In short
Clinical trials are investigating Sotagliflozin in different patient groups, including people with type 1 diabetes, post-bariatric hypoglycaemia, chronic kidney complications, and hypertrophic cardiomyopathy. These studies are mainly looking at safety, symptom changes, and measures of disease control. The trials include Phase 2 and Phase 3 research.
Key points
- Sotagliflozin is being studied in several different clinical trials, mainly in people with type 1 diabetes, post-bariatric hypoglycaemia, chronic kidney complications, and hypertrophic cardiomyopathy. The studies include both Phase 2 and Phase 3 trials. Some trials compare Sotagliflozin with placebo, while others look at broader care strategies or symptom changes. The main outcomes include cardiovascular events, low blood sugar time, kidney oxygenation, and heart-related symptom scores. The trial populations are specific, such as people with confirmed post-bariatric hypoglycaemia or symptomatic hypertrophic cardiomyopathy.
Trials at a glance
Clinical trials of Sotagliflozin in the source data are being done in four main patient groups: people with type 1 diabetes, people with post-bariatric hypoglycaemia, people with chronic kidney complications linked to type 1 diabetes, and people with hypertrophic cardiomyopathy.
The trials are authorised and include both Phase 2 and Phase 3 studies.
The studies are interventional, which means participants receive a study treatment and outcomes are measured over time.
Type 1 diabetes and cardiovascular risk
One Phase 3 trial is studying a strategy of intensified care in people with type 1 diabetes who are at high risk of cardiovascular disease.
This study is large, with an enrollment of 2050 people, and it compares a multifactorial intervention strategy with standard care.
The main outcome is time to the first major adverse cardiovascular event (MACE), which includes non-fatal heart attack, non-fatal stroke, cardiovascular death, or first hospitalization for heart failure.
The trial also includes safety and efficacy evaluation of 40 mg finerenone in people with type 1 diabetes who are at risk of cardiovascular death and hospitalization for heart failure, but Sotagliflozin is listed among the study interventions in this trial record.
Post-bariatric hypoglycaemia
The ONSIDE study is a Phase 2 trial of Sotagliflozin for post-bariatric hypoglycaemia, which means low blood sugar that happens after bariatric surgery.
This study includes 24 participants and uses a randomized, double-blind, placebo-controlled crossover design.
Participants are people who had Roux-en-Y gastric bypass surgery and have confirmed biochemical post-bariatric hypoglycaemia.
The main outcome is time spent in level 2 hypoglycaemia, defined in the source as glucose below 3.0 mmol/L, measured by continuous glucose monitoring during the outpatient part of the study.
Participants receive Sotagliflozin 400 mg once daily and placebo in random order for four weeks each.
Kidney complications in type 1 diabetes
The PLUTO study is a Phase 2 trial in people with Type 1 Diabetes Mellitus with chronic kidney complications.
It has an enrollment of 69 participants and compares Sotagliflozin with a matching placebo product.
The main outcome is the change from baseline to 12 weeks in a dynamic R2*-weighted signal on BOLD MRI, which is used as an indirect measure of renal blood oxygenation.
The brief summary says the study aims to estimate the effect of three months of Sotagliflozin on renal oxygenation in people with type 1 diabetes and chronic kidney disease.
Hypertrophic cardiomyopathy
Another Phase 3 trial is studying whether Sotagliflozin improves symptoms and is safe in people with hypertrophic cardiomyopathy.
The listed condition names include obstructive cardiomyopathy, hypertrophic, and non-obstructive hypertrophic cardiomyopathy.
This study plans to enroll 500 participants and compares Sotagliflozin with placebo.
The primary outcome is the change from baseline to week 26 in the Kansas City Cardiomyopathy Questionnaire Clinical Summary Score, which measures symptoms and functional limitations.
Study designs and endpoints
Across the trial records, the main study designs include placebo comparison, crossover treatment, and large Phase 3 testing against standard care or placebo.
Endpoints, which are the main results the study wants to measure, are different in each trial and match the condition being studied.
- Cardiovascular outcomes: the type 1 diabetes study measures serious heart and blood vessel events, including heart attack, stroke, cardiovascular death, and heart failure hospitalization.
- Low blood sugar time: the post-bariatric hypoglycaemia study measures how much time people spend with very low glucose levels.
- Kidney oxygenation: the kidney study uses MRI-based signals to estimate how well the kidney is oxygenated.
- Symptom score: the cardiomyopathy study uses a questionnaire score to track symptoms and daily function.
Who the studies are for
These trials are not for the general public; each one is aimed at a specific patient group described in the source data.
People in the studies may have type 1 diabetes with high cardiovascular risk, confirmed post-bariatric hypoglycaemia after Roux-en-Y gastric bypass, chronic kidney disease linked to type 1 diabetes, or symptomatic hypertrophic cardiomyopathy.
In simple terms, the research is trying to learn where Sotagliflozin may help most, and what outcomes should be measured in each disease area.