Low dosE GlibENclamide and Dapagliflozin in type 1 Diabetes (LEGEND-D)
Living with type 1 diabetes means constantly balancing insulin and food to avoid dangerous dips in blood sugar, known as 'hypos'. Normally, the body releases a hormone called glucagon to raise blood sugar when it drops too low, but this natural safety net stops working properly in type 1 diabetes. Researchers at the University of Oxford are testing whether two existing medicines, glibenclamide and dapagliflozin, can switch this safety system back on. In this study, volunteers with type 1 diabetes take low doses of these medicines and undergo closely supervised tests to see how their bodies react when blood sugar dips. A group of volunteers without diabetes will also take part for comparison. The goal is to discover new ways to help people with type 1 diabetes prevent severe hypos in the future.
Auf einen Blick
Worum geht es in dieser Studie?
In type 1 diabetes, the body cannot make insulin, so people must take insulin every day to keep their blood sugars balanced. However, insulin can sometimes cause blood sugar levels to fall dangerously low, causing what is commonly known as a 'hypo'. In a healthy body, another hormone called glucagon steps in like a backup brake, raising blood sugar back up to safe levels. In type 1 diabetes, this glucagon backup system often stops working, leaving people vulnerable to sudden hypos.
Doctors are searching for treatments that can restore this natural glucagon response. Earlier research in laboratory settings and in type 2 diabetes suggests that two medicines—glibenclamide and dapagliflozin—might gently stimulate the cells that make glucagon. When used at very low doses, these drugs may help kick-start glucagon release without causing unwanted drops in blood sugar.
The LEGEND-D trial is testing whether this approach works in people living with type 1 diabetes. By comparing people who have type 1 diabetes with a comparison group of healthy volunteers, the study team hopes to understand the biology of hypos much better.
While this study is not guaranteed to change your personal treatment right away, its findings could open the door to brand-new treatments designed to protect people with type 1 diabetes from severe, frightening hypos in everyday life.
Wichtige Erkenntnisse
- Tests whether low doses of two existing medicines can help prevent hypos in type 1 diabetes.
- Open to adults aged 18 to 75 with type 1 diabetes, as well as healthy volunteers without diabetes.
- Involves hospital visits in Oxford with closely supervised, controlled blood sugar tests.
- Participants with diabetes receive detailed continuous glucose monitoring reports.
- Taking part is entirely voluntary, and you can withdraw at any time.
Wer könnte berechtigt sein?
This trial is open to adults aged 18 to 75. Researchers are looking for two groups of people: adults diagnosed with type 1 diabetes for at least one year, and healthy volunteers without diabetes to act as a comparison group.
To take part in the diabetes group, you should be using multiple daily injections or an insulin pump, and your recent long-term blood sugar level (HbA1c) must be below 10% (86 mmol/mol). You will also need to be familiar with managing hypos. You will not be able to join if you have had diabetic ketoacidosis (DKA) in the last month, more than one severe hypo needing emergency help in the past year, or active eye problems linked to diabetes.
For safety reasons, volunteers in both groups cannot take part if they have significant heart conditions, severe high blood pressure, kidney or liver problems, a history of seizures, or if they are pregnant or breastfeeding. Certain heart medications, such as beta-blockers, are also not permitted during the study.
Könnte diese Studie für Sie geeignet sein?
Beantworten Sie diese kurzen Fragen, um zu sehen, ob Sie möglicherweise berechtigt sind. Dies ist nur ein Leitfaden – das Forschungsteam trifft die endgültige Entscheidung.
- Sind Sie zwischen 18 und 75 Jahre alt?
- Have you had type 1 diabetes for at least 12 months, or do you have no history of diabetes?
- If you have diabetes, is your HbA1c below 10% (86 mmol/mol)?
- Are your heart, kidneys, and liver in generally good health?
- Sind Sie derzeit nicht schwanger oder stillen?
- Are you free from recent severe hypos or ketoacidosis in the past month?
Was beinhaltet die Teilnahme?
If you take part and have type 1 diabetes, your involvement will last around 8 to 10 weeks, split into four separate two-week blocks. You do not have to do these blocks back-to-back. During the study, you will take a liquid medicine called glibenclamide daily for up to 54 days, along with a single dose of dapagliflozin. You will also attend five closely monitored hospital tests where doctors gently lower your blood sugar in a safe, controlled way for 40 minutes to measure your hormone levels. You will wear a continuous glucose monitor (FreeStyle Libre) during the trial, and the team will give you reports showing your daily blood sugar patterns. Volunteers without diabetes will attend just one controlled test session without taking any ongoing medication.
Potenzielle Risiken und Vorteile
Standorte (1)
- Oxford Centre for Diabetes, Endocrinology and Metabolism (OCDEM)Nur StadtOxford, England
Häufige Fragen
Will taking part cure my type 1 diabetes?
No. The medicines being tested are not a cure. The researchers are studying whether they can help your body release glucagon to defend itself against low blood sugars.
Is the low blood sugar test safe?
Yes. While having a hypo feels unpleasant, the tests are done in a hospital under constant expert supervision. Your blood sugar is checked every five minutes, and staff can raise your levels back to normal instantly.
Do I have to stop taking my normal insulin?
No, you will continue your regular diabetes care alongside the study, although the research team will guide you on how to manage your insulin during the test visits.
Can I take part if I do not have diabetes?
Yes. The trial needs healthy adult volunteers without diabetes to act as a comparison group for a single test visit.
What happens if I change my mind after joining?
You are free to stop participating at any time. You do not need to give a reason, and your regular NHS medical care will not be affected in any way.
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