deltatrials
Completed PHASE3 INTERVENTIONAL 2-arm NCT02531035

A Phase 3 Study to Evaluate the Safety of Sotagliflozin in Patients With Type 1 Diabetes Who Have Inadequate Glycemic Control With Insulin Therapy Alone (inTandem3)

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes

Sponsor: Lexicon Pharmaceuticals

Updated 11 times since 2017 Last updated: Feb 10, 2020 Started: Sep 30, 2015 Primary completion: Apr 30, 2017 Completion: Apr 30, 2017
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on High Level of Sugar (Glucose) in the Blood and Type 1 Diabetes Mellitus (T1DM), this trial is completed. The trial is conducted by Lexicon Pharmaceuticals and has accumulated 11 data snapshots since 2015. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

~Jan 2017 – ~Feb 2017 · 31 days · monthly snapshotActive Not Recruiting~Feb 2017 – ~Nov 2017 · 9 months · monthly snapshotActive Not Recruiting~Nov 2017 – ~Jan 2018 · 2 months · monthly snapshotCompleted~Jan 2018 – ~Jun 2018 · 5 months · monthly snapshotCompleted~Jun 2018 – ~Dec 2019 · 18 months · monthly snapshotCompleted~Dec 2019 – ~Mar 2020 · 3 months · monthly snapshotCompleted~Mar 2020 – ~Jan 2021 · 10 months · monthly snapshotCompleted~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotCompleted~Sep 2024 – ~Sep 2025 · 12 months · monthly snapshotCompleted~Sep 2025 – present · 8 months · monthly snapshotCompleted

Change History

11 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE3

  2. Sep 2024 — Sep 2025 [monthly]

    Completed PHASE3

  3. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE3

  4. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE3

  5. Mar 2020 — Jan 2021 [monthly]

    Completed PHASE3

Show 6 earlier versions
  1. Dec 2019 — Mar 2020 [monthly]

    Completed PHASE3

  2. Jun 2018 — Dec 2019 [monthly]

    Completed PHASE3

  3. Jan 2018 — Jun 2018 [monthly]

    Completed PHASE3

  4. Nov 2017 — Jan 2018 [monthly]

    Completed PHASE3

    Status: Active Not RecruitingCompleted

  5. Feb 2017 — Nov 2017 [monthly]

    Active Not Recruiting PHASE3

  6. Jan 2017 — Feb 2017 [monthly]

    Active Not Recruiting PHASE3

    First recorded

Sep 2015

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Lexicon Pharmaceuticals
  • Sanofi
Data source: Lexicon Pharmaceuticals

For direct contact, visit the study record on ClinicalTrials.gov .