AuthorisedTherapeutic confirmatory (Phase III)Interventional

Efficacy of domperidone (a prokinetic agent) on time in range in digestively asymptomatic type I diabetic patients with delayed gastric emptying

This study is investigating if a medication called domperidone improves blood sugar control in adults with Type 1 diabetes who also experience slow stomach emptying (a condition sometimes called gastroparesis). Having slow stomach emptying can make it harder to keep blood sugar levels steady. The researchers want to find out if taking domperidone helps these patients spend more time with their blood sugar levels within a healthy target range. They will compare domperidone to a dummy pill (placebo) over 14 days. This research is important because better blood sugar control can reduce the risk of diabetes-related complications, and finding new ways to achieve this for people with gastroparesis is very helpful.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Centre Hospitalier Universitaire Rouen

Enrolment target

270

Start

17 Sep 2024

Type 1 Diabetic patients

What is this study about?

This study is for adults who have Type 1 diabetes and also experience a condition called gastroparesis. Gastroparesis means that your stomach takes longer than usual to empty its contents into your intestines. For people with Type 1 diabetes, this can make it very difficult to manage blood sugar levels, as food isn't absorbed at a predictable rate, leading to unexpected highs and lows.

The main goal of this research is to see if a medication called domperidone can help improve blood sugar control in these patients. Domperidone is a drug that can help speed up the movement of food through your digestive system. The researchers want to find out if, by helping the stomach empty more normally, domperidone can help people with Type 1 diabetes spend more time with their blood sugar levels within a healthy range, often called the 'Time in Range'.

Participants will take either domperidone or a placebo (a dummy pill with no active ingredient) for 14 days. The study will carefully measure various aspects of blood sugar control and how well the treatment is tolerated. If domperidone proves effective, it could offer a new way for people with Type 1 diabetes and gastroparesis to achieve better, more stable blood sugar levels, potentially improving their overall health and quality of life.

Key takeaways

This study evaluates domperidone for Type 1 diabetes with slow stomach emptying (gastroparesis).
It aims to improve blood sugar control by increasing 'Time in Range'.
Participants will take either domperidone or a placebo for 14 days.
The study includes adults aged 18+ who have Type 1 diabetes and confirmed slow stomach emptying.
Your blood sugar levels and general health will be closely monitored throughout.

Who may be eligible?

This study is looking for adults aged 18 and over, of any gender. You would need to have been diagnosed with Type 1 diabetes.

Crucially, you would also need to have slow stomach emptying, which is a condition sometimes called gastroparesis, even if you don't have obvious symptoms like nausea or vomiting. The study is specifically designed for people whose blood sugar control isn't as good as it could be, despite their current treatment for diabetes.

Before joining, doctors will check your medical history to make sure the study is a safe and suitable option for you. Not everyone with Type 1 diabetes or gastroparesis will be able to take part due to other health conditions or medications.

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 1 diabetes?
Has a doctor told you that you have delayed stomach emptying (gastroparesis), even if you don't have symptoms?
Is your current blood sugar control not as good as you and your doctor would like?
Are you able to attend regular clinic visits and have your blood sugar monitored?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would be assigned to either receive the study drug (domperidone) or a dummy pill (placebo) for 14 days. Neither you nor your study doctor will know which one you are receiving. Over this period, you will have your blood sugar levels closely monitored. This will likely involve using a continuous glucose monitor (CGM) to track your blood sugar throughout the day and night.

You would have several visits to the clinic both before, during, and after the 14-day treatment period. These visits might involve blood tests (including checks for HbA1c and fructosamine, which show average blood sugar levels), measurements of how quickly your stomach empties, and discussions about how you are feeling and any side effects you might experience. They will also collect information about your daily insulin doses. The total duration of your involvement in the study, including all follow-up appointments, would be explained to you in detail by the research team.

Potential risks and benefits

Participating in this study might offer you the potential benefit of improved blood sugar control if domperidone proves effective for you. This could lead to a better quality of life and potentially reduce the risk of diabetes complications. However, there's also a chance you might receive the placebo and not experience any direct benefits from the study drug. All medications have potential side effects; domperidone can have side effects, and these will be fully explained to you before you agree to take part. Researchers will closely monitor your health throughout the study. Remember, your participation is completely voluntary, and you have the right to withdraw from the study at any time without 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
France

Common questions

What is 'gastroparesis'?

Gastroparesis means your stomach empties food much slower than it should, making blood sugar control difficult, especially for people with diabetes.

What is 'Time in Range'?

Time in Range (TIR) is the percentage of time your blood sugar levels stay within a healthy, target range (usually 70-180 mg/dL) as agreed with your doctor.

Will I know if I'm getting the real drug or a dummy pill?

No, this is a 'blinded' study. To keep the results fair, neither you nor the doctors will know if you're taking domperidone or a placebo until the study is over.

How long will I be taking the study medication?

You would take either the domperidone or the placebo tablets for 14 days during the study.

What are the main measurements in this study?

The main thing being measured is how much time your blood sugar levels spend within a healthy target range over 14 days, comparing those taking domperidone to those on placebo.