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Clinical trials for Diabetes AND Insulin glargine (HOE901) AND Insulin

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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    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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    32 result(s) found for: Diabetes AND Insulin glargine (HOE901) AND Insulin. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2014-004640-35 Sponsor Protocol Number: EFC11681 Start Date*: 2015-03-17
    Sponsor Name:Sanofi
    Full Title: A 24-week, Randomized, Open-label, Parallel Group, Multicenter Comparison of Lantus® (Insulin Glargine) Given Once Daily Versus Neutral Protamine Hagedorn (NPH) Insulin in Children With Type 1 Diab...
    Medical condition: Type 1 Diabetes Mellitus
    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: 2015-004843-38 Sponsor Protocol Number: LPS14585 Start Date*: 2016-01-20
    Sponsor Name:Sanofi-Aventis Groupe
    Full Title: A Randomized, Double-blind, 2x2 Cross-over Euglycemic Clamp Study in Two Parallel Cohorts to Compare the Pharmacodynamic and Pharmacokinetic Properties of 0.4 and 0.6 U/kg/day Insulin Glargine (Tou...
    Medical condition: Type1 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    18.1 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2010-023770-39 Sponsor Protocol Number: EFC11629 Start Date*: 2011-10-28
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin glargine and Lantus® both in combination with oral antihyperglyc...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    16.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PT (Completed) ES (Completed) HU (Completed) FI (Completed)
    Trial results: View results
    EudraCT Number: 2012-000146-35 Sponsor Protocol Number: EFC12347 Start Date*: 2012-10-12
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® in Insulin-Naïve Patients with Type 2 Diabe...
    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: DK (Completed) SE (Completed) FI (Completed) EE (Completed) CZ (Completed) LV (Completed) LT (Completed) NL (Completed) BG (Completed) SK (Completed)
    Trial results: View results
    EudraCT Number: 2015-002084-42 Sponsor Protocol Number: EFC13957 Start Date*: 2016-07-11
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: 6-Month, Multicenter, Randomized, Open-label, 2-Arm, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected Once Daily in Children and ...
    Medical condition: Type 1 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    19.0 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (Completed) HU (Completed) LV (Completed) IT (Completed) DE (Completed) CZ (Completed) FR (Completed) ES (Completed) PL (Completed) SE (Completed) DK (Completed) BG (Completed) Outside EU/EEA
    Trial results: View results
    EudraCT Number: 2010-023769-23 Sponsor Protocol Number: EFC11628 Start Date*: 2011-09-30
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both plus Mealtime Insulin in 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: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed) HU (Completed) CZ (Completed) LV (Completed) EE (Completed) SE (Completed) FI (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2021-005353-82 Sponsor Protocol Number: LPS17375 Start Date*: 2022-05-09
    Sponsor Name:Sanofi-Aventis S.A
    Full Title: Prospective study to assess with Continuous Glucose Monitoring (CGM) the efficacy and safety of switching to insulin glargine 300 U/ml from insulin glargine 100 U/ml in Type 2 Diabetes (T2DM) patie...
    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: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002416-33 Sponsor Protocol Number: GLARGL07667 Start Date*: 2016-02-15
    Sponsor Name:sanofi-aventis France
    Full Title: An interventional, Open-label, single-arm, multicenter, 24 Weeks phase 4 study assessing the Efficacy and Safety of Toujeo in patients with Type 2 Diabetes inadequately controlled with Basal Insulin
    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: FR (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: 2012-001524-35 Sponsor Protocol Number: EFC12456 Start Date*: 2012-10-12
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: A 6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Injected in the Morning or Evening in Pat...
    Medical condition: Type 1 diabetes mellitus
    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: DK (Completed) SE (Completed) FI (Completed) CZ (Completed) LV (Completed) HU (Completed) NL (Completed) EE (Completed)
    Trial results: View results
    EudraCT Number: 2015-001626-42 Sponsor Protocol Number: LPS14409 Start Date*: 2015-11-27
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: A 24-Week, Multicenter, Randomized, Open-Label, 2-Arm Parallel-group Study Evaluating the Efficacy and Safety of Patient- Versus Physician-managed Titration of Insulin Glargine U300 in Type 2 Diabe...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    19.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) GB (Completed) ES (Completed) SK (Completed) DK (Completed) GR (Completed) SI (Completed) PL (Completed) HR (Completed)
    Trial results: View results
    EudraCT Number: 2015-005101-36 Sponsor Protocol Number: LPS14584 Start Date*: 2016-05-06
    Sponsor Name:sanofi-aventis Groupe
    Full Title: A 24-Week, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of Toujeo® and Tresiba® in Insulin-Naive Patients with Type 2 Diabetes Mellitus Not Adequately...
    Medical condition: Type 2 diabetes mellitus
    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: DK (Completed) SE (Completed) GR (Completed) HU (Completed) CZ (Completed) SK (Completed) FR (Completed) GB (Completed) SI (Completed) BG (Completed) HR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2015-001167-39 Sponsor Protocol Number: GLARGL07537 Start Date*: 2015-06-01
    Sponsor Name:Sanofi S.p.A.
    Full Title: Studio nazionale, randomizzato, controllato, in aperto, a gruppi paralleli per confrontare l’efficacia e la sicurezza di due diversi approcci con algoritmo di titolazione (gestito dal medico vs ges...
    Medical condition: Type 2 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    18.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: View results
    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: 2009-011231-12 Sponsor Protocol Number: EFC11202 Start Date*: 2009-11-11
    Sponsor Name:sanofi-aventis recherche & développement
    Full Title: A 24-week, randomized, open-label, parallel group multinational comparison of Lantus® (insulin glargine) given in the morning as once-a-day basal insulin versus Neutral Protamine Hagedorn (NPH) ins...
    Medical condition: Patients with type 1 diabetes mellitus, aged at least 1 year to less than 6 years
    Disease: Version SOC Term Classification Code Term Level
    12.0 10012609 LLT
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: HU (Completed) CZ (Completed) ES (Completed) DE (Completed) AT (Completed) Outside EU/EEA
    Trial results: View results
    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: 2017-003370-13 Sponsor Protocol Number: LPS15017 Start Date*: 2018-10-10
    Sponsor Name:Sanofi-Aventis Groupe
    Full Title: A multi-center open-label parallel group randomized controlled trial to compare iGlarLixi versus premixed insulin in patients with type 2 diabetes who have failed to achieve glycemic control with b...
    Medical condition: Patients with Type 2 Diabetes who have failed to achieve glycemic control with basal insulin and oral antidiabetic agents(OADs)
    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) AT (Completed) ES (Completed) SE (Completed) BG (Completed) GR (Completed) RO (Completed)
    Trial results: View results
    EudraCT Number: 2014-001253-16 Sponsor Protocol Number: PDY14065 Start Date*: 2014-08-19
    Sponsor Name:Sanofi-aventis recherche & développement
    Full Title: A multi-center, open-label, single-arm, multiple dose study with HOE901-U300 to assess the Ease of Use and Safety of a new U300 pen injector in insulin-naïve patients with T2DM
    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: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2014-002399-10 Sponsor Protocol Number: EFC13799 Start Date*: 2015-01-08
    Sponsor Name:Sanofi-aventis recherche & développement
    Full Title: A Randomized, Open-label, 2-arm Parallel-group, Multicenter, 26-week Study Assessing the Safety and Efficacy of H0E901-U300 Versus Lantus in Older Patients with Type 2 Diabetes Inadequately Control...
    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: Elderly Gender: Male, Female
    Trial protocol: SE (Completed) HU (Completed) DE (Completed) ES (Completed) IT (Completed) GB (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2005-002958-21 Sponsor Protocol Number: HOE901/4059 Start Date*: 2005-09-21
    Sponsor Name:Sanofi-Synthelabo Rt.
    Full Title: The determination of the exact time of administration of Lantus basal insulin for treating type 2 diabetes mellitus patients poorly controlled with basal insulin associated with oral antidiabetic d...
    Medical condition: Type 2 diabetes mellitus
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (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
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