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Clinical trials for Sotagliflozin

The European Union Clinical Trials Register   allows you to search for protocol and results information on:
  • interventional clinical trials that were approved in the European Union (EU)/European Economic Area (EEA) under the Clinical Trials Directive 2001/20/EC
  • clinical trials conducted outside the EU/EEA that are linked to European paediatric-medicine development

    • EU/EEA interventional clinical trials approved under or transitioned to the Clinical Trial Regulation 536/2014 are publicly accessible through the
    Clinical Trials Information System (CTIS).

    The EU Clinical Trials Register currently displays   44334   clinical trials with a EudraCT protocol, of which   7366   are clinical trials conducted with subjects less than 18 years old.   The register also displays information on   18700   older paediatric trials (in scope of Article 45 of the Paediatric Regulation (EC) No 1901/2006).

    Phase 1 trials conducted solely on adults and that are not part of an agreed paediatric investigation plan (PIP) are not publicly available (see Frequently Asked Questions ).  
     
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    13 result(s) found for: Sotagliflozin. Displaying page 1 of 1.
    EudraCT Number: 2016-001804-43 Sponsor Protocol Number: EFC14868 Start Date*: 2017-11-02
    Sponsor Name:Sanofi-aventis Recherche & Développement
    Full Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin in Patients with Type 2 Diabetes Who Have Inadequate G...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) CZ (Completed) SK (Prematurely Ended) BG (Completed)
    Trial results: View results
    EudraCT Number: 2016-001801-17 Sponsor Protocol Number: EFC14838 Start Date*: 2018-01-18
    Sponsor Name:Lexicon Pharmaceuticals, Inc.
    Full Title: A 52-week Randomized, Double-blind, Double-dummy, Active and Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin compared to Glimepiride or Pl...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) BG (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2017-003510-16 Sponsor Protocol Number: EFC15156 Start Date*: 2018-05-07
    Sponsor Name:Lexicon Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Effects of Sotagliflozin on Clinical Outcomes in Hemodynamically Stable Patients with Type 2 Diabet...
    Medical condition: Cardiovascular diseases
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10019279 Heart failure LLT
    21.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) NL (Completed) ES (Prematurely Ended) LV (Completed) LT (Completed) GB (Completed) BE (Completed) DK (Prematurely Ended) FR (Completed) AT (Completed) CZ (Prematurely Ended) DE (Completed) SK (Completed) HU (Completed) FI (Completed) PT (Completed) GR (Completed) PL (Completed) IE (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2017-002644-32 Sponsor Protocol Number: EFC14875 Start Date*: 2017-11-14
    Sponsor Name:SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    Full Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Demonstrate the Effects of Sotagliflozin on Cardiovascular and Renal Events in Patients with Type 2 Diabetes, Ca...
    Medical condition: Type 2 diabetes mellitus Chronic kidney disease
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    20.0 10038359 - Renal and urinary disorders 10064848 Chronic kidney disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Prematurely Ended) LV (Completed) GB (Completed) HU (Completed) SE (Completed) NO (Completed) FR (Completed) NL (Completed) DK (Completed) ES (Prematurely Ended) LT (Completed) EE (Completed) PT (Completed) BE (Completed) GR (Completed) BG (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2017-002774-39 Sponsor Protocol Number: PDY15079 Start Date*: 2018-01-23
    Sponsor Name:SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    Full Title: An Exploratory, Randomized, Double-blind, Placebo-controlled, Parallel Arm Trial of the Safety and Pharmacodynamic Activity of Sotagliflozin in Hemodynamically Stable Patients with Worsening Heart ...
    Medical condition: Cardiac Failure aggravated
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004849 10007557 Cardiac failure aggravated LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2016-001803-22 Sponsor Protocol Number: EFC14867 Start Date*: 2017-12-22
    Sponsor Name:SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    Full Title: A 26-week Randomized, Double-blind, Controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin compared to Empagliflozin, and Placebo in Patients with Type 2...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) CZ (Completed) ES (Completed) LV (Completed) SK (Completed) BG (Completed) FR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-001800-49 Sponsor Protocol Number: EFC14834 Start Date*: 2016-11-29
    Sponsor Name:Sanofi-aventis Recherche & Développement
    Full Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to Metformin in Patients with Type 2 Diabetes Mellitus W...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2016-002826-35 Sponsor Protocol Number: EFC14835 Start Date*: 2017-04-24
    Sponsor Name:Lexicon Pharmaceuticals, Inc.
    Full Title: A Randomized, Double-blind, Placebo-controlled, Parallel-group, Multicenter Study to Evaluate the Efficacy and Safety of Sotagliflozin Added to a Sulfonylurea alone or in combination with Metformin...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) SK (Completed) HU (Completed) GB (Completed) PL (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2017-002309-36 Sponsor Protocol Number: PDY15010 Start Date*: 2018-02-21
    Sponsor Name:SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    Full Title: A randomized, double-blind, parallel-group, 2-treatment multiple dose study to assess the intestinal, metabolic and cardiovascular effects of an 8 weeks treatment with sotagliflozin QD as compared ...
    Medical condition: Diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10012601 Diabetes mellitus PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2015-001709-15 Sponsor Protocol Number: LX4211.1-312-T1DM Start Date*: 2015-12-30
    Sponsor Name:Lexicon Pharmaceuticals, Inc.
    Full Title: A Phase 3, Randomized, Double-blind, Placebocontrolled, Parallel-group, Multicenter Study to Evaluate the Net Clinical Benefit of Sotagliflozin as Adjunct to Insulin Therapy in Type 1 Diabetes
    Medical condition: Type 1 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    18.0 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) CZ (Completed) BE (Completed) SK (Completed) GB (Completed) ES (Completed) BG (Completed) PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2016-004906-32 Sponsor Protocol Number: EFC15166 Start Date*: 2017-12-21
    Sponsor Name:Lexicon Pharmaceuticals, Inc.
    Full Title: 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 Se...
    Medical condition: Type 2 diabetes mellitus Chronic kidney disease stage 4
    Disease: Version SOC Term Classification Code Term Level
    21.0 100000004857 10076411 Chronic kidney disease stage 4 LLT
    21.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) ES (Completed) HU (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2016-004889-26 Sponsor Protocol Number: EFC14837 Start Date*: 2017-09-01
    Sponsor Name:Sanofi-aventis Recherche & Développement
    Full Title: 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 Mo...
    Medical condition: Type 2 diabetes mellitus Chronic kidney disease stage 3
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    20.0 100000070575 10076410 Chronic kidney disease stage 3 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) HU (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2014-005153-39 Sponsor Protocol Number: LX4211.1-310-T1DM Start Date*: 2015-04-28
    Sponsor Name:Lexicon Pharmaceuticals, Inc.
    Full Title: 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 Typ...
    Medical condition: Type 1 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    17.1 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SK (Completed) AT (Completed) ES (Completed) LT (Completed) DE (Completed) GB (Completed) HU (Completed) BE (Completed) SE (Completed) NL (Completed) PL (Completed) BG (Completed) RO (Completed) IT (Completed)
    Trial results: View results
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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