In short
This article provides information about 2 ongoing clinical trials investigating treatments for hypoglycaemia (low blood sugar). These trials are testing new therapies for people who experience severe low blood sugar episodes, including those with Type 1 Diabetes and those who have had weight-loss surgery.
Clinical trial locations
- Denmark
- France
- Germany
- Italy
- Netherlands
- Norway
Study on the Safety and Effectiveness of VX-880 for Patients with Type 1 Diabetes and Severe Low Blood Sugar Awareness
This trial is testing VX-880, an investigational cell therapy delivered through infusion, for people with Type 1 Diabetes who struggle to recognize when their blood sugar drops too low and experience severe episodes of low blood sugar.
Main inclusion criteria:
- Confirmed diagnosis of Type 1 Diabetes with laboratory evidence
- At least 2 episodes of severe low blood sugar in the past 12 months
- Reduced ability to recognize when blood sugar is getting too low
- Consistent use of a continuous glucose monitor for at least 3 months before the study (where commonly available)
- Blood type A or AB
- Both male and female participants within the specified age range are eligible
Main exclusion criteria:
- Other medical conditions besides Type 1 Diabetes that affect blood sugar levels and awareness of low blood sugar
- Being outside the study's age range
- Belonging to vulnerable populations not included in the study
Focus of the trial: The study aims to evaluate whether VX-880 is safe and effective in helping patients achieve insulin independence by one year after treatment. Participants receive a single infusion of VX-880 containing stem cell-derived islet cells. Researchers will monitor participants closely to track whether they can reduce or stop using insulin, experience fewer severe low blood sugar episodes, and improve their overall blood sugar control as measured by HbA1c levels. The trial includes long-term follow-up extending until December 2030 to assess lasting benefits.
Investigational drug: VX-880 is a cell therapy solution administered through infusion that aims to potentially restore insulin production in patients with Type 1 Diabetes who have impaired awareness of low blood sugar.
Study on Sotagliflozin for Treating Low Blood Sugar After Weight Loss Surgery in Patients with Post-Bariatric Hypoglycemia
This trial is investigating sotagliflozin, a medication taken as a daily tablet, for people who experience low blood sugar episodes after having Roux-en-Y gastric bypass surgery.
Main inclusion criteria:
- Age between 18 and 74 years
- Had Roux-en-Y gastric bypass surgery more than 18 months ago
- History of feeling unwell due to low blood sugar one to three hours after eating, which improves after eating carbohydrates
- Documented very low blood sugar episodes at least twice a week, confirmed by continuous glucose monitoring over 12-14 days
- Adequate hemoglobin levels (more than 7.3 mmol/l for women, more than 8.3 mmol/l for men)
- Fasting blood sugar level more than 3.5 mmol/l
- Normal heart rhythm with no history of heart rhythm problems or heart disease
- Negative pregnancy test for women who can have children
Main exclusion criteria:
- No history of Roux-en-Y gastric bypass surgery
- No confirmed diagnosis of post-bariatric low blood sugar
- Outside the specified age range
- Belonging to vulnerable populations
Focus of the trial: This is a crossover study where participants receive both sotagliflozin and placebo in random order, each for four weeks. The study is double-blind, meaning neither participants nor researchers know which treatment is being given at any time. Researchers will use continuous glucose monitors to track blood sugar levels throughout the study and assess whether sotagliflozin reduces the frequency and severity of low blood sugar episodes compared to placebo. Participants will also complete questionnaires about their symptoms and quality of life.
Investigational drug: Sotagliflozin is an oral medication belonging to a class of drugs called SGLT inhibitors. It works by inhibiting certain proteins in the kidneys and intestines to help regulate blood sugar levels. The study uses a 400 mg daily dose to investigate its effectiveness in managing low blood sugar after weight-loss surgery.
Summary
These 2 clinical trials represent different approaches to managing severe low blood sugar. One trial focuses on Type 1 Diabetes patients using an innovative cell therapy approach with VX-880, available across multiple European countries including the Netherlands, Norway, France, Germany, and Italy. The other trial investigates a medication-based approach with sotagliflozin for post-surgical low blood sugar complications, conducted in Denmark.
Both studies address serious complications of low blood sugar, but for different patient populations. The VX-880 trial targets long-term insulin independence and is following participants until 2030, while the sotagliflozin study uses a shorter crossover design to evaluate symptom management. Each trial employs continuous glucose monitoring to carefully track blood sugar levels and assess treatment effectiveness.
