Flag of the European Union EU Clinical Trials Register Help

Clinical trials for Apidra (insulin glulisine)

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   44344   clinical trials with a EudraCT protocol, of which   7373   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
     
    24 result(s) found for: Apidra (insulin glulisine). Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2009-015742-34 Sponsor Protocol Number: APIDR_L_04717 Start Date*: 2009-12-11
    Sponsor Name:sanofi-aventis
    Full Title: Better Accepance of a Singe injection Apidra (insulin glulisine) Added to once daily Lantus (insulin glargine) versus twice daily Premixed insulin in a real Life Use Setting.
    Medical condition: Type 2 Diabetes Mellitus
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2015-004536-35 Sponsor Protocol Number: IIT-14652 Start Date*: Information not available in EudraCT
    Sponsor Name:Kinder- und Jugendkrankenhaus AUF DER BULT
    Full Title: Lipoatrophy in children, adolescents and adults with modern treatment modalities: is there a beneficial effect of insulin glulisine?
    Medical condition: Type 1 Diabetes mellitus and Lipoatrophy
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-000616-70 Sponsor Protocol Number: HMR1964D/3001 Start Date*: 2004-12-17
    Sponsor Name:Aventis Pharmaceuticals, Inc.
    Full Title: Efficacy and safety of insulin glulisine compared with insulin lispro in children and adolescents with type 1 diabetes mellitus: a 26-week, multicenter, open, parallel clinical trial
    Medical condition: Type 1 diabetes mellitus
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DK (Completed) NO (Completed) FI (Completed) SE (Completed) HU (Completed) GB (Completed) DE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2006-005127-42 Sponsor Protocol Number: APIDR_L_01896 Start Date*: 2006-11-22
    Sponsor Name:Institut für Klinische Forschung und Entwicklung (ikfe) GmbH
    Full Title: Effect of Prandial Treatment with Insulin Glulisine compared to Regular Human Insulin on Postprandial Endothelial Function and Microvascular Stress in Type 2 Diabetic Patients
    Medical condition: Diabetes mellitus Type 2
    Disease: Version SOC Term Classification Code Term Level
    8.1 10012601 Diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2004-002036-25 Sponsor Protocol Number: HMR1964A/3506 Start Date*: 2005-01-27
    Sponsor Name:sanofi aventis groupe
    Full Title: Comparison of three therapeutic strategies for treating type 2 diabetes mellitus patients poorly controlled with basal insulin associated with oral antidiabetic drugs.
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    8.1 10045242 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) BE (Completed) IT (Completed) SE (Completed) ES (Completed) LT (Completed) GR (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: 2013-004737-33 Sponsor Protocol Number: 5706 Start Date*: 2018-05-16
    Sponsor Name:Hôpitaux Universitaires de Strasbourg
    Full Title: A prospective, multicenter, randomized, open-label study of 12 week duration to evaluate the effect of VILDagliptin added to insulin on glycaemic control in haemoDIALyzed patients with type 2 diabe...
    Medical condition: haemodialyzed patients with type 2 diabetes
    Disease: Version SOC Term Classification Code Term Level
    18.0 100000004861 10049746 Insulin-requiring type II diabetes mellitus LLT
    18.0 100000004865 10018874 Haemodialysed LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-004639-38 Sponsor Protocol Number: APIDR_L_04884 Start Date*: 2015-04-03
    Sponsor Name:Sanofi
    Full Title: A study of effectiveness and safety of Apidra in combination with Lantus therapy in basal-bolus insulin regimen in inadequately controlled children and adolescents with Type 1 diabetes in the Russi...
    Medical condition: Diabetes Mellitus, Type 1
    Disease: Version SOC Term Classification Code Term Level
    17.1 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: Outside EU/EEA
    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: 2016-002915-17 Sponsor Protocol Number: FIM-EOX-2016-01 Start Date*: 2016-11-03
    Sponsor Name:Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud (FIMABIS)
    Full Title: Impact on oxidative stress of novel analogues of insulin in people with type 1 diabetes. Low- intervention clinical trial. Ineox Study
    Medical condition: DIABETES TYPE 1
    Disease: Version SOC Term Classification Code Term Level
    19.0 10027433 - Metabolism and nutrition disorders 10022491 Insulin resistant diabetes PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2004-001287-49 Sponsor Protocol Number: HMR1964A/3504 Start Date*: 2004-12-21
    Sponsor Name:Sanofi-Aventis Deutschland GmbH
    Full Title: 52-week, open, randomized, multinational, multicenter clinical trial comparing insulin glulisine in combination with insulin glargine in an intensified insulin regimen to a two-injection convention...
    Medical condition: Diabetes mellitus type 2
    Disease: Version SOC Term Classification Code Term Level
    10012613
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed) CZ (Completed) ES (Completed) GB (Completed) SK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2007-003579-38 Sponsor Protocol Number: APIDR_C_02083 Start Date*: 2007-11-13
    Sponsor Name:sanofi-aventis groupe
    Full Title: Effect of insulin glulisine compared to insulin aspart and insulin lispro when administered by Continuous Subcutaneous Insulin Infusion (CSII) on specific pump parameters in patient with Type 1 Dia...
    Medical condition: Type I Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045228 Type I diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Completed) SE (Completed) NL (Completed) AT (Completed) HU (Completed) IT (Completed) ES (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2005-002614-38 Sponsor Protocol Number: HMR1964A/4002 Start Date*: 2006-09-07
    Sponsor Name:SANOFI AVENTIS GROUPE
    Full Title: COMPARISON OF TWO THERAPEUTIC STRATEGIES FOR TREATING TYPE 2 DIABETIC PATIENTS POORLY CONTROLLED WITH BASAL INSULIN ASSOCIATED WITH ORAL ANTIDIABETIC DRUGS: 6-MONTH PROOF OF CONCEPT STUDY
    Medical condition: Type II diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    8.1 10045242 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2008-007026-19 Sponsor Protocol Number: LANTU_L_04211 Start Date*: 2009-04-24
    Sponsor Name:Aventis Pharma Ltd trading as sanofi-aventis
    Full Title: COMPARISON OF A BASAL PLUS ONE INSULIN REGIMEN (INSULIN GLARGINE/INSULIN GLULISINE) WITH A BIPHASIC INSULIN REGIMEN (INSULIN ASPART/INSULIN ASPART PROTAMINE 30/70) IN TYPE 2 DIABETES PATIENTS FOLLO...
    Medical condition: Type II diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012601 Diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2017-000955-25 Sponsor Protocol Number: ClinDiab-08 Start Date*: 2017-05-12
    Sponsor Name:Medical University of Graz
    Full Title: A single-centre, open-label, randomized controlled trial of efficacy, safety and usability of a basal insulin algorithm incorporated in the GlucoTab system compared to standard care for glycaemic m...
    Medical condition: Diabetes mellitus type 2
    Disease: Version SOC Term Classification Code Term Level
    19.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: View results
    EudraCT Number: 2018-000863-98 Sponsor Protocol Number: GlucoTab@MobileCare Start Date*: 2018-06-25
    Sponsor Name:Medical University of Graz
    Full Title: A single-centre, open-label, non-controlled trial of acceptance, usability, safety and efficacy of a tablet based workflow and decision support system with incorporated basal-insulin algorithm for ...
    Medical condition: 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: AT (Completed)
    Trial results: View results
    EudraCT Number: 2008-000686-30 Sponsor Protocol Number: LIMBISCHEMIA Start Date*: 2008-02-26
    Sponsor Name:OSPEDALE S. RAFFAELE
    Full Title: Effect of glicemia normalization in fasting conditions by insulinic intensive treatment on frequency of restenosis after periferic angioplastic in patients affected by diabetes mellitus type II.
    Medical condition: diabetes mellitus type II
    Disease: Version SOC Term Classification Code Term Level
    9.1 10049746 Insulin-requiring type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2011-003733-34 Sponsor Protocol Number: APIDR_L_05719 Start Date*: 2011-09-13
    Sponsor Name:ikfe – Institute for Clinical Research and Development
    Full Title: Human Insulin Analogs: Evaluation of inflammatory mRNA expression of Macrophages and Endothelial function of Short-acting insulin – HERMES Pilot Study
    Medical condition: Patients with Diabetes mellitus Type 2 and a stable basal supported oral therapy
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10053247 Insulin-requiring type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2014-000969-47 Sponsor Protocol Number: 13702908 Start Date*: 2014-07-04
    Sponsor Name:University Hospital of Toulouse
    Full Title: Clinical efficacy of coordinated boluses in type 1 diabetic patients treated with insulin pumps: a multicentric, randomised, cross over study (COBOL study).
    Medical condition: type 1 diabetic patients
    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: FR (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003669-27 Sponsor Protocol Number: GlucoTab_U300 Start Date*: 2015-10-20
    Sponsor Name:Medizinische Universität Graz, Universitätsklinik für Innere Medizin, Klin.Abt. für Endokrinologie und Stoffwechsel
    Full Title: Glycemic control with GlucoTab using an ultra-long acting insulin analogue in non-critically ill patients with type 2 diabetes at the general ward
    Medical condition: Diabetes mellitus type 2
    Disease: Version SOC Term Classification Code Term Level
    18.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Gender: Male, Female
    Trial protocol: AT (Completed)
    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 Jun 20 07:44:21 CEST 2025 | Domenico Scarlattilaan 6, 1083 HS Amsterdam, The Netherlands
    EMA HMA