Publications by authors named "Sangeeta Sawhney"
Background & Aims: Fibrosis stage is a strong predictor of nonalcoholic steatohepatitis (NASH) outcomes. Two blinded studies evaluated the pharmacokinetics, pharmacodynamics and safety of obeticholic acid (OCA) in subjects with staged NASH fibrosis or cirrhosis.
Methods: Study 747-117 randomized 51 subjects with NASH (fibrosis stages F1-F4) to daily placebo, OCA 10 or OCA 25 mg (1:2:2) for 85 days.
Background: Liver histopathologic assessment is the accepted surrogate endpoint in NASH trials; however, the scoring of NASH Clinical Research Network (CRN) histologic parameters is limited by intraobserver and interobserver variability. We designed a consensus panel approach to minimize variability when using this scoring system. We assessed agreement between readers, estimated linear weighted kappas between 2 panels, compared them with published pairwise kappa estimates, and addressed how agreement or disagreement might impact the precision and validity of the surrogate efficacy endpoint in NASH trials.
View Article and Find Full Text PDFBackground & Aims: Obeticholic acid (OCA) is a first-in-class farnesoid X receptor agonist and antifibrotic agent in development for the treatment of pre-cirrhotic liver fibrosis due to non-alcoholic steatohepatitis (NASH). We aimed to validate the original 18-month liver biopsy analysis from the phase III REGENERATE trial of OCA for the treatment of NASH with a consensus panel analysis, provide additional histology data in a larger population, and evaluate safety from >8,000 total patient-years' exposure with nearly 1,000 participants receiving study drug for >4 years.
Methods: Digitized whole-slide images were evaluated independently by panels of three pathologists using the NASH Clinical Research Network scoring system.
Article Synopsis
- The study aimed to assess how sotagliflozin, a medication for type 1 diabetes (T1D), impacts arterial stiffness in patients already using insulin therapy.
- Researchers analyzed data from trials involving 1,575 participants, focusing on indirect indicators of arterial stiffness like blood pressure measurements.
- Results indicated that sotagliflozin significantly reduced systolic and diastolic blood pressure along with other stiffness markers, demonstrating its potential benefits for vascular health in T1D patients without raising heart rates.
Efficacy and safety of adding sotagliflozin, a dual sodium-glucose co-transporter (SGLT)1 and SGLT2 inhibitor, to optimized insulin therapy in adults with type 1 diabetes and baseline body mass index ≥ 27 kg/m.
Thomas Danne Steven Edelman Juan Pablo Frias Francisco Javier Ampudia-Blasco Philip Banks Sangeeta Sawhney
Diabetes Obes Metab
March 2021
Article Synopsis
- Sotagliflozin is a medication approved in Europe for adults with type 1 diabetes (T1D) who have a BMI of 27 kg/m² or higher, used alongside insulin treatment.
- In a post hoc analysis of phase 3 trials, patients taking sotagliflozin experienced significant reductions in blood sugar levels, body weight, and systolic blood pressure compared to placebo, particularly benefiting those with higher BMI.
- While the drug was associated with fewer severe hypoglycemia events, there was an increased incidence of diabetic ketoacidosis, suggesting it may help improve glycemic control without raising the risk of low blood sugar in overweight or obese T1D patients.
Article Synopsis
- The study aimed to evaluate the occurrence and risk factors of diabetic ketoacidosis (DKA) in adults with type 1 diabetes who were treated with sotagliflozin alongside insulin.
- During the research, 191 ketosis-related adverse events were reported, with 37 adjudicated as DKA, showing a higher DKA incidence for patients taking sotagliflozin compared to those on placebo.
- After a risk mitigation plan was implemented, the incidence of DKA decreased in patients taking sotagliflozin, indicating that patient education can help manage this risk.
Article Synopsis
- Diabetes-related distress is prevalent among individuals with diabetes and negatively impacts both glycemic control and overall health, making it an important patient-reported outcome (PRO).
- A study analyzing data from adults with type 1 diabetes (T1D) using sotagliflozin alongside insulin found that a higher percentage of patients reported significant improvements in treatment satisfaction compared to those on placebo.
- Overall, patients taking sotagliflozin experienced notable reductions in both diabetes distress and improvements in treatment satisfaction, highlighting its potential benefits in diabetes management.
Article Synopsis
- Young adults with type 1 diabetes (T1D) often have higher A1C levels and face greater risks of diabetic ketoacidosis (DKA), prompting a study to explore the use of sotagliflozin, an oral adjunct to insulin, in this population.
- In a 12-week study, participants aged 18-30 with A1C levels of 9.0% or higher were given either sotagliflozin or a placebo alongside insulin; results indicated that sotagliflozin led to greater decreases in A1C levels and improved postprandial glucose and weight compared to the placebo.
- The findings showed that more patients taking sotagliflozin achieved an A1C
Article Synopsis
- Hypoglycemia (low blood sugar) rates tend to rise with increased insulin treatment, but this study evaluated the effects of sotagliflozin, a medication for type 1 diabetes, on hypoglycemic rates over 52 weeks.
- The analysis involved 1,362 adults comparing rates of mild (level 1) and serious (level 2) hypoglycemia between those on placebo and two doses of sotagliflozin.
- Results showed that patients on sotagliflozin experienced 22% to 30% fewer hypoglycemia events compared to placebo, especially notable at lower blood sugar levels, indicating its potential as an effective adjunct therapy for insulin treatment in type 1 diabetes.
Article Synopsis
- This study evaluated the effects of sotagliflozin, a medication, on adults with type 1 diabetes over 12 weeks in a double-blind trial comparing different doses to a placebo.
- The results showed that sotagliflozin helped reduce glycated hemoglobin (HbA1c), particularly at the 200 mg and 400 mg doses, and led to a reduction in weight and increased glucose excretion.
- Overall, the medication improved glycemic control without significantly increasing the risk of severe low blood sugar or diabetic ketoacidosis, indicating it could be a beneficial addition to insulin therapy for type 1 diabetes patients.
Article Synopsis
- The study investigates the effects of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, in adults with type 1 diabetes when used alongside insulin, focusing on improved glucose time in range (TIR) and other glycemic metrics.
- Data from two randomized, double-blind clinical trials were pooled, comparing the effects of different doses of sotagliflozin (200 mg and 400 mg) with a placebo on glucose levels over 24 weeks using continuous glucose monitoring.
- Results showed that both doses of sotagliflozin significantly improved glucose TIR and reduced postprandial glucose levels without increasing the risk of hypoglycemia, demonstrating better glycemic control in participants.
Article Synopsis
- The study aimed to assess the safety and effectiveness of sotagliflozin, a dual sodium-glucose cotransporter inhibitor, in adult T1D patients when combined with optimized insulin treatment compared to a placebo.
- Conducted over 52 weeks, the trial involved randomizing adults with T1D into three groups: placebo, 200 mg, and 400 mg of sotagliflozin, with the main focus on changes in HbA levels at 24 weeks.
- Results showed that sotagliflozin significantly reduced HbA levels, improved glycemic control, lowered weight and insulin doses, and decreased the incidence of severe hypoglycemia, along with positive treatment satisfaction outcomes, especially in the
Article Synopsis
- The inTandem1 trial tested the effectiveness and safety of sotagliflozin, a dual SGLT1 and SGLT2 inhibitor, in adults with type 1 diabetes (T1D) alongside optimized insulin therapy over 52 weeks.
- Results showed that patients taking sotagliflozin experienced significant reductions in HbA1c levels, weight loss, and lower insulin doses compared to those on placebo, with 40.3% reaching an HbA1c target of less than 7% at 24 weeks.
- While sotagliflozin showed positive outcomes, it was associated with a higher incidence of adverse effects like genital infections and diabetic ketoacidosis, but overall, patients reported