Safety and Efficacy Study of Sotagliflozin on Glucose Control in Participants With Type 2 Diabetes, Moderate Impairment of Kidney Function, and Inadequate Blood Sugar Control (SOTA-CKD3)
A Randomized, Double-blind, Placebo-controlled, 3-arm, Parallel-group 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients With Type 2 Diabetes Mellitus and Moderate Renal Impairment Who Have Inadequate Glycemic Control
Sponsor: Lexicon Pharmaceuticals
Listed as NCT03242252, this PHASE3 trial focuses on Chronic Kidney Disease Stage 3 and Type 2 Diabetes Mellitus and remains completed. Sponsored by Lexicon Pharmaceuticals, it has been updated 33 times since 2017, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.
Study Description(click to expand)The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment, and a visit 4 weeks after completion of the randomized treatment period.
The study duration is up to 60 weeks including 4 weeks prior to randomization, 52 weeks of randomized treatment, and a visit 4 weeks after completion of the randomized treatment period.
Status Flow
Change History
33 versions recorded-
Jan 2026 — Present [monthly]
Completed PHASE3
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Sep 2025 — Present [monthly]
Completed PHASE3
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Sep 2024 — Sep 2025 [monthly]
Completed PHASE3
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Jul 2024 — Sep 2024 [monthly]
Completed PHASE3
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Sep 2021 — Jul 2024 [monthly]
Completed PHASE3
▶ Show 28 earlier versions
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Jan 2021 — Sep 2021 [monthly]
Completed PHASE3
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Jun 2020 — Jan 2021 [monthly]
Completed PHASE3
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May 2020 — Jun 2020 [monthly]
Completed PHASE3
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Mar 2020 — May 2020 [monthly]
Completed PHASE3
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Dec 2019 — Mar 2020 [monthly]
Completed PHASE3
Status: Active Not Recruiting → Completed
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Oct 2019 — Dec 2019 [monthly]
Active Not Recruiting PHASE3
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Jul 2019 — Oct 2019 [monthly]
Active Not Recruiting PHASE3
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Jun 2019 — Jul 2019 [monthly]
Active Not Recruiting PHASE3
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May 2019 — Jun 2019 [monthly]
Active Not Recruiting PHASE3
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Apr 2019 — May 2019 [monthly]
Active Not Recruiting PHASE3
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Mar 2019 — Apr 2019 [monthly]
Active Not Recruiting PHASE3
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Feb 2019 — Mar 2019 [monthly]
Active Not Recruiting PHASE3
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Jan 2019 — Feb 2019 [monthly]
Active Not Recruiting PHASE3
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Dec 2018 — Jan 2019 [monthly]
Active Not Recruiting PHASE3
Status: Recruiting → Active Not Recruiting
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Nov 2018 — Dec 2018 [monthly]
Recruiting PHASE3
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Oct 2018 — Nov 2018 [monthly]
Recruiting PHASE3
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Sep 2018 — Oct 2018 [monthly]
Recruiting PHASE3
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Aug 2018 — Sep 2018 [monthly]
Recruiting PHASE3
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Jun 2018 — Aug 2018 [monthly]
Recruiting PHASE3
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May 2018 — Jun 2018 [monthly]
Recruiting PHASE3
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Apr 2018 — May 2018 [monthly]
Recruiting PHASE3
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Mar 2018 — Apr 2018 [monthly]
Recruiting PHASE3
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Feb 2018 — Mar 2018 [monthly]
Recruiting PHASE3
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Jan 2018 — Feb 2018 [monthly]
Recruiting PHASE3
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Dec 2017 — Jan 2018 [monthly]
Recruiting PHASE3
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Nov 2017 — Dec 2017 [monthly]
Recruiting PHASE3
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Oct 2017 — Nov 2017 [monthly]
Recruiting PHASE3
Status: Not Yet Recruiting → Recruiting
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Sep 2017 — Oct 2017 [monthly]
Not Yet Recruiting PHASE3
First recorded
Aug 2017
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
Anderson, United States , Ashkelon, Israel , Austin, United States , Bacau, Romania , Baja, Hungary , Balatonfüred, Hungary , Barcelona, Spain , Barranquilla, Colombia , Beaumont, United States , Beersheba, Israel and 130 more locations