Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

GALOP: Oral Glibenclamide in premature hyperglycemia

The GALOP study is exploring a new way to help very premature babies who develop temporary high blood sugar. This condition, called transient hyperglycaemia, means their blood sugar levels are too high. Doctors are testing a liquid medicine, AMGLIDIA (containing glibenclamide), given by mouth. The main goal is to see if this medicine can keep blood sugar levels stable for 72 hours, stopping the need for insulin injections and avoiding dangerously low blood sugar levels. Researchers will also look at how quickly babies' sugar levels respond, how long they need the medicine, their growth, and any side effects. Ultimately, they want to find out if this oral medicine is a safe and effective option for these tiny patients.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

Start

24 Jun 2024

Transient hyperglycaemia in premature infants

What is this study about?

This study, called GALOP, is investigating a medicine to help very premature babies who get high blood sugar levels shortly after birth. This condition, known as 'transient hyperglycaemia,' means their bodies are temporarily having trouble managing sugar. Sometimes, premature babies need help to get their sugar levels back to normal, and doctors often use insulin for this. This study is testing if a different medicine, called glibenclamide, given as a liquid by mouth, can be a good alternative.

The main aim is to see if glibenclamide can keep a baby's blood sugar stable for 72 hours without them needing insulin. The doctors will carefully watch the babies to make sure their blood sugar doesn't go too low, which can also be dangerous. They'll be checking how well the medicine works to control sugar levels, how long babies need to take it, and how it might affect their growth and overall health.

Researchers will also be looking closely at any potential side effects of the medicine. They want to understand if it's generally safe for these fragile babies. An important part of the study is also to see how easy the medicine is for nurses and parents to give. This helps doctors decide if it's a practical and helpful treatment option for premature babies in the future.

Key takeaways

The study explores an oral medicine (glibenclamide) for high blood sugar in premature babies.
It aims to see if this medicine can replace insulin injections for temporary high blood sugar.
Researchers will monitor blood sugar control, safety, and ease of use.
The main goal is to keep blood sugar stable for 72 hours without needing insulin.
Helps understand if this could be a new, gentler treatment option for premature babies.

Who may be eligible?

This study is looking for premature babies who have temporary high blood sugar levels. To join, a baby would need to have been born early and be experiencing blood sugar levels that are higher than normal. The medical team would determine if the baby fits the specific health criteria for the study.

There are no age restrictions within the premature baby group, meaning babies of any gestation within the premature range could be considered if they meet the other health requirements. Both baby boys and baby girls can take part. The healthcare team caring for your premature baby would be able to tell you if your baby might be suitable for this research.

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.

Is my baby premature?
Does my baby currently have higher-than-normal blood sugar levels?
Has my baby's doctor suggested they might be suitable for this specific type of blood sugar control study?
Am I comfortable with my baby potentially receiving a new oral medicine?

Answer every question to see your result.

What does participation involve?

If your baby takes part in this study, they would receive the study medicine, AMGLIDIA, given by mouth. The main focus is on the first 72 hours of treatment, where their blood sugar levels would be very carefully monitored using tiny blood samples, usually from a heel prick. Nurses and doctors would regularly check your baby's blood sugar to see how the medicine is working and to make sure it's not too low.

Throughout the study, medical staff would also keep track of your baby's feeding, growth, and overall health. They would look out for any changes and record how your baby is responding to the treatment. There would also be checks when your baby reaches about 36 weeks after conception to see how they are developing. The study team would explain all the details, including how often checks would happen and the total time your baby would be involved.

Potential risks and benefits

Taking part in any study has potential benefits and risks. Your baby might benefit from receiving a new oral treatment that could help control their blood sugar without needing insulin injections. The information gathered could also help other premature babies in the future. However, there's always a risk that the medicine might not work as expected, or that your baby could experience side effects. Your baby's health would be closely monitored by medical professionals to manage any risks. Remember, taking part in a study is completely voluntary, and you have the right to withdraw your baby at any time, for any reason, without it affecting their 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
France

Common questions

What does 'transient hyperglycaemia' mean?

It means your baby has high blood sugar levels for a short time, which is common in very premature babies.

What is glibenclamide?

It's a medicine being tested in this study to help control high blood sugar. It's given as a liquid by mouth.

Will my baby still get insulin?

This study is trying to see if glibenclamide can control blood sugar well enough so that insulin is not needed. However, if your baby's blood sugar isn't well controlled, they may still need insulin.

What are the main things doctors are looking for?

They want to know if glibenclamide can keep blood sugar stable for 72 hours without insulin, prevent very low sugar, and if it's safe.

Will this study affect my baby's usual care?

No, your baby will continue to receive the standard high-quality care, with the study medicine being an additional part of their treatment if you agree.