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 (inTandem2)
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of LX4211 as Adjunct Therapy in Adult Patients With Type 1 Diabetes Mellitus Who Have Inadequate Glycemic Control With Insulin Therapy
Sponsor: Lexicon Pharmaceuticals
This PHASE3 trial investigates Type 1 Diabetes Mellitus and is currently completed. Lexicon Pharmaceuticals leads this study, which shows 11 recorded versions since 2015 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.
Status Flow
Change History
11 versions recorded-
Sep 2025 — Present [monthly]
Completed PHASE3
-
Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
-
Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
-
Jan 2021 — Jul 2024 [monthly]
Completed PHASE3
-
Mar 2020 — Jan 2021 [monthly]
Completed PHASE3
▶ Show 6 earlier versions
-
Nov 2019 — Mar 2020 [monthly]
Completed PHASE3
-
Jun 2018 — Nov 2019 [monthly]
Completed PHASE3
-
Jan 2018 — Jun 2018 [monthly]
Completed PHASE3
-
Nov 2017 — Jan 2018 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Feb 2017 — Nov 2017 [monthly]
Active Not Recruiting PHASE3
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Jan 2017 — Feb 2017 [monthly]
Active Not Recruiting PHASE3
First recorded
May 2015
Trial started
Per CT.gov start date — pre-dates our first snapshot
Eligibility Summary
No eligibility information available.
Contact Information
- Lexicon Pharmaceuticals
- Sanofi
For direct contact, visit the study record on ClinicalTrials.gov .
Study Locations
Antwerp, Belgium , Bacau, Romania , Barcelona, Spain , Birmingham, United Kingdom , Blackburn, United Kingdom , Bratislava, Slovakia , Bristol, United Kingdom , Brussels, Belgium , Bucharest, Romania , Budapest, Hungary and 68 more locations