What Is Sotagliflozin?
Sotagliflozin is an FDA-approved medication that functions as a dual sodium-glucose cotransporter 1 (SGLT1) and sodium-glucose cotransporter 2 (SGLT2) inhibitor. It works by blocking these proteins, which are responsible for reabsorbing glucose in the kidneys and intestines. By inhibiting SGLT1 and SGLT2, sotagliflozin helps the body remove excess glucose through urine and may also reduce glucose absorption from the digestive tract.
This medication is approved for certain conditions, and it is also being investigated in clinical trials for a range of uses. These include managing blood sugar levels in people with diabetes, as well as exploring its potential benefits for heart and kidney health. Clinical studies are also examining its effects on platelet activation and myocardial glucose suppression.
Uses and Conditions Under Study
Sotagliflozin is primarily studied for its role in managing diabetes. This includes Type 2 Diabetes Mellitus (19 trials), Type 1 Diabetes Mellitus (7 trials), and general Diabetes Mellitus (6 trials), along with specific studies for Type 1 Diabetes (5 trials) and Type 2 Diabetes (2 trials). As an SGLT1/2 inhibitor, sotagliflozin helps lower blood glucose by promoting its excretion through urine and reducing intestinal absorption, which is beneficial for people with both types of diabetes who often struggle to achieve optimal glycemic control.
The drug is also being investigated for its potential benefits in heart and kidney conditions. Heart Failure is being studied in 5 trials, while Chronic Kidney Disease and Diabetic Nephropathies are each being explored in 2 trials. Medications in this class have shown promise in protecting the heart and kidneys, particularly in patients with diabetes, by reducing the risk of complications like end-stage kidney disease.
Additionally, sotagliflozin is being studied in Healthy Subjects (3 trials) and Healthy individuals (3 trials). These studies typically aim to understand how the drug is absorbed, distributed, metabolized, and excreted in the body, as well as to assess its safety profile before it is widely used in patients with specific conditions.
Dosing
Sotagliflozin has been studied in various dosage forms, including oral tablets and an oral solution. The strengths investigated range from 10 mg to 400 mg. Common doses include 200 mg and 400 mg, typically taken once daily.
For instance, some trials initiated treatment with 200 mg of sotagliflozin once daily for 6 weeks. In other studies, patients began with 200 mg daily, with the option to increase to 400 mg daily if glycemic control targets were not met and kidney function allowed. A 400 mg dose has also been studied prior to anthracycline infusions. Other strengths, such as 75 mg and a range of 10-40 mg daily, have also been explored in clinical research. The specific dose and duration of treatment depend on the condition being studied and the individual's response to the medication.
Side Effects
In clinical trials, the most commonly reported side effect for patients taking Sotagliflozin was viral upper respiratory tract infection. In one study involving 524 patients, 17.7% of those on Sotagliflozin experienced this, compared to 15.5% on placebo.
Other common side effects reported in studies comparing Sotagliflozin to placebo include:
- Diarrhea: 6.5% of patients taking Sotagliflozin experienced diarrhea, compared to 4.5% on placebo.
- Hypoglycaemia (low blood sugar): 7.2% of patients on Sotagliflozin experienced hypoglycemia, compared to 7.5% on placebo.
- Upper respiratory tract infection: 6.7% of patients on Sotagliflozin experienced this, compared to 9.7% on placebo.
- Nausea: 6.5% of patients on Sotagliflozin experienced nausea, compared to 6.6% on placebo.
- Urinary tract infection: 6.0% of patients on Sotagliflozin experienced a urinary tract infection, compared to 6.4% on placebo.
- Vulvovaginal mycotic infection (a type of yeast infection): 3.9% of patients on Sotagliflozin experienced this, compared to 1.5% on placebo.
These side effects were observed across various clinical trials involving thousands of patients.
Clinical Trial Results
Clinical trials have investigated the efficacy of Sotagliflozin as an add-on therapy for adults and young adults with inadequately controlled Type 1 Diabetes Mellitus.
Study NCT01742208: Patients with Inadequately Controlled Type 1 Diabetes Mellitus
In this study, Sotagliflozin significantly improved several measures of glucose control. Patients receiving Sotagliflozin 400 mg in one group experienced an average reduction in fasting plasma glucose (FPG) of 54.2 mg/dL, while the placebo group saw an increase of 10.0 mg/dL. Sotagliflozin also increased the time patients spent in the healthy euglycemic range (blood sugar between 70 and 180 mg/dL) by up to 11.1%, compared to a 1.2% decrease for placebo. Additionally, patients on Sotagliflozin 400 mg were able to reduce their total daily insulin requirements by up to 27.00%, whereas the placebo group had a 1.20% decrease.
Study NCT02383940: Young Adult Patients with Type 1 Diabetes Mellitus and Elevated A1C
This trial focused on young adults. After 12 weeks, patients on Sotagliflozin 400 mg saw their 2-hour postprandial glucose (blood sugar after a meal) decrease by 56.4 mg/dL, while the placebo group had a slight increase of 0.2 mg/dL. Hemoglobin A1C (a measure of average blood sugar over 2-3 months) also showed a greater reduction with Sotagliflozin, decreasing by 1.33% compared to a 0.99% decrease with placebo. Patients on Sotagliflozin 400 mg also reduced their daily bolus insulin dose by 4.89 IU/day, while the placebo group increased theirs by 3.26 IU/day.
Studies NCT02384941 and NCT02421510: Adjunct Therapy in Adults with Inadequate Glycemic Control
These trials demonstrated that Sotagliflozin, when added to insulin therapy, helped patients achieve better glycemic control and manage weight. In study NCT02384941, patients taking Sotagliflozin 400 mg experienced an average weight reduction of 2.67 kg, compared to a 0.78 kg increase in the placebo group. A significant finding was the percentage of patients who reached an A1C below 7.0% without severe hypoglycemia or diabetic ketoacidosis (DKA): 43.5% of patients on Sotagliflozin 400 mg achieved this, compared to 21.6% on placebo. Similarly, in study NCT02421510, 32.3% of patients on Sotagliflozin 400 mg reached this target, compared to 15.1% on placebo. Both studies also showed reductions in A1C and fasting plasma glucose with Sotagliflozin.
Study NCT024598
Currently Recruiting Trials
Sotagliflozin is currently being investigated in several clinical trials across different conditions, exploring its potential benefits for patients. These studies aim to understand how this medication might improve health outcomes, from managing heart conditions to protecting kidney function. One early-phase study, NCT06933056, sponsored by the University of Michigan, is comparing the antiplatelet effects of sotagliflozin to other FDA-approved antiplatelet drugs. This trial, enrolling 20 healthy subjects, seeks to identify potential benefits in regulating platelet activation. For individuals with Type 1 Diabetes and heart failure symptoms, the University of Dundee is sponsoring a Phase 2 trial, NCT06435156. This study aims to enroll 320 participants to investigate if sotagliflozin can alleviate symptoms like breathlessness and ankle swelling. The University of Pennsylvania is conducting an early-phase study, NCT06433050, involving 26 adult patients with symptomatic, nonobstructive hypertrophic cardiomyopathy. This trial will assess the safety and effectiveness of sotagliflozin in this specific heart condition. Another University of Pennsylvania study, NCT06510894, is a pilot mechanistic study enrolling 40 participants with cardiac sarcoidosis, investigating how sotagliflozin might improve myocardial glucose suppression for diagnostic purposes. For patients with Type 1 Diabetes and diabetic kidney disease, a Phase 3 study, NCT06217302, is recruiting 150 participants to determine if sotagliflozin can slow the decline of kidney function. Lexicon Pharmaceuticals is sponsoring a larger Phase 3 trial, NCT06481891, enrolling 500 participants with symptomatic obstructive and non-obstructive hypertrophic cardiomyopathy to evaluate changes in symptoms and functional limitations. The University of California, San Diego, is conducting a Phase 1/Phase 2 crossover trial, NCT05696366, for 24 participants with Type 1 Diabetes, exploring a combination adjunctive therapy including sotagliflozin. Finally, the Steno Diabetes Center Copenhagen is leading a substantial Phase 3 study, NCT06082063, aiming to enroll 2000 individuals with Type 1 Diabetes at high risk of cardiovascular disease, testing a multifactorial intervention that includes sotagliflozin.Where to Participate
Sotagliflozin clinical trials are currently recruiting across a wide geographic area, offering many opportunities for participation. These studies are active at 49 sites in 39 cities across 24 states within the United States. Some of the top locations with multiple recruiting sites include:- Philadelphia, Pennsylvania (3 sites)
- Boston, Massachusetts (3 sites)
- Seattle, Washington (3 sites)
- Cleveland, Ohio (2 sites)
- Ann Arbor, Michigan (2 sites)
- St Louis, Missouri (2 sites)
- Orlando, Florida (2 sites)
- Portland, Oregon (2 sites)
- Jacksonville, Florida (1 site)
- Atlanta, Georgia (1 site)