Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Multicentre, Randomized, Double-blind, Placebo-controlled, phase III study to evaluate the efficacy and safety of Pioglitazone co-administration in patients with type II diabetes with insufficient glycemic control with Metformin and Empagliflozin combination therapy

This study is for people with Type 2 diabetes whose blood sugar isn't well controlled, even with their current medicines (Metformin and Empagliflozin). We want to find out if adding another medication, Pioglitazone, can help lower blood sugar levels further. The study will also carefully check for any side effects of this new combination. Participants will be given either Pioglitazone or a dummy pill (placebo) alongside their usual treatment in a 'blinded' way, meaning neither they nor their doctors will know which they are taking. We'll be measuring blood sugar over 24 weeks to see how effective and safe this additional medicine is.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Celltrion Inc.

Enrolment target

224

Start

27 May 2024

Type 2 diabetes mellitus (T2DM)

What is this study about?

This study is focused on people who have Type 2 diabetes. If you're managing this condition, you know how important it is to keep your blood sugar levels in a healthy range. Sometimes, even with established medications like Metformin and Empagliflozin, blood sugar can still be a bit too high. This study is exploring a way to potentially improve that control.

Researchers want to see if adding another medication called Pioglitazone to the Metformin and Empagliflozin combination helps to lower blood sugar more effectively. They will also be closely monitoring to ensure that this combination of medicines is safe and doesn't cause unexpected side effects. This is a very common approach in medical research to find new and better ways to treat conditions.

This important research is in 'Phase III', which means it's a larger study designed to confirm how well and how safely a new treatment works, comparing it to existing approaches or a dummy treatment. The goal is to gather strong evidence to make sure any new treatment is both helpful and safe for people with Type 2 diabetes.

Key takeaways

This study evaluates adding Pioglitazone to existing Type 2 diabetes treatment (Metformin + Empagliflozin).
It aims to improve blood sugar control and assess the safety of this new combination.
Participants will receive either Pioglitazone or a placebo for 24 weeks.
Regular health checks, including blood tests and measurements, will be carried out.
The study is for adults with Type 2 diabetes whose blood sugar isn't fully controlled.

Who may be eligible?

This study is for adults, aged 18 or older, who have been diagnosed with Type 2 diabetes.

To be considered, your diabetes shouldn't be fully controlled by your current medications, which must include a combination of Metformin and Empagliflozin. You might also be taking other diabetes medications like Glimepiride, Gliclazide, or Glipizide, but the core requirement is that Metformin and Empagliflozin are part of your current treatment plan.

There will be other detailed health checks to make sure the study is right for you and safe. This includes looking at your other medical conditions and any other medications you take. Both men and women can take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Do you have Type 2 diabetes?
Are you currently taking Metformin and Empagliflozin for your diabetes?
Do you feel your current diabetes treatment isn't controlling your blood sugar as well as it could be?
Are you willing to attend regular clinic visits for 24 weeks?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will continue with your Metformin and Empagliflozin. You will then be randomly chosen to receive either Pioglitazone or a dummy pill (placebo) alongside your existing treatment. Neither you nor your study doctor will know which you are taking. This is done to ensure the study results are as fair and accurate as possible.

Over 24 weeks, you will have regular visits to the clinic for various health checks. These will include blood tests to measure your blood sugar levels (like HbA1c, which shows your average blood sugar over a few months, and fasting plasma glucose), cholesterol, and liver function. We'll also check your weight, blood pressure, heart rate, and waist size.

You might need to answer questions about how you're feeling and whether you've experienced any side effects. The total duration of active treatment and follow-up for this study is 24 weeks.

Potential risks and benefits

Taking part in this study might offer the potential benefit of improved blood sugar control if adding Pioglitazone is effective for you. You will also receive close medical attention and monitoring throughout the study. However, like all medications, Pioglitazone can have side effects, and some people might experience them. As with any medical study, there's a chance the treatment may not work for you, or you might receive the placebo. Your health and safety are paramount, and you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Poland

Common questions

What is Type 2 diabetes?

Type 2 diabetes is a common condition where the body either doesn't produce enough insulin or the insulin it does produce isn't used effectively, leading to high blood sugar levels.

What is HbA1c?

HbA1c is a blood test that shows your average blood sugar levels over the past 2-3 months. It's a key indicator of how well your diabetes is being managed.

What does 'double-blind' mean?

Double-blind means neither you nor your study doctor will know whether you are receiving the active study drug (Pioglitazone) or a dummy pill (placebo). This helps make the study fair and unbiased.

Why is this study necessary?

This study aims to discover if adding Pioglitazone can further improve blood sugar control for people with Type 2 diabetes who are already on Metformin and Empagliflozin, and if it's safe to do so.

Will I have to pay to join the study?

No, you will not have to pay to participate in the study. All study medications and assessments will be provided.