RecruitingNAINTERVENTIONAL

Effect of Hyperglycaemia and Moxifloxacin on QTc Interval in T2DM

Researchers are studying people with type 2 diabetes to understand how high blood sugar and a common antibiotic, moxifloxacin, might affect their heart's electrical rhythm. Some people with diabetes already have changes in their heart rhythm, and certain medicines can make this more pronounced. This study aims to find out if moxifloxacin's effect on heart rhythm is made worse by high blood sugar or by low insulin levels in people with type 2 diabetes, especially those who are insulin resistant. The findings could help doctors better manage treatments and prevent potential heart complications. The study will involve around 24 men and women and will take place in a clinical research unit, with participants staying overnight for monitoring.

At a glance

Status

Recruiting

Phase

Sponsor

Richmond Pharmacology Limited

Enrolment target

Start

13 Apr 2023

Estimated completion

30 Dec 2025

Diabetes Type 2 Hyperglycaemia (Diabetic)QT Interval, Variation in Torsades de Pointes

What is this study about?

Diabetes is known to affect heart health, and in some cases, it can increase the risk of sudden heart problems. One way doctors look at heart health is by checking the 'QTc interval' on an electrocardiogram (ECG), which measures the electrical activity of your heart. In people with diabetes, this interval can sometimes be longer than usual, and this might be due to things like high blood sugar levels or how the body uses insulin.

We also know that certain everyday medicines, like the antibiotic moxifloxacin, can affect this QTc interval. In some people, especially those with diabetes, this effect might be more noticeable. This research builds on a previous study in type 1 diabetes, which showed that both high blood sugar and moxifloxacin together had an increased effect on the heart rhythm. Now, this study wants to see if the same thing happens in people with type 2 diabetes, particularly those whose bodies don't respond well to insulin.

The main goal is to understand if moxifloxacin's effect on your heart rhythm is made stronger when your blood sugar is high or when your body isn't using insulin efficiently. We'll also look at whether there are differences between men and women, and examine blood samples to understand the tiny biological changes that might be happening. This information is really important because it could help doctors choose the safest treatments for people with type 2 diabetes and potentially prevent serious heart issues.

Key takeaways

A study investigating heart rhythm changes in type 2 diabetes.
Will examine effects of high blood sugar and moxifloxacin (an antibiotic).
Aims to improve safety for people with type 2 diabetes taking certain medicines.
Participation involves an inpatient stay and careful monitoring.
The study will include men and women with specific type 2 diabetes criteria.

Who may be eligible?

This study is looking for both men and women between the ages of 18 and 64, who have type 2 diabetes that is generally stable. Your diabetes must be well-documented, with a specific blood sugar level range (HbA1c between 6.5% and 9.5%), and you need to show signs of being 'insulin resistant'.

Your general health will be checked with various tests to make sure you're healthy enough to take part and that nothing would interfere with the study. If you're taking certain diabetes medications, like metformin or SGLT-2 inhibitors, you might be eligible, but you'll need to stop these briefly before and during parts of the study under medical guidance.

For women who could become pregnant, special contraception rules apply to ensure safety. Women who are past menopause or have had certain surgeries are also able to 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 between 18 and 64 years old?
Do you have type 2 diabetes that is generally stable?
Has your doctor told you that you are insulin resistant?
Are you able to potentially stop certain diabetes medicines for a short time if required?
Are you willing to stay overnight for monitoring in a clinical research unit?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll visit Richmond Pharmacology Ltd. for a stay in their clinical research unit. During your stay, you'll receive different treatments at various times. These will include glucose (sugar), the antibiotic moxifloxacin, and a 'placebo' (a dummy treatment with no active drug), to see how each affects your body.

The research team will closely monitor you for any side effects and conduct various tests, such as ECGs to check your heart, and blood tests. After your initial stay, you'll have follow-up appointments as an outpatient. The exact number of visits and the total length of your involvement will be clearly explained to you.

Potential risks and benefits

Participating in this study might help researchers gain a better understanding of how certain medicines and blood sugar levels affect the heart in people with type 2 diabetes. This knowledge could ultimately improve care and safety for others with the condition. However, there are potential risks, including side effects from the study medications (moxifloxacin, glucose) and the discomfort of blood tests or other procedures. You will be closely monitored for any adverse effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

Richmond Pharmacology Ltd.
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'QTc interval'?

The QTc interval is a measurement on an ECG (a heart tracing) that shows how long it takes for the electrical system of your heart to recharge after each beat. A prolonged QTc interval can sometimes mean there's a higher risk of irregular heart rhythms.

What is moxifloxacin?

Moxifloxacin is a type of antibiotic often used to treat various bacterial infections, such as those affecting the lungs or skin.

What does 'insulin resistance' mean?

Insulin resistance means your body's cells don't respond as well as they should to insulin, a hormone that helps sugar get into your cells for energy. This can lead to higher blood sugar levels.

Will I have to stop my diabetes medication?

If you're taking certain diabetes medications, you might need to temporarily stop them for a period before and during the study. This will be carefully managed and explained by the study doctors.

What is a 'placebo'?

A placebo is an inactive substance or treatment that looks exactly like the real medication but has no active drug in it. It helps researchers compare the effects of the actual treatment.

How to find out more

Emma Akuffo

e.akuffo@richmondpharmacology.com +442070425800 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.