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Sotagliflozin for the treatment of post-bariatric hypoglycaemia: The ONSIDE study
EU CTIS ID: 2023-509118-12-00
What this study is testing
We aim to investigate the effect of sotagliflozin on hypoglycaemia and glycaemic excursions in an interventional randomized, double-blind, placebo-controlled crossover study in RYGB-operated persons suffering from confirmed biochemical post-bariatric hypoglycaemia. Participants will undergo the following two interventions in random order for periods of four weeks: sotagliflozin 400 mg QD and placebo.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age 18-74 years
- RYGB-operation conducted >18 months ago
- History of postprandial neuroglycopenia one–to–three hours after meal intake with subsequent relief after carbohydrate ingestion (per interview)
- Documented postprandial episodes of level 2 hypoglycaemia (interstitial glucose concentration (IG) <3.0 mmol/l for ≥15 min, ≥2 times/week) assessed by 12-14 days of blinded CGM recording
- Haemoglobin levels for women >7.3 mmol/l and for men > 8.3 mmol/l
- Fasting plasma glucose concentration >3.5 mmol/l
You likely can't join if
- Treatment with medication(s) affecting insulin secretion, glucose metabolism, or any antidiabetic drugs
- History of hypersensitivity or allergic reaction to sotagliflozin or any of the excipients
- Known or suspected allergies to SGLT-2 inhibitors or related products
- History of ketoacidosis
- History of chronic kidney disease or an estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2
- Current participation in another clinical trial with administration of an investigational drug
See the full eligibility criteria
- Age 18-74 years
- RYGB-operation conducted >18 months ago
- History of postprandial neuroglycopenia one–to–three hours after meal intake with subsequent relief after carbohydrate ingestion (per interview)
- Documented postprandial episodes of level 2 hypoglycaemia (interstitial glucose concentration (IG) <3.0 mmol/l for ≥15 min, ≥2 times/week) assessed by 12-14 days of blinded CGM recording
- Haemoglobin levels for women >7.3 mmol/l and for men > 8.3 mmol/l
- Fasting plasma glucose concentration >3.5 mmol/l
- Sinus rhythm at screening and no medical history of cardiac arrhythmias or cardiac ischaemia
- Negative urine human chorionic gonadotropin (hCG) (for fertile women)
- Treatment with medication(s) affecting insulin secretion, glucose metabolism, or any antidiabetic drugs
- History of hypersensitivity or allergic reaction to sotagliflozin or any of the excipients
- Known or suspected allergies to SGLT-2 inhibitors or related products
- History of ketoacidosis
- History of chronic kidney disease or an estimated glomerular filtration rate (eGFR) <60 ml/min/1.73 m2
- Current participation in another clinical trial with administration of an investigational drug
- Pregnancy or breastfeeding
- Glycated haemoglobin (HbA1c) ≥48 mmol/mol
- Major surgery within 30 days before screening
- Alcohol abuse (per investigator assessment)
- Any factors that, in the opinion of the site principal investigator or clinical protocol chair, would interfere with the safe completion of the study, including medical conditions that may require hospitalization during the trial
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.