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Clinical trials for Saxagliptin + Metformin XR

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   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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    6 result(s) found for: Saxagliptin + Metformin XR. Displaying page 1 of 1.
    EudraCT Number: 2014-003964-18 Sponsor Protocol Number: CV181-153 Start Date*: 2014-10-02
    Sponsor Name:Bristol-Myers Squibb Company
    Full Title: Evaluation of the Pharmacokinetics of Saxagliptin, 5-Hydroxy Saxagliptin, and Metformin in Children and Adolescents Aged 10 to 17 Years with Type 2 Diabetes Mellitus Following Oral Administration o...
    Medical condition: Type 2 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: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: Removed from public view
    EudraCT Number: 2012-000679-18 Sponsor Protocol Number: CV181-169 Start Date*: 2012-11-13
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3 Trial to Evaluate the Safety and Efficacy of Add-On Therapy with Saxagliptin and Dapagliflozin added to Metformin...
    Medical condition: Type 2 Diabetes who have Inadequate Glycemic Control on Metformin Alone
    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: PL (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-005042-66 Sponsor Protocol Number: D1680C00019 Start Date*: 2017-11-08
    Sponsor Name:AstraZeneca AB
    Full Title: A 26 Week, Multicenter, Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase 3 Trial with a 26 Week Safety Extension Period Evaluating the Safety and Efficacy of Dapagliflozin 5 and ...
    Medical condition: Diabetes Mellitus Type 2
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FI (Completed) GB (GB - no longer in EU/EEA) PL (Completed) IT (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2008-000976-26 Sponsor Protocol Number: CV181-066 Start Date*: 2008-08-10
    Sponsor Name:BRISTOL-M.SQUIBB
    Full Title: A 4-Week, Multicenter, Randomized, Double-Blind, Placebo-Controlled Phase 3 Trial to Evaluate The Efficacy and Safety of Saxagliptin in Comparison to Placebo as Add-on Treatment to Metformin XR in ...
    Medical condition: Type II diabetes
    Disease: Version SOC Term Classification Code Term Level
    9.1 10063624 Type II diabetes mellitus inadequate control LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2010-024568-16 Sponsor Protocol Number: CV181-147 Start Date*: 2012-04-05
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Saxagliptin (BMS-477118) in Combination with Metformin IR or Metformin XR in Pediatric Patie...
    Medical condition: diabetes type 2
    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 Gender: Male, Female
    Trial protocol: BE (Completed) Outside EU/EEA GB (Completed) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-019428-30 Sponsor Protocol Number: D1680L00006 Start Date*: 2010-05-14
    Sponsor Name:AstraZeneca Singapore Pte Ltd
    Full Title: A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IIIb tudy to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin and Sulfonylurea in Subjects wi...
    Medical condition: Type 2 diabetes mellitus
    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: GB (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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