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Study on the Effectiveness and Safety of Adding Pioglitazone to Metformin and Empagliflozin for Patients with Type 2 Diabetes with Poor Blood Sugar Control

Fast replyRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying Type 2 diabetes mellitus, a condition where the body does not use insulin properly, leading to high blood sugar levels. The study will evaluate the effectiveness and safety of adding Pioglitazone to a treatment plan that already includes Metformin and Empagliflozin. These medications are taken as tablets and are used to help control blood sugar levels in people with type 2 diabetes.

The purpose of the study is to see if adding Pioglitazone can improve blood sugar control in patients who are not achieving desired results with their current treatment of Metformin and Empagliflozin. Participants will be randomly assigned to receive either the combination of all three medications or a combination of Metformin and Empagliflozin with a placebo. The study will be conducted over several weeks, with regular check-ups to monitor blood sugar levels and overall health.

Throughout the study, participants will continue their treatment and attend scheduled visits to assess their progress. The study aims to provide valuable information on whether the addition of Pioglitazone can offer better control of blood sugar levels in people with type 2 diabetes who are not responding adequately to their current medication regimen.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the participant will begin with a stabilization and washout period. This period lasts 12 weeks for those who have not previously taken diabetes medication and 8 weeks for those who have.
During this time, the participant will continue their current diabetes treatment without any changes in dosage or administration method.
Step 2
Initial treatment phase
The participant will start the initial treatment phase, which involves taking a combination of metformin and empagliflozin orally. The dosage of empagliflozin will be 10 mg.
This phase aims to evaluate the effectiveness of the current treatment regimen in managing blood sugar levels.
Step 3
Combination therapy phase
If the participant's blood sugar levels are not adequately controlled, they will enter the combination therapy phase.
In this phase, pioglitazone will be added to the existing treatment of metformin and empagliflozin. The empagliflozin dosage may be increased to 25 mg if necessary.
The participant will continue to take these medications orally.
Step 4
Monitoring and assessment
Throughout the study, the participant's blood sugar levels, including HbA1c and fasting plasma glucose, will be monitored at regular intervals, specifically at weeks 12 and 24.
Other health indicators such as cholesterol levels, liver function, body weight, blood pressure, heart rate, and waist circumference will also be assessed.
Step 5
Completion of the study
The study will conclude after 24 weeks of treatment.
The primary goal is to observe changes in HbA1c levels from the start of the study to the end of the treatment period.

Who can join the trial?

7 criteria

Must be an adult at the time of signing the Informed Consent Form. The age of adulthood varies by country, but it is 19 years or older in some places and 18 years or older in others.
Must have been diagnosed with Type 2 diabetes mellitus (T2DM).
Must have a specific range of HbA1c levels, which is a measure of blood sugar control, at the first visit. If you haven't taken diabetes medication before or only took Metformin, your HbA1c should be between 7.5% and 11%. If you have taken Metformin with other diabetes pills, your HbA1c should be between 7.0% and 11%.
Must continue the same diabetes treatment without changing the dose or method during a stabilization period. Your HbA1c should be between 7.0% and 11% at the second visit.
Must have a Body Mass Index (BMI) of 45.0 kg/m² or less at the first and third visits. BMI is a measure of body fat based on height and weight.
Must take the study medication as directed, with a compliance rate between 70% and 120% at the second and third visits.
Must voluntarily sign a written consent form after being fully informed about the study's goals, methods, and effects.

Who cannot join the trial?

6 criteria

Patients who do not have Type 2 diabetes mellitus (T2DM) cannot participate. This is a condition where the body does not use insulin properly, leading to high blood sugar levels.
Patients who are not taking Metformin and Empagliflozin as part of their current treatment cannot participate. Metformin is a medication that helps control blood sugar levels, and Empagliflozin is a medication that helps the kidneys remove sugar from the body.
Patients who are not experiencing inadequate glycemic control cannot participate. This means their current treatment is not effectively managing their blood sugar levels.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important for eligibility.
Both male and female patients are eligible, so gender is not a reason for exclusion.
Patients who are part of a vulnerable population cannot participate. This typically includes groups like children, pregnant women, or those unable to give consent.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
Centrum Badan Klinicznych Pi-House Sp. z o.o.
Gdansk, Poland
Verified
Ko-Med Centra Kliniczne Sp. z o.o.
Zamosc, Poland
Responsive
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Lodz, Poland

Trial locations

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Investigated drugs

Metformin
is a medication commonly used to help control blood sugar levels in people with type 2 diabetes. It works by decreasing the amount of sugar produced by the liver and improving the body's response to insulin.
Empagliflozin
is a medication that helps lower blood sugar levels in people with type 2 diabetes. It works by helping the kidneys remove sugar from the body through urine. In this trial, it is used in combination with Metformin to improve blood sugar control.
Pioglitazone
is a medication used to help control blood sugar levels in people with type 2 diabetes. It works by making the body's cells more sensitive to insulin, which helps the body use sugar more effectively. In this trial, it is added to the combination of Metformin and Empagliflozin to evaluate its additional benefits in controlling blood sugar.

What is already known about the treatment

Pioglitazone – Pioglitazone is administered orally in tablet form and is currently being studied in clinical trials for its effectiveness in treating type 2 diabetes mellitus. It is often used in combination with other diabetes medications like Metformin and Empagliflozin to improve blood sugar control in patients who do not achieve adequate results with Metformin and Empagliflozin alone. Pioglitazone works by increasing the body's sensitivity to insulin, helping to lower blood sugar levels. It belongs to the pharmacological class of thiazolidinediones, which are known for their role in managing blood glucose levels in diabetes patients.

Investigated diseases

Type 2 Diabetes Mellitus – This is a chronic condition that affects the way the body processes blood sugar (glucose). In type 2 diabetes, the body either resists the effects of insulin, a hormone that regulates the movement of sugar into cells, or doesn't produce enough insulin to maintain normal glucose levels. Over time, high blood sugar levels can lead to various complications, affecting the heart, blood vessels, nerves, eyes, and kidneys. The disease often develops slowly, and individuals may not notice symptoms initially. Common symptoms include increased thirst, frequent urination, hunger, fatigue, and blurred vision. As the condition progresses, it may require lifestyle changes and medication to manage blood sugar levels effectively.