New Secondary Analysis of Phase 3 Data Demonstrates Sotagliflozin Improves Time-In-Range (TIR) and Several Parameters of Glucose Control and Variability in Basal Insulin-Treated Type 2 Diabetes
Lexicon Pharmaceuticals (Nasdaq: LXRX) announced positive results from the SOTA-INS CGM Phase 3 trial for sotagliflozin in type 2 diabetes (T2D) patients treated with basal insulin. The study showed that once-daily dosing of sotagliflozin 400 mg improved time-in-range (TIR) and several continuous glucose monitoring (CGM) parameters, including glucose variability. The 200 mg dose also showed positive trends.
Key findings include:
- Sotagliflozin 200 mg and 400 mg once daily TIR (15.3 and 15.9 hours, respectively) approached the American Diabetes Association's target of 17 hours
- Modest reductions in time-above-range (TAR) and mild increases in time-below-range (TBR) were observed
The results will be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) on September 12th, 2024.
Lexicon Pharmaceuticals (Nasdaq: LXRX) ha annunciato risultati positivi dallo studio SOTA-INS CGM di fase 3 per sotagliflozin in pazienti con diabete di tipo 2 (T2D) trattati con insulina basale. Lo studio ha dimostrato che la somministrazione giornaliera di 400 mg di sotagliflozin ha migliorato il tempo-in-range (TIR) e diversi parametri di monitoraggio continuo della glicemia (CGM), inclusa la variabilità glicemica. Anche la dose di 200 mg ha mostrato tendenze positive.
I risultati chiave includono:
- Il TIR della sotagliflozin a dosi di 200 mg e 400 mg una volta al giorno (rispettivamente 15,3 e 15,9 ore) si è avvicinato all'obiettivo di 17 ore dell'American Diabetes Association
- Si sono osservate riduzioni modeste del tempo sopra la soglia (TAR) e lievi aumenti del tempo sotto la soglia (TBR)
I risultati saranno presentati al 60° Congresso Annuale dell'Associazione Europea per lo Studio del Diabete (EASD) il 12 settembre 2024.
Lexicon Pharmaceuticals (Nasdaq: LXRX) anunció resultados positivos del ensayo SOTA-INS CGM de fase 3 para sotagliflozina en pacientes con diabetes tipo 2 (T2D) tratados con insulina basal. El estudio mostró que la dosis diaria única de 400 mg de sotagliflozina mejoró el tiempo en rango (TIR) y varios parámetros de monitoreo continuo de glucosa (CGM), incluida la variabilidad de la glucosa. La dosis de 200 mg también mostró tendencias positivas.
Los hallazgos clave incluyen:
- El TIR para sotagliflozina a dosis de 200 mg y 400 mg una vez al día (15.3 y 15.9 horas, respectivamente) se acercó al objetivo de 17 horas de la Asociación Americana de Diabetes
- Se observaron reducciones moderadas en el tiempo por encima del rango (TAR) y ligeros aumentos en el tiempo por debajo del rango (TBR)
Los resultados se presentarán en la 60ª Reunión Anual de la Asociación Europea para el Estudio de la Diabetes (EASD) el 12 de septiembre de 2024.
렉시콘 제약 (Nasdaq: LXRX)은 기초 인슐린으로 치료받는 제2형 당뇨병 (T2D) 환자에 대한 소타글리플로진의 SOTA-INS CGM 3상 시험에서 긍정적인 결과를 발표했습니다. 이 연구는 소타글리플로진 400mg의 하루 1회 투여가 혈당 범위 시간(TIR) 및 여러 연속 혈당 모니터링(CGM) 매개 변수를 개선했다는 것을 보여주었습니다. 200mg 용량도 긍정적인 경향을 보였습니다.
주요 결과는 다음과 같습니다:
- 소타글리플로진 200mg 및 400mg의 하루 1회 TIR (각각 15.3시간 및 15.9시간)은 미국당뇨병협회(ADA)의 17시간 목표에 접근했습니다.
- 상위 범위 시간(TAR)의 다소 감소와 하위 범위 시간(TBR)의 경미한 증가가 관찰되었습니다.
결과는 2024년 9월 12일 제60차 유럽당뇨병연구협회(EASD) 연례 회의에서 발표될 예정입니다.
Lexicon Pharmaceuticals (Nasdaq: LXRX) a annoncé des résultats positifs de l'essai SOTA-INS CGM de phase 3 pour sotagliflozine chez des patients atteints de diabète de type 2 (T2D) traités avec de l'insuline basale. L'étude a montré que l'administration quotidienne unique de 400 mg de sotagliflozine a amélioré le temps dans l'intervalle (TIR) et plusieurs paramètres de surveillance continue de la glycémie (CGM), y compris la variabilité de la glycémie. La dose de 200 mg a également montré des tendances positives.
Les résultats clés incluent :
- Le TIR pour la sotagliflozine à des doses de 200 mg et 400 mg une fois par jour (15,3 et 15,9 heures, respectivement) s'est approché de l'objectif de 17 heures de l'American Diabetes Association
- Des réductions modestes du temps au-dessus de la plage (TAR) et de légères augmentations du temps en dessous de la plage (TBR) ont été observées
Les résultats seront présentés lors de la 60ème Réunion Annuelle de l'Association Européenne pour l'Étude du Diabète (EASD) le 12 septembre 2024.
Lexicon Pharmaceuticals (Nasdaq: LXRX) gab positive Ergebnisse der SOTA-INS CGM Phase-3-Studie für Sotagliflozin bei Patienten mit Typ-2-Diabetes (T2D), die mit Basisinsulin behandelt wurden, bekannt. Die Studie ergab, dass die einmal tägliche Gabe von 400 mg Sotagliflozin die Zeit im Zielbereich (TIR) und mehrere Parameter der kontinuierlichen Glukoseüberwachung (CGM) verbesserte, einschließlich der Glukosevariabilität. Auch die 200 mg-Dosis zeigte positive Trends.
Wichtige Ergebnisse sind:
- Die TIR von Sotagliflozin in Dosen von 200 mg und 400 mg einmal täglich (15,3 bzw. 15,9 Stunden) näherte sich dem Ziel von 17 Stunden der American Diabetes Association
- Es wurden moderate Reduktionen der Zeit über dem Zielbereich (TAR) und leichte Erhöhungen der Zeit unter dem Zielbereich (TBR) beobachtet
Die Ergebnisse werden am 12. September 2024 auf der 60. Jahrestagung der Europäischen Diabetesgesellschaft (EASD) präsentiert.
- Sotagliflozin 400 mg improved time-in-range (TIR) and CGM parameters in T2D patients on basal insulin
- Both 200 mg and 400 mg doses approached ADA's TIR target of 17 hours
- Study results align with positive outcomes from previous T1D trials
- Data adds to evidence supporting the value of dual SGLT1 and SGLT2 inhibition
- Lexicon is not pursuing an indication to treat type 2 diabetes with sotagliflozin
- Mild increases in time-below-range (TBR) were observed
Insights
This new secondary analysis of Phase 3 data for sotagliflozin in type 2 diabetes (T2D) patients shows promising results. The study demonstrates improvements in Time-In-Range (TIR) and other glucose control parameters for patients treated with basal insulin. Key findings include:
- Sotagliflozin 400 mg once daily improved TIR and several CGM parameters, including glucose variability
- Positive trends were observed with the 200 mg dose as well
- TIR with sotagliflozin (15.3-15.9 hours) approached the ADA target of 17 hours
- Modest reductions in time-above-range (TAR) and mild increases in time-below-range (TBR) were noted
These results align with previous positive outcomes in type 1 diabetes trials, suggesting potential benefits across diabetes types. However, it's important to note that Lexicon is not pursuing a T2D indication for sotagliflozin, limiting its immediate market impact.
While the study results are positive, the financial implications for Lexicon Pharmaceuticals (LXRX) are Key points to consider:
- Lexicon is not pursuing a type 2 diabetes indication for sotagliflozin, restricting potential market expansion
- The data adds to the body of evidence supporting SGLT1 inhibition, which could indirectly benefit Lexicon's broader research efforts
- The presentation at EASD may increase visibility and scientific credibility for Lexicon's research
Investors should note that while these results are scientifically interesting, they are unlikely to have a significant direct impact on Lexicon's near-term financial performance or stock price. The company's focus remains on other indications and this study primarily serves to reinforce the potential of their dual SGLT1/2 inhibition approach.
Study results aligned with positive clinical trial outcomes for type 1 diabetes treatment with sotagliflozin
TIR measures approach target set by American Diabetes Association
Data to be presented at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online
THE WOODLANDS, Texas, Sept. 10, 2024 (GLOBE NEWSWIRE) -- Lexicon Pharmaceuticals, Inc. (Nasdaq: LXRX) today announced that data from the SOTA-INS CGM Phase 3 randomized clinical trial demonstrated that once-daily dosing of sotagliflozin 400 mg improved time-in-range (TIR) and several continuous glucose monitoring (CGM) parameters, including glucose variability, in insulin-treated type 2 diabetes (T2D) patients. Researchers also observed positive trends with the once-daily dose of 200 mg. Study findings will be presented September 12th at the 60th Annual Meeting of the European Association for the Study of Diabetes (EASD) in Madrid, Spain and online.
The objective of the SOTA-INS CGM study was to evaluate the effect of sotagliflozin on TIR as assessed by CGM in people with T2D. The primary sub-study endpoint was mean change in percentage of time spent within TIR (glucose 70-180 mg/dL [3.9-10.0 mmol/L]) over 24 hours for sotagliflozin 400 mg versus placebo.
The American Diabetes Association recommends a TIR target of at least
Sotagliflozin has previously demonstrated glycemic efficacy and improvements in TIR as an adjunct to insulin therapy in people with T1D who participated in the inTandem clinical trial program.
Details of the data presentation are as follows:
- Effect of Sotagliflozin, a Dual SGLT 1 and 2 Inhibitor, on Continuous Glucose Monitoring in Basal Insulin-Treated Type 2 Diabetes – an ePoster presentation, Thursday, September 12th, 12:45p.m. CEST, IFEMA Madrid, Station 10 and online, presented by Julio Rosenstock, M.D., Senior Scientific Advisor for Velocity Clinical Research, Director of Velocity’s site at Medical City Dallas, and Clinical Professor of Medicine at the University of Texas Southwestern Medical Center, Dallas.
“We are encouraged by the observation of Dr. Rosenstock and his fellow researchers that sotagliflozin’s dual inhibition of SGLT2 and SGLT1 may offer an additional therapeutic option to improve glycemic control for people with type 2 diabetes on basal insulin,” said Craig Granowitz, M.D., Ph.D., Lexicon’s senior vice president and chief medical officer. “While we are not pursuing an indication to treat people with type 2 diabetes, this study adds to the body of evidence supporting the incremental value of inhibiting SGLT1.”
About sotagliflozin
Discovered using Lexicon’s unique approach to gene science, sotagliflozin is an oral inhibitor of two proteins responsible for glucose regulation known as sodium-glucose cotransporter types 2 and 1 (SGLT2 and SGLT1). SGLT2 is responsible for glucose and sodium reabsorption by the kidney and SGLT1 is responsible for glucose and sodium absorption in the gastrointestinal tract. Sotagliflozin has been studied in multiple patient populations encompassing heart failure, diabetes, and chronic kidney disease in clinical studies involving approximately 20,000 patients.
About Lexicon Pharmaceuticals
Lexicon is a biopharmaceutical company with a mission of pioneering medicines that transform patients’ lives. Through the Genome5000™ program, Lexicon’s unique genomics target discovery platform, Lexicon scientists studied the role and function of nearly 5,000 genes and identified more than 100 protein targets with significant therapeutic potential in a range of diseases. Through the precise targeting of these proteins, Lexicon is pioneering the discovery and development of innovative medicines to treat disease safely and effectively. Lexicon has commercially launched one of these medicines, INPEFA® (sotagliflozin) in the United States, and has a pipeline of other promising drug candidates in discovery and clinical and preclinical development in neuropathic pain, diabetes and metabolism and other indications. For additional information, please visit www.lexpharma.com.
Safe Harbor Statement
This press release contains “forward-looking statements,” including statements relating to Lexicon’s financial position and long-term outlook on its business, including the commercialization of its approved products and the clinical development of, regulatory filings for, and potential therapeutic and commercial potential of its other drug candidates. In addition, this press release also contains forward looking statements relating to Lexicon’s growth and future operating results, discovery, development and commercialization of products, strategic alliances and intellectual property, as well as other matters that are not historical facts or information. All forward-looking statements are based on management’s current assumptions and expectations and involve risks, uncertainties and other important factors, specifically including Lexicon’s ability to meet its capital requirements, successfully commercialize its approved products, successfully conduct preclinical and clinical development and obtain necessary regulatory approvals of its other drug candidates on its anticipated timelines, achieve its operational objectives, obtain patent protection for its discoveries and establish strategic alliances, as well as additional factors relating to manufacturing, intellectual property rights, and the therapeutic or commercial value of its approved products and other drug candidates. Any of these risks, uncertainties and other factors may cause Lexicon’s actual results to be materially different from any future results expressed or implied by such forward-looking statements. Information identifying such important factors is contained under “Risk Factors” in Lexicon’s annual report on Form 10-K for the year ended December 31, 2023, as filed with the Securities and Exchange Commission. Lexicon undertakes no obligation to update or revise any such forward-looking statements, whether as a result of new information, future events or otherwise.
For Investor and Media Inquiries:
Lisa DeFrancesco
Lexicon Pharmaceuticals, Inc.
lexinvest@lexpharma.com
FAQ
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