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Last Updated: August 5, 2021

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CLINICAL TRIALS PROFILE FOR SOTAGLIFLOZIN


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Clinical Trials for Sotagliflozin

Trial ID Title Status Sponsor Phase Summary
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 This Phase 2 study is intended to demonstrate superiority of Sotagliflozin versus placebo on A1C reduction at Week 12 in young adult patients with T1DM who have poor glycemic control on their current insulin regimen.
NCT02383940 ↗ Efficacy and Safety of Sotagliflozin in Young Adult Patients With Type 1 Diabetes Mellitus and Elevated Hemoglobin A1C Completed Lexicon Pharmaceuticals Phase 2 This Phase 2 study is intended to demonstrate superiority of Sotagliflozin versus placebo on A1C reduction at Week 12 in young adult patients with T1DM who have poor glycemic control on their current insulin regimen.
NCT02384941 ↗ Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy Active, not recruiting Lexicon Pharmaceuticals Phase 3 This Phase 3 study is intended to demonstrate superiority of either Sotagliflozin High dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult patients with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.
NCT02421510 ↗ Efficacy, Safety, and Tolerability Study of Sotagliflozin as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy Active, not recruiting Lexicon Pharmaceuticals Phase 3 This Phase 3 study is intended to demonstrate superiority of either Sotagliflozin high dose or low dose versus placebo on glycosylated hemoglobin A1C (A1C) reduction at Week 24 when used as an adjunct in adult patients with type 1 diabetes mellitus (T1D) who have inadequate glycemic control with insulin therapy.
>Trial ID >Title >Status >Phase >Summary

Clinical Trial Conditions for Sotagliflozin

Condition Name

Condition Name for
Intervention Trials
Type 2 Diabetes Mellitus 14
Diabetes Mellitus 6
Type 1 Diabetes Mellitus 6
Healthy Subjects 3
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Condition MeSH

Condition MeSH for
Intervention Trials
Diabetes Mellitus 29
Diabetes Mellitus, Type 2 17
Diabetes Mellitus, Type 1 7
Heart Failure 3
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Clinical Trial Locations for Sotagliflozin

Trials by Country

Trials by Country for
Location Trials
United States 110
Canada 10
New Zealand 6
France 5
United Kingdom 4
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Trials by US State

Trials by US State for
Location Trials
Florida 11
Texas 10
California 7
Colorado 6
Virginia 5
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Clinical Trial Progress for Sotagliflozin

Clinical Trial Phase

Clinical Trial Phase for
Clinical Trial Phase Trials
Phase 4 1
Phase 3 16
Phase 2 4
[disabled in preview] 13
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Clinical Trial Status

Clinical Trial Status for
Clinical Trial Phase Trials
Recruiting 13
Not yet recruiting 11
Active, not recruiting 5
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Clinical Trial Sponsors for Sotagliflozin

Sponsor Name

Sponsor Name for
Sponsor Trials
Sanofi 24
Lexicon Pharmaceuticals 8
Juvenile Diabetes Research Foundation 1
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Sponsor Type

Sponsor Type for
Sponsor Trials
Industry 32
Other 4
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Serving leading biopharmaceutical companies globally:

Merck
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Colorcon
AstraZeneca
Express Scripts
McKesson

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