Study on the Effects of Empagliflozin, Pioglitazone, and Semaglutide for Patients with Type 2 Diabetes

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What is this study about?

This clinical trial is focused on studying Type 2 Diabetes, a condition where the body struggles to regulate blood sugar levels effectively. The study will compare the effects of three different medications: Empagliflozin (known as Jardiance), Pioglitazone (known as Actos), and Semaglutide (known as Rybelsus). These medications are taken orally in tablet form and are commonly used to help manage blood sugar levels in people with Type 2 Diabetes.

The purpose of the study is to understand how these medications differ in their positive effects on fat tissue function. Fat tissue, also known as adipose tissue, plays a crucial role in storing energy and regulating hormones. The study will explore how these medications might improve the way fat tissue works in people with Type 2 Diabetes. Participants will be randomly assigned to receive one of the medications or a placebo, and the study will last for a period of six months.

Throughout the study, participants will take their assigned medication daily and attend regular check-ups to monitor their health and the effects of the medication. The study aims to provide valuable insights into how these medications can benefit people with Type 2 Diabetes by improving the function of their fat tissue. This research could lead to better treatment options and improved quality of life for those living with this condition.

1 joining the study

Upon joining the study, the participant must provide written consent. Eligibility criteria include being between 30 and 70 years old, having a BMI of 25 or higher, and an HbA1c level of 42 mmol/mol or higher. Fertile women must use effective contraception throughout the study and have a negative pregnancy test before randomization.

2 randomization and medication assignment

Participants are randomly assigned to receive one of the following medications: Rybelsus (semaglutide) in doses of 3 mg, 7 mg, or 14 mg, Actos (pioglitazone) in doses of 15 mg, 30 mg, or 45 mg, or Jardiance (empagliflozin) in doses of 10 mg or 25 mg. All medications are administered orally in tablet form.

3 medication administration

Participants take the assigned medication daily. The specific dosage and duration depend on the randomization group. The study aims to compare the effects of these medications on adipose tissue function in individuals with type 2 diabetes.

4 monitoring and assessments

Throughout the study, participants undergo regular monitoring and assessments. This includes measuring lipolysis, which is the breakdown of fats, in isolated fat cells from the abdominal area. The study also examines the cellular differences in fat tissue using specific genetic tests.

5 completion of the study

The study is expected to conclude by December 31, 2026. Participants will have contributed to understanding how different diabetes medications affect fat tissue function.

Who Can Join the Study?

The participant has provided written consent to participate in the study.
Age between 30 and 70 years old.
BMI of 25 or higher. BMI stands for Body Mass Index, which is a measure of body fat based on height and weight.
HbA1c of 42 mmol/mol or higher. HbA1c is a blood test that shows average blood sugar levels over the past 2 to 3 months.
Fertile women must use effective contraception throughout the study. This includes methods like:
- Combined hormonal contraceptives (estrogen and progestogen) that stop ovulation, available as oral pills, intravaginal rings, or skin patches.
- Progestogen-only contraceptives that stop ovulation, available as oral pills, injections, or implants.
- Intrauterine device (IUD), which can be hormonal or copper-based.
- Bilateral tubal occlusion, which is a surgical procedure to block the fallopian tubes.
- Having a partner who has had a vasectomy, a surgical procedure for male sterilization.
- Practicing sexual abstinence, which means not having heterosexual intercourse during the study.
Women of childbearing potential need a negative pregnancy test at screening before starting the study.

Who Cannot Join the Study?

Individuals who do not have Type 2 Diabetes cannot participate. Type 2 Diabetes is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Participants must be within certain age ranges, typically adults and older adults.
Both men and women can participate, so gender is not a reason for exclusion.
People who are considered part of a vulnerable population, such as those who might not be able to give informed consent, are not included in this study.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Steno Diabetes Center Copenhagen	Herlev	Denmark
Karolinska University Hospital	Solna	Sweden
Agnohp Uevchaprwa Hstmzkpd	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not yet recruiting	23.01.2023
Sweden	Recruiting	23.01.2023

Trial locations

Investigated drugs:

Empagliflozin is a medication used to help control blood sugar levels in people with type 2 diabetes. It works by helping the kidneys remove glucose from the bloodstream through urine. In this trial, it is being studied to see how it affects the function of fat tissue in the body.

Pioglitazone is another medication used to treat type 2 diabetes. It helps improve the body’s sensitivity to insulin, which can lower blood sugar levels. The trial is examining how pioglitazone influences the function of fat tissue and its potential benefits for people with diabetes.

Semaglutide is a medication that helps lower blood sugar levels by mimicking a hormone in the body that increases insulin release. It is also used to help with weight loss in some patients. In this study, researchers are looking at how semaglutide affects fat tissue function in individuals with type 2 diabetes.

Investigated diseases:

Diabetes mellitus

Type 2 Diabetes – Type 2 diabetes 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 health issues, including damage to the eyes, kidneys, and nerves. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. Lifestyle factors such as obesity and physical inactivity are significant contributors to the development of type 2 diabetes.

Trial ID:

2024-513416-98-00

NCT ID:

NCT05501483

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Empagliflozin, Pioglitazone, and Semaglutide for Patients with Type 2 Diabetes

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