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

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What is this study about?

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.

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 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 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 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 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 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 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 Study?

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 Study?

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.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Steno Diabetes Center Copenhagen	Herlev	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Recruiting	01.09.2024

Trial locations

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.

Investigated diseases:

Hypoglycaemia

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 ID:

2023-509118-12-00

Trial Phase:

Therapeutic exploratory (Phase II)

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

What is this study about?

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