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Study on Sotagliflozin for Treating Low Blood Sugar After Weight Loss Surgery in Patients with Post-Bariatric Hypoglycemia

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the effects of the medication sotagliflozin on a condition known as post-bariatric hypoglycemia. This condition can occur in individuals who have undergone a type of weight-loss surgery called Roux-en-Y gastric bypass (RYGB). After this surgery, some people experience episodes of low blood sugar, or hypoglycemia, which can happen after eating. The study aims to understand how sotagliflozin, a medication taken as a film-coated tablet, might help manage these low blood sugar episodes.

Participants in the study will receive two different treatments in a random order. One treatment involves taking sotagliflozin, and the other involves taking a placebo, which looks like the medication but does not contain the active ingredient. Each treatment period will last for four weeks. The study is designed to be double-blind, meaning neither the participants nor the researchers will know which treatment is being given at any time, to ensure unbiased results.

The purpose of the study is to investigate how sotagliflozin affects blood sugar levels and fluctuations in people who have had RYGB surgery and experience post-bariatric hypoglycemia. By comparing the effects of sotagliflozin with the placebo, researchers hope to determine if sotagliflozin can help reduce the frequency and severity of low blood sugar episodes in these individuals. The study will continue until March 2026, with recruitment expected to start in September 2024.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Introduction to the trial

    Upon joining the study, you will be introduced to the trial's purpose and procedures. This study is called the ONSIDE study and aims to investigate the effect of a medication called sotagliflozin on low blood sugar levels after bariatric surgery.

  2. Step 2

    Randomization

    You will be randomly assigned to receive either the medication sotagliflozin or a placebo for a period of four weeks. A placebo is a substance with no active medication, used to compare the effects of the actual medication.

  3. Step 3

    First treatment period

    During the first four-week period, you will take the assigned treatment once daily by mouth. If you are assigned to sotagliflozin, the dosage will be 400 mg per day.

  4. Step 4

    Crossover to second treatment

    After completing the first treatment period, you will switch to the other treatment for another four weeks. If you initially received sotagliflozin, you will now receive the placebo, and vice versa.

  5. Step 5

    Second treatment period

    During the second four-week period, you will continue to take the assigned treatment once daily by mouth. The dosage remains the same if you are taking sotagliflozin.

  6. Step 6

    Monitoring and assessments

    Throughout the study, your blood sugar levels will be monitored using a device called a continuous glucose monitor (CGM). This device tracks your blood sugar levels throughout the day and night.

    You will also be asked to complete questionnaires about your symptoms and quality of life.

  7. Step 7

    Completion of the trial

    At the end of the study, you will have a final assessment to review your experience and any changes in your condition. The information collected will help understand the effects of sotagliflozin on post-bariatric hypoglycemia.

Who can join the trial?

8 criteria

  • Age between 18 and 74 years old
  • Had a RYGB operation (a type of weight-loss surgery) more than 18 months ago
  • History of postprandial neuroglycopenia (feeling unwell due to low blood sugar one to three hours after eating, which gets better after eating carbohydrates)
  • Documented episodes of level 2 hypoglycaemia (very low blood sugar levels) at least twice a week, confirmed by a special device that measures sugar levels over 12-14 days
  • For women, haemoglobin levels (a measure of red blood cells) must be more than 7.3 mmol/l; for men, more than 8.3 mmol/l
  • Fasting plasma glucose concentration (blood sugar level after not eating) must be more than 3.5 mmol/l
  • Normal sinus rhythm (regular heartbeat) at screening and no history of heart rhythm problems or heart disease
  • Negative urine human chorionic gonadotropin (hCG) test for women who can have children (this is a pregnancy test)

Who cannot join the trial?

4 criteria

  • Patients who have not had a RYGB surgery (Roux-en-Y Gastric Bypass, a type of weight-loss surgery) cannot participate.
  • Patients who do not have confirmed post-bariatric hypoglycaemia (low blood sugar after weight-loss surgery) are excluded.
  • Patients who are not within the specified age range for the study cannot participate.
  • Patients who are part of a vulnerable population are not eligible.
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Investigated drugs

Sotagliflozin is a medication being studied for its potential to help manage low blood sugar levels in people who have undergone weight-loss surgery. This condition, known as post-bariatric hypoglycemia, can cause blood sugar levels to drop too low. Sotagliflozin works by helping the body control blood sugar levels, which may reduce the frequency and severity of these low blood sugar episodes. In this study, researchers are examining how effective sotagliflozin is in managing these symptoms compared to a placebo.

What is already known about the treatment

Sotagliflozin – Sotagliflozin is administered orally in the form of a tablet, taken once daily. It is currently being studied in clinical trials for its potential to treat post-bariatric hypoglycemia, a condition characterized by low blood sugar levels following weight-loss surgery. The medication works by inhibiting certain proteins in the kidneys and intestines, which helps to regulate blood sugar levels. Sotagliflozin belongs to a class of drugs known as SGLT inhibitors, which are typically used to manage blood sugar in people with diabetes.

Investigated diseases

Postbariatric hypoglycemia – Postbariatric hypoglycemia is a condition that occurs after bariatric surgery, such as Roux-en-Y gastric bypass. It is characterized by low blood sugar levels, known as hypoglycemia, which can happen after eating. This condition is due to changes in how the body processes glucose and insulin following surgery. Symptoms may include shakiness, sweating, confusion, and dizziness. The hypoglycemia typically occurs one to three hours after meals. Over time, the body may experience fluctuations in blood sugar levels, leading to episodes of both low and high blood sugar.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2023-509118-12-00Estimated enrolment24 patientsSponsorSteno Diabetes Center Copenhagen

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).