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Last Updated: February 7, 2025

CLINICAL TRIALS PROFILE FOR SOTAGLIFLOZIN


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All Clinical Trials for Sotagliflozin

Trial ID Title Status Sponsor Phase Start Date Summary
NCT01742208 ↗ Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus Completed Sanofi Phase 2 2013-02-01 This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).
NCT01742208 ↗ Safety and Efficacy of Sotagliflozin (LX4211) in Patients With Inadequately Controlled Type 1 Diabetes Mellitus Completed Lexicon Pharmaceuticals Phase 2 2013-02-01 This Phase 2 study was intended to assess the pharmacodynamics (PD), pharmacokinetics (PK), safety and efficacy of sotagliflozin following daily oral administration for 29 days in participants with type 1 diabetes mellitus (T1DM).
NCT02383940 ↗ Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C Completed Juvenile Diabetes Research Foundation Phase 2 2015-04-01 This Phase 2 study was intended to demonstrate superiority of sotagliflozin versus placebo on Hemoglobin A1C (A1C) reduction at Week 12 in young adult participants with type 1 diabetes mellitus (T1DM) who have poor glycemic control on their current insulin regimen.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Sotagliflozin

Condition Name

Condition Name for Sotagliflozin
Intervention Trials
Type 2 Diabetes Mellitus 19
Type 1 Diabetes Mellitus 7
Diabetes Mellitus 6
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Condition MeSH

Condition MeSH for Sotagliflozin
Intervention Trials
Diabetes Mellitus 36
Diabetes Mellitus, Type 2 19
Diabetes Mellitus, Type 1 12
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Clinical Trial Locations for Sotagliflozin

Trials by Country

Trials by Country for Sotagliflozin
Location Trials
United States 327
Canada 21
Germany 12
United Kingdom 11
Hungary 10
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Trials by US State

Trials by US State for Sotagliflozin
Location Trials
Texas 20
Florida 18
California 16
North Carolina 16
Louisiana 12
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Clinical Trial Progress for Sotagliflozin

Clinical Trial Phase

Clinical Trial Phase for Sotagliflozin
Clinical Trial Phase Trials
Phase 4 3
Phase 3 17
Phase 2/Phase 3 1
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Clinical Trial Status

Clinical Trial Status for Sotagliflozin
Clinical Trial Phase Trials
Completed 28
Terminated 6
Not yet recruiting 6
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Clinical Trial Sponsors for Sotagliflozin

Sponsor Name

Sponsor Name for Sotagliflozin
Sponsor Trials
Sanofi 43
Lexicon Pharmaceuticals 22
Juvenile Diabetes Research Foundation 4
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Sponsor Type

Sponsor Type for Sotagliflozin
Sponsor Trials
Industry 65
Other 31
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Sotagliflozin: Clinical Trials Update, Market Analysis, and Projections

Introduction to Sotagliflozin

Sotagliflozin is a dual sodium-glucose cotransporter (SGLT) 1 and 2 inhibitor, developed by Lexicon Pharmaceuticals, with promising indications for treating various cardiovascular and renal conditions associated with type 2 diabetes mellitus (T2DM) and chronic kidney disease (CKD).

Clinical Trials Overview

SOLOIST and SOLOIST-WHF Trials

The SOLOIST and SOLOIST-WHF trials are pivotal in understanding the efficacy and safety of sotagliflozin. These phase 3, placebo-controlled, double-blind trials were designed to evaluate the drug's ability to reduce cardiovascular (CV) events in patients with heart failure (HF) and T2DM.

  • SOLOIST Trial: This trial randomized 1,222 patients and demonstrated a significant reduction in the primary composite endpoint of CV death, hospitalization for HF, and urgent HF visits, with a hazard ratio (HR) of 0.67 (95% CI 0.52-0.85, p = 0.0009)[3][4].
  • SOLOIST-WHF Trial: Similar to SOLOIST, this trial showed a reduction in the primary endpoint, with 70 vs. 98 events/100 patient-years for sotagliflozin vs. placebo (HR 0.67, 95% CI 0.52-0.85, p = 0.0009). The trial also highlighted improvements in patient-centric outcomes such as days alive and out of the hospital[4].

SCORED Trial

The SCORED trial focused on patients with T2DM and CKD, evaluating the effect of sotagliflozin on CV and renal events.

  • Primary Endpoint: The trial was stopped early due to funding issues related to COVID-19 but still showed a significant reduction in the primary endpoint of CV death, HF hospitalization, and urgent HF visits, with an HR of 0.74 (95% CI 0.63-0.88, p = 0.0004)[1][3].

Key Findings Across Trials

  • Cardiovascular Outcomes: Sotagliflozin consistently reduced the risk of CV death, HF hospitalization, and urgent HF visits across all trials.
  • Renal Outcomes: Although the SCORED trial was terminated early, the pooled analysis of SCORED and SOLOIST-WHF data suggested benefits in renal endpoints, though not as pronounced due to the early termination[1][3][4].
  • Glycemic Control: The SOTA-INS trial, a secondary analysis, showed that sotagliflozin improved glycemic control in patients with T2DM on basal insulin therapy, achieving blood glucose levels within the target range for a significant portion of the day[2].

Market Analysis and Projections

Current Market Size and Growth

The North America SGLT2 inhibitors market, which includes sotagliflozin, is substantial and growing.

  • Current Market Size: The market was valued at USD 7.32 billion in 2024[5].
  • Projected Growth: The market is expected to grow from USD 7.93 billion in 2025 to USD 16.37 billion by 2034, with a compound annual growth rate (CAGR) of 8.4% during this period[5].

Market Drivers and Trends

  • Increasing Prevalence of Diabetes and CKD: The rising incidence of T2DM and CKD is driving the demand for effective treatments like SGLT2 inhibitors.
  • Clinical Efficacy: The positive outcomes from trials such as SOLOIST, SOLOIST-WHF, and SCORED have enhanced the market's confidence in sotagliflozin.
  • Financial Stability of Lexicon Pharmaceuticals: The company's solid balance sheet and significant cash position support ongoing research and development efforts, contributing to market optimism[2].

Competitive Landscape

The SGLT2 inhibitors market is competitive, with several established players. However, sotagliflozin's unique dual inhibition mechanism and its demonstrated benefits in both CV and renal outcomes position it favorably.

  • Analyst Outlook: Recent trial data has led analysts to maintain a positive outlook on Lexicon Pharmaceuticals, with a Buy rating and a price target of $10.00, indicating a potential 30% upside[2].

Financial Health and Revenue Growth

Lexicon Pharmaceuticals has shown significant financial growth, which is crucial for the continued development and marketing of sotagliflozin.

  • Revenue Growth: The company experienced a dramatic revenue growth of nearly 794.59% over the last twelve months as of Q2 2024, reflecting the market's optimism about sotagliflozin's potential[2].
  • Cash Position: Lexicon's solid balance sheet, with a cash position that outweighs its debt, supports its ongoing research and development efforts[2].

Regulatory Status

Sotagliflozin has faced regulatory challenges in the past but is currently on a positive trajectory.

  • Previous Regulatory Issues: A Complete Response letter in 2019 highlighted concerns about diabetic ketoacidosis (DKA) associated with sotagliflozin in patients with type 1 diabetes mellitus (T1DM). However, recent trials have focused on T2DM and CKD, where the benefit-risk profile is more favorable[3].
  • Current Regulatory Status: The recent submission of the NDA 216203 includes data from the SOLOIST and SCORED trials, supporting the proposed indications for reducing CV and renal events in adults with T2DM, CKD, and other CV risk factors[3].

Patient-Centric Outcomes

The trials have not only demonstrated clinical efficacy but also improved patient-centric outcomes.

  • Days Alive and Out of Hospital: The SOLOIST-WHF trial showed that patients on sotagliflozin had more days alive and out of the hospital compared to those on placebo[4].
  • Time to Benefit: The trials indicated that the benefits of sotagliflozin can be observed as early as 27 days after initiation, with sustained reductions in HF hospitalizations and urgent visits[4].

Conclusion

Sotagliflozin has shown significant promise in clinical trials, particularly in reducing CV and renal events in patients with T2DM and CKD. The market for SGLT2 inhibitors is growing, driven by the increasing prevalence of diabetes and CKD, and sotagliflozin's unique dual inhibition mechanism positions it well within this market.

Key Takeaways

  • Clinical Efficacy: Sotagliflozin reduces CV death, HF hospitalization, and urgent HF visits in patients with T2DM and CKD.
  • Market Growth: The North America SGLT2 inhibitors market is projected to grow at a CAGR of 8.4% from 2025 to 2034.
  • Financial Stability: Lexicon Pharmaceuticals' solid financial health supports ongoing development and marketing efforts.
  • Regulatory Progress: Recent trials support the proposed indications for sotagliflozin, overcoming previous regulatory hurdles.
  • Patient-Centric Benefits: Sotagliflozin improves days alive and out of the hospital, with benefits observable as early as 27 days after initiation.

FAQs

What are the primary indications for sotagliflozin?

Sotagliflozin is indicated to reduce the risk of cardiovascular death, hospitalization for heart failure, and urgent heart failure visits in adults with heart failure, including those with acute or worsening heart failure, and in adults with type 2 diabetes mellitus, chronic kidney disease, and other cardiovascular risk factors[3].

How does sotagliflozin compare to other SGLT2 inhibitors?

Sotagliflozin is a dual SGLT1 and SGLT2 inhibitor, which distinguishes it from other SGLT2 inhibitors. This dual mechanism may offer additional benefits in glycemic control and cardiovascular outcomes[2][3].

What were the key findings from the SOLOIST and SCORED trials?

The SOLOIST and SCORED trials showed significant reductions in cardiovascular events, including CV death, HF hospitalization, and urgent HF visits, with benefits observed as early as 27 days after initiation[1][3][4].

How does sotagliflozin impact glycemic control?

The SOTA-INS trial demonstrated that sotagliflozin improves glycemic control in patients with T2DM on basal insulin therapy, achieving blood glucose levels within the target range for a significant portion of the day[2].

What is the current market size and projected growth for SGLT2 inhibitors?

The North America SGLT2 inhibitors market was valued at USD 7.32 billion in 2024 and is projected to grow to USD 16.37 billion by 2034, with a CAGR of 8.4% during this period[5].

Sources

  1. American College of Cardiology: "Effect of Sotagliflozin on Cardiovascular and Renal Events in Patients With Type 2 Diabetes and Chronic Kidney Disease: The SCORED Trial."
  2. Investing.com: "Analyst sees 30% upside for Lexicon as new trial data boosts sotagliflozin's prospects."
  3. FDA: "Integrated Review for NDA 216203 - Sotagliflozin."
  4. American College of Cardiology: "Effect of Sotagliflozin on Cardiovascular Events in Patients With Type 2 Diabetes and Heart Failure: The SOLOIST-WHF Trial."
  5. Polaris Market Research: "North America SGLT2 Inhibitors Market Size, Analysis & Forecast."

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