Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Saxagliptin

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 ).  
     
    Examples: Cancer AND drug name. Pneumonia AND sponsor name.
    How to search [pdf]
    Search Tips: Under advanced search you can use filters for Country, Age Group, Gender, Trial Phase, Trial Status, Date Range, Rare Diseases and Orphan Designation. For these items you should use the filters and not add them to your search terms in the text field.
    Advanced Search: Search tools
     
    38 result(s) found for: Saxagliptin. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2015-005406-11 Sponsor Protocol Number: D1683C00005 Start Date*: 2016-05-25
    Sponsor Name:Astrazeneca AB
    Full Title: A Multi-Center, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase III Trial to Evaluate the Safety and Efficacy of Saxagliptin 5mg Co-administered with Dapagliflozin 5mg compared t...
    Medical condition: Type 2 diabetes mellitus, inadequate glycaemic control
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2006-000006-23 Sponsor Protocol Number: CV181039 Start Date*: 2007-02-12
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Multicenter, Randomized, Double-Blind, Active-Controlled, Phase 3 Trial to Evaluate the Efficacy and Safety of Saxagliptin in Combination with Metformin IR as Initial Therapy Compared to Saxaglip...
    Medical condition: Type 2 Diabetes Mellitus
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) DE (Completed) IT (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: 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: 2015-002676-24 Sponsor Protocol Number: D1690C00023 Start Date*: 2015-11-24
    Sponsor Name:AstraZeneca AB
    Full Title: An exploratory Phase II/III, randomized, double-blind, placebo controlled, parallel design study to evaluate the efficacy, safety and pharmacodynamics of dapagliflozin and dapagliflozin in combinat...
    Medical condition: CKD3 patients with type 2 diabetes mellitus and albuminuria.
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004857 10045250 Type II diabetes mellitus with renal manifestations LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed)
    Trial results: View results
    EudraCT Number: 2015-002376-24 Sponsor Protocol Number: D1689C00014 Start Date*: 2015-10-06
    Sponsor Name:AstraZeneca AB
    Full Title: A 52-Week, Multi-Centre, Randomised, Parallel-Group, Double-Blind, Active Controlled, Phase IV Study to Evaluate the Safety and Efficacy of Dapagliflozin or Dapagliflozin plus Saxagliptin compared ...
    Medical condition: Type 2 diabetes mellitus, inadequate glycaemic control
    Disease: Version SOC Term Classification Code Term Level
    19.1 100000004860 10012602 Diabetes mellitus (incl subtypes) HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) CZ (Completed) SK (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2015-004723-31 Sponsor Protocol Number: ESR-14-10145 Start Date*: 2016-02-05
    Sponsor Name:UNIVERSITÀ CAMPUS BIO-MEDICO DI ROMA
    Full Title: Proof of concept study, a randomized, controlled, open and prospective period of one year to evaluate the effectiveness of treatment with saxagliptin / dapagliflozin + metformin vs insulin glargine...
    Medical condition: LADA
    Disease: Version SOC Term Classification Code Term Level
    21.0 10027433 - Metabolism and nutrition disorders 10066389 Latent autoimmune diabetes in adults PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-005140-41 Sponsor Protocol Number: Saxa-Dapa1 Start Date*: 2017-05-10
    Sponsor Name:AZIENDA OSPEDALIERO-UNIVERSITARIA PISANA
    Full Title: A PHASE II, RANDOMIZED, DOUBLE-BLIND, ACTIVE-CONTROLLED, PARALLEL-GROUP, SINGLE CENTER PILOT STUDY OF THE ACUTE AND CHRONIC EFFECTS OF DAPAGLIFLOZIN PLUS SAXAGLIPTIN IN ADDITION TO METFORMIN VERSUS...
    Medical condition: Patients with type 2 diabetes poorly controlled with metformin
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    23.0 10027433 - Metabolism and nutrition disorders 10012607 Diabetes mellitus inadequate control PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-005740-34 Sponsor Protocol Number: ESR-14-10698 Start Date*: 2017-12-08
    Sponsor Name:Universitätsklinikum Tübingen
    Full Title: Effectiveness of Dapagliflozin + Saxagliptin to revert from a standard basalbolus insulin treatment (BBIT) regimen to a basal supported oral therapy (BOT) in patients with Type 2 Diabetes – a rando...
    Medical condition: Diabetes Melitus Type 2
    Disease: Version SOC Term Classification Code Term Level
    20.0 10014698 - Endocrine disorders 10018424 Glucose metabolism disorders (incl diabetes mellitus) HLGT
    20.0 10027433 - Metabolism and nutrition disorders 10012601 Diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2015-004825-14 Sponsor Protocol Number: D1680C00016 Start Date*: 2016-05-04
    Sponsor Name:AstraZeneca AB
    Full Title: A 24-Week, Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled Study to Investigate the Effects of Saxagliptin, Saxagliptin Combined with Dapagliflozin, and Sitagliptin in Pat...
    Medical condition: Patients with type 2 diabetes mellitus and heart failure
    Disease: Version SOC Term Classification Code Term Level
    18.1 10007541 - Cardiac disorders 10011078 Coronary artery disease PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Prematurely Ended) HU (Completed) BG (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2009-017358-10 Sponsor Protocol Number: D1680C00003 Start Date*: 2010-03-26
    Sponsor Name:AstraZeneca AB
    Full Title: Saxagliptin Assessment of Vascular Outcomes Recorded in Patients with Diabetes Mellitus A Multicentre, Randomised, Double-Blind, Placebo-Controlled Phase IV Trial to Evaluate the Effect of Saxagl...
    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: HU (Completed) CZ (Completed) DE (Completed) ES (Completed) GB (Completed) FR (Completed) PL (Completed) SE (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-003721-18 Sponsor Protocol Number: CV181365 Start Date*: 2015-09-14
    Sponsor Name:AstraZeneca AB
    Full Title: A 52-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial with a Blinded 104-week Long -term Extension Period to Evaluate the Efficacy and Saf...
    Medical condition: Inadequately controlled Diabetes Mellitus Type 2.
    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: CZ (Completed) DE (Completed) HU (Completed) SE (Completed) PL (Completed) RO (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: 2009-010224-25 Sponsor Protocol Number: CV181-080 Start Date*: 2009-06-11
    Sponsor Name:Bristol-Myers Squibb International Corporation
    Full Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 3 Trial to Evaluate the Efficacy and Safety of 2.5 mg Saxagliptin, PO, BID, in Combination with Metformin in Subje...
    Medical condition: Type 2 Diabetes Mellitus
    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: HU (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2009-012816-41 Sponsor Protocol Number: D1680L00002 Start Date*: 2009-08-12
    Sponsor Name:AstraZeneca AB
    Full Title: A 52-Week, Randomised, Double-Blind, Active-Controlled, Multi-Centre Phase IIIb/IV Study to Evaluate the Efficacy and Tolerability of Saxagliptin Compared to Glimepiride in Elderly Patients with Ty...
    Medical condition: Non-insulin dependent type 2 diabetes mellitus in elderly patients (≥ 65 years)
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10029505 Non-insulin-dependent diabetes mellitus LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: SE (Completed) DE (Completed) DK (Completed) FI (Completed) ES (Completed) NO (Completed) AT (Completed) FR (Completed) GR (Completed) IT (Completed) GB (Completed) HU (Completed)
    Trial results: View results
    EudraCT Number: 2014-001102-17 Sponsor Protocol Number: CV181363 Start Date*: 2015-03-27
    Sponsor Name:AstraZeneca AB
    Full Title: A 26-week International, Multicenter, Randomized, Double-Blind, Active-Controlled, Parallel Group, Phase 3bTrial with a Blinded 26-week Long -term Extension Period to Evaluate the Efficacy and Safe...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    19.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2010-020360-38 Sponsor Protocol Number: CV181-058 Start Date*: 2011-10-31
    Sponsor Name:Bristol Myers Squibb International Corporation
    Full Title: A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacokinetics of Saxagliptin (BMS-477118) as Monotherapy in Pediatric Patien...
    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 IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2014-003788-39 Sponsor Protocol Number: ESR-14-10231 Start Date*: 2014-12-17
    Sponsor Name:Profil Mainz GmbH & Co KG
    Full Title: Effect of Saxagliptin in Addition to Dapagliflozin and Metformin on Insulin Resistance, Islet Cell Dysfunction, and Metabolic Control in Subjects with Type 2 Diabetes Mellitus on Previous Metformin...
    Medical condition: Type 2 Diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    17.1 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: 2010-018979-16 Sponsor Protocol Number: SAXA24011980GLIPTIN Start Date*: 2010-08-23
    Sponsor Name:University Hospital Erlangen
    Full Title: EFFECTS OF SAXAGLITPIN ON ENDOTHELIAL FUNCTION IN PATIENTS WITH TYPE 2 DIABETES
    Medical condition: diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    12.1 10012613 Diabetes mellitus non-insulin-dependent LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2007-004951-12 Sponsor Protocol Number: D1680C00007 Start Date*: 2008-02-05
    Sponsor Name:AstraZeneca AB
    Full Title: A Short-term 12-Week, Multi-centre, Randomized, Parallel-group, Double-blind, Placebo-controlled Study to Evaluate the Treatment Effect of Saxagliptin compared with Placebo in Adult Patients with T...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    9.1 10029505 Non-insulin-dependent diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: LV (Completed) LT (Completed) HU (Completed) CZ (Completed) EE (Completed) BG (Prematurely Ended)
    Trial results: View results
    Download Options:
    Number of Trials to download:
    Download Content:
    Download Format:
    Note, where multi-state trials are shown in search results, selecting "Full Trial details" will download full information for each of the member states/countries involved in the trial.
    1  2  Next»
    Query did not match any studies.
    For support, Contact us.
    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.

    European Medicines Agency © 1995-Fri May 02 07:56:56 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA