Table of contents
- Trials at a glance
- Type 1 diabetes and cardiovascular risk
- Post-bariatric hypoglycaemia
- Kidney complications in type 1 diabetes
- Hypertrophic cardiomyopathy
- Study designs and endpoints
- Who the studies are for
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.[1][2][3][4]
The trials are authorised and include both Phase 2 and Phase 3 studies.[1][2][3][4]
The studies are interventional, which means participants receive a study treatment and outcomes are measured over time.[1][2][3][4]
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.[1]
This study is large, with an enrollment of 2050 people, and it compares a multifactorial intervention strategy with standard care.[1]
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.[1]
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.[1]
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.[2]
This study includes 24 participants and uses a randomized, double-blind, placebo-controlled crossover design.[2]
Participants are people who had Roux-en-Y gastric bypass surgery and have confirmed biochemical post-bariatric hypoglycaemia.[2]
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.[2]
Participants receive Sotagliflozin 400 mg once daily and placebo in random order for four weeks each.[2]
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.[3]
It has an enrollment of 69 participants and compares Sotagliflozin with a matching placebo product.[3]
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.[3]
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.[3]
Hypertrophic cardiomyopathy
Another Phase 3 trial is studying whether Sotagliflozin improves symptoms and is safe in people with hypertrophic cardiomyopathy.[4]
The listed condition names include obstructive cardiomyopathy, hypertrophic, and non-obstructive hypertrophic cardiomyopathy.[4]
This study plans to enroll 500 participants and compares Sotagliflozin with placebo.[4]
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.[4]
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.[1][2][3][4]
Endpoints, which are the main results the study wants to measure, are different in each trial and match the condition being studied.[1][2][3][4]
- Cardiovascular outcomes: the type 1 diabetes study measures serious heart and blood vessel events, including heart attack, stroke, cardiovascular death, and heart failure hospitalization.[1]
- Low blood sugar time: the post-bariatric hypoglycaemia study measures how much time people spend with very low glucose levels.[2]
- Kidney oxygenation: the kidney study uses MRI-based signals to estimate how well the kidney is oxygenated.[3]
- Symptom score: the cardiomyopathy study uses a questionnaire score to track symptoms and daily function.[4]
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.[1][2][3][4]
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.[1][2][3][4]
In simple terms, the research is trying to learn where Sotagliflozin may help most, and what outcomes should be measured in each disease area.[1][2][3][4]
