppsala	Sweden
Akardo AB	Stockholm	Sweden
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen	Gothenburg	Sweden
Vjpcooij Rucuedfu Hgnqzxvm	Vasteras	Sweden

Trial status

Country	Status	Recruitment Start
Sweden	Not recruiting	01.02.2024

Trial locations

Investigated drugs:

A24110He is a medication being studied for its safety and how well it is tolerated when given multiple times to people with type 2 diabetes who also have high levels of triglycerides in their blood. The trial aims to understand if this medication can be safely used in these patients and how their bodies respond to it.

Type 2 Diabetes Mellitus – This is a chronic condition that affects the way the body processes blood sugar (glucose). It is characterized by insulin resistance, where the body’s cells do not respond properly to insulin, and eventually, the pancreas may not produce enough insulin. Over time, high blood sugar levels can lead to various complications affecting the heart, kidneys, nerves, and eyes. The disease often develops gradually and may initially present with symptoms like increased thirst, frequent urination, and fatigue. As it progresses, individuals may experience more severe symptoms and complications if blood sugar levels are not managed effectively.

Hypertriglyceridemia – This condition involves having an elevated level of triglycerides in the blood, which are a type of fat. It is often associated with other conditions such as obesity, poorly controlled diabetes, and metabolic syndrome. High triglyceride levels can contribute to the hardening or thickening of artery walls, increasing the risk of cardiovascular disease. The condition may not present noticeable symptoms initially but can lead to complications like pancreatitis if levels become extremely high. Managing triglyceride levels is important to prevent associated health issues.

Trial ID:

2023-509091-42-00

Protocol code:

LGON-CT-002

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Safety of A24110He for Patients with Type 2 Diabetes and High Triglycerides

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?