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Clinical trials for Lixisenatide

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
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    • 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   44341   clinical trials with a EudraCT protocol, of which   7370   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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    29 result(s) found for: Lixisenatide. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2014-002263-15 Sponsor Protocol Number: LIXISL07016 Start Date*: 2014-10-10
    Sponsor Name:sanofi aventis S.p.A
    Full Title: Effects of GLP-1 Receptor Agonist Lixisenatide on Post-prandial Lipid Profile in Obese Type 2 Diabetic Patients
    Medical condition: Effect of GLP-1 receptor agonist lixisenatide on post-prandial lipid profile in obese patients
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-003131-30 Sponsor Protocol Number: EFC12404 Start Date*: 2014-01-22
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: A randomized, 30 week, active-controlled, open-label, 3-treatment arm, parallel-group multicenter study comparing the efficacy and safety of insulin glargine/ lixisenatide fixed ratio combination t...
    Medical condition: Type II Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    17.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed) BE (Completed) IT (Completed) EE (Completed) SE (Completed) LT (Completed) LV (Completed) CZ (Completed) ES (Completed) HU (Completed) DK (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2013-002259-14 Sponsor Protocol Number: TRG12-05 Start Date*: 2013-11-27
    Sponsor Name:University of Oxford
    Full Title: The effect of lixisenatide in type 1 diabetes
    Medical condition: Type 1 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10012601 Diabetes mellitus PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2013-002826-22 Sponsor Protocol Number: Tobeallocatedlater Start Date*: 2013-10-17
    Sponsor Name:University of Surrey
    Full Title: The effect of Lixisenatide on triacylglycerol and glucose metabolism in patients with type 2 diabetes
    Medical condition: Type 2 Diabetes
    Disease:
    Population Age: Adults Gender: Male
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2009-012852-26 Sponsor Protocol Number: EFC11319 Start Date*: 2010-09-06
    Sponsor Name:sanofi-aventis Recherche & Développement
    Full Title: Estudio multicéntrico doble ciego, aleatorizado, controlado con placebo y de grupos paralelos, para evaluar los eventos cardiovasculares durante el tratamiento con lixisenatide en pacientes con dia...
    Medical condition: Diabetes tipo II ___________________ Type II Diabetes
    Disease: Version SOC Term Classification Code Term Level
    12.1 10067585 Type 2 diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) PT (Completed) GB (Completed) LT (Completed) EE (Completed) DK (Completed) LV (Completed) IT (Completed) NL (Completed) SE (Completed) FR (Completed) FI (Completed) BG (Completed) BE (Completed) NO (Completed) AT (Completed)
    Trial results: View results
    EudraCT Number: 2015-005789-42 Sponsor Protocol Number: TDR14311 Start Date*: 2016-08-02
    Sponsor Name:SANOFI-AVENTIS RECHERCHE ET DEVELOPPEMENT
    Full Title: Randomized, Double-blind, Placebo-controlled, Dose escalation, Study on Safety, Pharmacokinetics and Pharmacodynamics of Lixisenatide in Pediatric Patients with Type 2 Diabetes Mellitus Not Adequat...
    Medical condition: Pediatric Patients with Type 2 Diabetes Mellitus Not Adequately Controlled with Metformin and/or Basal Insulin
    Disease: Version SOC Term Classification Code Term Level
    19.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: ES (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2013-005334-37 Sponsor Protocol Number: LixiBit Start Date*: 2014-05-23
    Sponsor Name:Medical University of Vienna / Medizinische Universität Wien
    Full Title: Effects of once-daily administered GLP-1 Receptoragonist Lixisenatide in combination with basal Insulin on glycemic control in patients with type-2 diabetes mellitus not achieving therapeutic targe...
    Medical condition: 10 patients (both gender) under treatment with premixed insulin (2-3 injections) and HbA1c>7% will be switched to basal insulin glargine (Lantus, once daily) and GLP-1 receptor agonist Lixisenatide...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2014-002178-35 Sponsor Protocol Number: DC2014ELIX001 Start Date*: 2014-08-06
    Sponsor Name:VU University Medical Center
    Full Title: A phase 4, monocenter, randomized, open label, comparator-controlled, parallel-group, mechanistic intervention trial to assess the effect of 8-week treatment with the glucagon-like peptide-1 recept...
    Medical condition: Type 2 Diabetes Mellitus
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2012-004096-38 Sponsor Protocol Number: EFC12626 Start Date*: 2013-03-27
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: A randomized, open-label, active-controlled, 3-arm parallel-group, 26-week study comparing the efficacy and safety of lixisenatide to that of insulin glulisine once daily and insulin glulisine thre...
    Medical condition: Type 2 Diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) HU (Completed) ES (Completed) IT (Completed) DE (Completed) PL (Completed) EE (Completed) LV (Completed) LT (Completed)
    Trial results: View results
    EudraCT Number: 2012-003292-19 Sponsor Protocol Number: EFC12703 Start Date*: 2013-06-04
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: A randomized, double-blind, placebo-controlled, 2-arm parallel-group, multicenter, 24 week study assessing the safety and efficacy of lixisenatide in older patients with type 2 diabetes inadequatel...
    Medical condition: Type 2 Diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GB (Completed) SE (Completed) ES (Completed) NO (Completed) DE (Completed) DK (Completed) BG (Completed)
    Trial results: View results
    EudraCT Number: 2008-007335-40 Sponsor Protocol Number: EFC10781 Start Date*: 2009-10-01
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: A randomized, placebo-controlled, 2-arm parallel-group, multicenter study with a 24-week double-blind treatment period assessing the efficacy and safety of lixisenatide in patients with Type 2 dia...
    Medical condition: Type II Diabetes
    Disease: Version SOC Term Classification Code Term Level
    11.1 10045242 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) FR (Completed) EE (Completed) NL (Completed) CZ (Completed) HU (Completed) DK (Completed) IT (Completed) PL (Completed) DE (Completed) GR (Completed)
    Trial results: View results
    EudraCT Number: 2012-000027-40 Sponsor Protocol Number: PDY12625 Start Date*: 2012-04-26
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: An open-label, randomized, three-parallel-group study on pharmacodynamic effects of 8-week QD treatment with lixisenatide compared to liraglutide in patients with type 2 diabetes not adequately con...
    Medical condition: Type 2 Diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    15.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2013-003132-79 Sponsor Protocol Number: EFC12405 Start Date*: 2014-01-21
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: A randomized, 30-week, active-controlled, open label, 2-treatment arm, parallel-group, multicenter study comparing the efficacy and safety of the insulin glargine/lixisenatide fixed ratio combinati...
    Medical condition: Type II Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    17.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) SE (Completed) LT (Completed) CZ (Completed) NL (Completed) ES (Completed) HU (Completed) SK (Completed) DK (Completed)
    Trial results: View results
    EudraCT Number: 2011-002416-85 Sponsor Protocol Number: EFC12261 Start Date*: 2012-03-21
    Sponsor Name:sanofi-aventis Recherche et Développement
    Full Title: A 24-week, open-label, randomized, 2-arm parallel group, multinational, multi-center clinical trial to compare the efficacy and safety of lixisenatide injected prior to the main meal of the day ver...
    Medical condition: Type II Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) ES (Completed) DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2016-001758-17 Sponsor Protocol Number: LAST Start Date*: 2016-11-14
    Sponsor Name:King's College London [...]
    1. King's College London
    2. Guy's and St Thomas' NHS Foundation Trust
    Full Title: Effect of Lixisenatide on arterial stiffness in patients with diabetic nephropathy
    Medical condition: Type 2 diabetes
    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 (GB - no longer in EU/EEA)
    Trial results: (No results available)
    EudraCT Number: 2011-004584-67 Sponsor Protocol Number: PKD11475 Start Date*: 2012-08-27
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: A randomized, double-blind, placebo controlled trial to assess safety, tolerability, pharmacokinetics and pharmacodynamics of lixisenatide in paediatric (10 - 17 years old) and adult patients with ...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-004984-27 Sponsor Protocol Number: NN2211-3867 Start Date*: 2013-09-09
    Sponsor Name:Novo Nordisk A/S
    Full Title: Efficacy and safety of liraglutide versus lixisenatide as add-on to metformin in subjects with type 2 diabetes
    Medical condition: Diabetes Mellitus, Type 2
    Disease: Version SOC Term Classification Code Term Level
    16.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LT (Completed) FI (Completed) GB (Completed) CZ (Completed) DE (Completed) HU (Completed) LV (Completed) FR (Completed)
    Trial results: View results
    EudraCT Number: 2020-003715-94 Sponsor Protocol Number: IDEAL Start Date*: 2020-12-17
    Sponsor Name:Institute for Clinical and Experimental Medicine
    Full Title: INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi
    Medical condition: Type 2 diabetes mellitus
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-017666-23 Sponsor Protocol Number: PDY10931 Start Date*: 2010-07-10
    Sponsor Name:sanofi-aventis
    Full Title: An open-label, randomized, two-arm parallel group study to compare the effects of 4-week QD treatment with lixisenatide or liraglutide on the postprandial plasma glucose in patients with type 2 dia...
    Medical condition: Diabetes
    Disease: Version SOC Term Classification Code Term Level
    12.1 10045242 Type II diabetes mellitus LLT
    Population Age: Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-004850-32 Sponsor Protocol Number: EFC13794 Start Date*: 2016-06-17
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: A 26-Week Randomized, Open-label, Active Controlled, Parallel-group, Study Assessing the Efficacy and Safety of the Insulin Glargine/Lixisenatide Fixed Ratio Combination in Adults with Type 2 Diabe...
    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: SK (Completed) EE (Completed) ES (Completed) DE (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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