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Clinical trials for 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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    23 result(s) found for: Metformin XR. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2020-003731-22 Sponsor Protocol Number: MK-0431A-296 Start Date*: 2020-09-03
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Study to Assess the Pharmacokinetics and Ability for Pediatric Patients with Type 2 Diabetes to Swallow MK-0431A XR Tablets
    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: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2012-004035-23 Sponsor Protocol Number: 0431A-0289 Start Date*: 2013-03-20
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase III Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A XR (a Fixed-Dose Combination Tablet of Sitagliptin and Extended-...
    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 Gender: Male, Female
    Trial protocol: CZ (Completed) IT (Completed) HU (Completed) DK (Completed) BG (Prematurely Ended) Outside EU/EEA GR (Completed)
    Trial results: View results
    EudraCT Number: 2019-003940-61 Sponsor Protocol Number: MINT Start Date*: 2020-12-07
    Sponsor Name:Uppsala county council
    Full Title: Metformin Intervention in children and adolescents with obesity. A parallel, three arms, randomized, 6 months, multi-center study with metformin extended release (XR) plus lifestyle or metformin i...
    Medical condition: Children and Adolscents with obesity
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2014-003583-20 Sponsor Protocol Number: 0431A-170-03 Start Date*: 2014-12-30
    Sponsor Name:Merck Sharp & Dohme Corp. a subsidiary of Merck & Co., Inc
    Full Title: A Phase III, Multicenter, Double-Blind, Randomized, Placebo -Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-0431A (A Fixed-Dose Combination Tablet of Sitagliptin and Metformin...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (Completed)
    Trial results: View results
    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: 2011-000400-17 Sponsor Protocol Number: JNJ28431754DIA3011 Start Date*: 2013-08-08
    Sponsor Name:Janssen-Cilag International NV
    Full Title: A Randomized, Double-Blind, 5-Arm, Parallel-Group, 26-Week, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of Canagliflozin in Combination With Metformin as Initial Combinatio...
    Medical condition: Type 2 Diabetes Mellitus With Inadequate Glycemic Control With Diet and Exercise
    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: HU (Completed) CZ (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2015-004990-34 Sponsor Protocol Number: MK-0431-845 Start Date*: 2016-05-11
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc
    Full Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Efficacy and Safety of the Continuation of Sitagliptin Compared with the Withdrawal of Sitagliptin...
    Medical condition: Type 2 Diabetes Mellitus (T2DM)
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: EE (Completed) HU (Completed) LV (Completed) CZ (Completed) ES (Completed) DK (Completed) RO (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-004224-59 Sponsor Protocol Number: MK-0431-848 Start Date*: 2016-07-27
    Sponsor Name:Merck Sharp & Dohme Corp.
    Full Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Study the Safety and Efficacy of the Addition of Sitagliptin During Metformin Up-titration Compared with Met...
    Medical condition: Type 2 Diabetes mellitus
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: CZ (Completed)
    Trial results: View results
    EudraCT Number: 2011-002529-23 Sponsor Protocol Number: 0431A-170 Start Date*: 2011-12-30
    Sponsor Name:Merck Sharp & Dohme Corp., a Subsidiary of Merck & Co.
    Full Title: MK-0431A Protocol 170-04: “A Phase III, Multicenter, Double-Blind, Randomized, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy MK-0431A (A Fixed-Dose Combination Tablet of Si...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    17.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: LV (Completed) LT (Prematurely Ended) GB (Completed) IT (Completed) DE (Completed) BG (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-006054-82 Sponsor Protocol Number: CL2-05720-005 Start Date*: 2012-06-29
    Sponsor Name:Institut de Recherches Internationales Servier
    Full Title: Efficacy and safety assessment of two schemes of oral administration of once-daily extended release metformin (metformin XR) in type 2 diabetic patients previously treated with metformin in combina...
    Medical condition: Type 2 diabetes
    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) HU (Completed) SK (Completed) PL (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: 2016-001233-27 Sponsor Protocol Number: PI2016_843_0008 Start Date*: 2016-11-03
    Sponsor Name:CHU Amiens Picardie
    Full Title: Efficacity and safety of metformin extended release (XR) in diabetic patients with CKD in stages 1 to 3 (METXR/CKD)
    Medical condition: type 2 diabetes
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (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: 2012-004531-23 Sponsor Protocol Number: CV181-206 Start Date*: 2013-07-26
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A 24-Week International, Multi-center, Randomized, Parallel-group, Double-blind Trial to Evaluate Metformin Extended Release Monotherapy Compared to Metformin Immediate Release Monotherapy in Adult...
    Medical condition: Type 2 Diabetes.
    Disease: Version SOC Term Classification Code Term Level
    18.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) DE (Completed) HU (Completed) GB (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2009-012806-37 Sponsor Protocol Number: D1690C00010 Start Date*: 2009-10-29
    Sponsor Name:AstraZeneca AB
    Full Title: A 24-week, Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, International Phase III Study with a 24-week Extension Period to Evaluate the Safety and Efficacy of Dapagliflo...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    12.0 10012613 Diabetes mellitus non-insulin-dependent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-002767-42 Sponsor Protocol Number: 2015-588 Start Date*: 2016-06-29
    Sponsor Name:Aarhus University Hospital
    Full Title: Effects of metformin treatment on myocardial efficiency in patients with heart failure: A randomized, double-blind, placebo-controlled study
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004849 10008908 Chronic heart failure LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    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: 2014-003189-26 Sponsor Protocol Number: Version1.2 Start Date*: 2014-12-01
    Sponsor Name:University of Dundee/NHS Tayside
    Full Title: Metformin and its Effects on Myocardial Dimension and Left ventricular hypertrophy in normotensive patients with Coronary Artery Disease.
    Medical condition: Cardiovascular disease
    Disease: Version SOC Term Classification Code Term Level
    17.0 10027433 - Metabolism and nutrition disorders 10022489 Insulin resistance PT
    17.0 100000004866 10051615 Atherosclerotic cardiovascular disease LLT
    17.0 100000004849 10025164 LVH LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (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: 2016-002056-25 Sponsor Protocol Number: MK-8521-004 Start Date*: 2016-09-06
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.
    Full Title: A Phase IIa, Multicenter, Placebo- and Active-controlled, Randomized, Double-Blind, Clinical Trial to Evaluate the Safety and Efficacy of MK-8521 Compared to Placebo in Subjects with Type 2 Diabete...
    Medical condition: Type 2 Diabetes Mellitus
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: ES (Prematurely Ended)
    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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