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Clinical trials for Intensive insulin therapy

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   44356   clinical trials with a EudraCT protocol, of which   7382   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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    37 result(s) found for: Intensive insulin therapy. Displaying page 1 of 2.
    1  2  Next»
    EudraCT Number: 2016-003738-25 Sponsor Protocol Number: ESR-16-12160/UKE-DapEx-001 Start Date*: 2017-12-28
    Sponsor Name:University Medical Center Hamburg-Eppendorf
    Full Title: A 28-week, multi-center randomized, double-blind, placebo-controlled study to evaluate the potential of Dapagliflozin plus Exenatide in combination with high-dose intensive insulin therapy compared...
    Medical condition: Obese insulin-resistant patients with Type 2 Diabetes mellitus (T2DM) and inadequate glycemic control (HbA1c ≥ 8.0% and ≤ 11.0%)
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2006-003076-35 Sponsor Protocol Number: F3Z-VI-S019 Start Date*: 2006-09-26
    Sponsor Name:Eli Lilly and Company Ltd.
    Full Title: Treatment Strategies in Patients with Type 2 Diabetes Mellitus Not Achieving Glycemic Control while on Therapy with Premixed Insulin Analogues and Metformin: A Comparison of Insulin Lispro MM Inte...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    8.1 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-002590-73 Sponsor Protocol Number: 901 Start Date*: 2005-11-14
    Sponsor Name:Andromeda Biotech Ltd.
    Full Title: A phase III, multinational, randomised, double-blind, placebo-controlled, parallel-group study to investigate the clinical efficacy and safety of Diapep277 in newly diagnosed type I Diabetes patients.
    Medical condition: Type I Diabetes
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10045228 Type I diabetes mellitus LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: FI (Completed) CZ (Completed) ES (Completed) AT (Completed) GB (Completed) DE (Completed) GR (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2014-001969-27 Sponsor Protocol Number: GLP111892 Start Date*: 2014-11-19
    Sponsor Name:GlaxoSmithKline Research & Development Limited
    Full Title: Albiglutide Versus Placebo as Add-on to Intensified Basal-Bolus Insulin Therapy in Subjects With Type 2 Diabetes Mellitus
    Medical condition: Diabetes mellitus type 2
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: HU (Prematurely Ended) DE (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2013-002775-17 Sponsor Protocol Number: 1010 Start Date*: 2013-10-29
    Sponsor Name:Andromeda Biotech Ltd
    Full Title: OPEN-LABEL STUDY TO EVALUATE LONG TERM SAFETY AND TREATMENT EFFECT OF DIAPEP277® IN SUBJECTS WHO HAVE COMPLETED STUDY 1001
    Medical condition: Type I diabetes
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004861 10045228 Type I diabetes mellitus LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Prematurely Ended) CZ (Prematurely Ended) HU (Prematurely Ended) AT (Prematurely Ended) LT (Prematurely Ended) ES (Prematurely Ended) PL (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-015929-37 Sponsor Protocol Number: 1001 Start Date*: 2010-09-02
    Sponsor Name:Andromeda Biotech Ltd, 42 Hayarkon st, Yavne, 81227, Israel
    Full Title: A PHASE III, MULTINATIONAL, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL-GROUP STUDY TO INVESTIGATE THE CLINICAL EFFICACY AND SAFETY OF DIAPEP277® IN NEWLY DIAGNOSED TYPE 1 DIABETES SUBJECTS
    Medical condition: Type I diabetes
    Disease: Version SOC Term Classification Code Term Level
    17.0 100000004861 10045228 Type I diabetes mellitus LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: HU (Completed) ES (Completed) DE (Completed) IT (Completed) AT (Completed) CZ (Completed) LT (Completed) FI (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2018-004680-31 Sponsor Protocol Number: 2018-004680-31 Start Date*: 2019-08-16
    Sponsor Name:Lene Ringholm
    Full Title: A randomised controlled trial comparing the effect of the faster-acting insulin analog - insulin Fiasp® – versus insulin Novorapid® in the treatment of women with type 1 or type 2 diabetes during p...
    Medical condition: Type 1 and type 2 diabetes during pregnancy and lactation
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10012614 Diabetes mellitus NOS LLT
    20.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults Gender: Female
    Trial protocol: DK (Completed)
    Trial results: View results
    EudraCT Number: 2010-018775-17 Sponsor Protocol Number: TRX4_DM_019_EU_10 Start Date*: 2010-07-02
    Sponsor Name:GlaxoSmithKline
    Full Title: DEFEND 2: Durable-Response Therapy Evaluation For Early- or New-Onset Type 1 Diabetes
    Medical condition: Type 1 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10012608 Diabetes mellitus insulin-dependent LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) DE (Prematurely Ended) FI (Completed) GB (Completed) ES (Completed) IT (Completed) DK (Completed) BE (Completed) NL (Completed)
    Trial results: View results
    EudraCT Number: 2005-003281-41 Sponsor Protocol Number: CL3-05590-013 Start Date*: 2005-09-02
    Sponsor Name:Institut de Recherches Internationales Servier [...]
    1. Institut de Recherches Internationales Servier
    2. Institute for International Health
    3. Institute for International Health
    Full Title: A factorial randomised trial of blood pressure lowering with a fixed low-dose perindopril-indapamide combination and intensive glucose control with a modified-release gliclazide-based regimen for t...
    Medical condition: Type II Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    7.0 10012613 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IE (Completed)
    Trial results: View results
    EudraCT Number: 2016-002725-11 Sponsor Protocol Number: GBB18 Start Date*: 2016-09-09
    Sponsor Name:UNIVERSITà DEGLI STUDI DI PERUGIA
    Full Title: HEAD TO HEAD COMPARISON IN PHARMACOKINETICS AND PHARMACODYNAMICS, AND CLINICAL EFFICACY BETWEEN INSULIN GLARGINE U300 AND INSULIN DEGLUDEC IN TYPE 1 DIABETES
    Medical condition: type 1 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-022549-59 Sponsor Protocol Number: TRX4_DM_J20_GER_10 Start Date*: 2011-03-03
    Sponsor Name:Tolerx, Inc.
    Full Title: DEFEND 2A: Durable-Response Therapy Evaluation For Early- or New-Onset Type 1 Diabetes in Adolescents
    Medical condition: Type 1 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    12.1 10012608 Diabetes mellitus insulin-dependent LLT
    Population Age: Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2009-013090-18 Sponsor Protocol Number: NN2211-3619 Start Date*: 2012-02-10
    Sponsor Name:Novo Nordisk A/S
    Full Title: A 52-Week Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Center, Multinational Exploratory Trial In Islet Cell Transplant Subjects With Type 1 Diabetes Mellitus To Evaluate The...
    Medical condition: Diabetes Mellitus, Type 1
    Disease: Version SOC Term Classification Code Term Level
    15.0 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2005-001693-27 Sponsor Protocol Number: 05/Q1606/30 Start Date*: 2005-06-24
    Sponsor Name:Oxford Radcliffe Hospitals NHS Trust
    Full Title: Pilot Effectiveness of Randomised Mandatory Insulin Therapy
    Medical condition: Those admitted to the Intensive Care Unit for treatment and likely to remain on the unit for longer than 5 days.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2020-003715-94 Sponsor Protocol Number: IDEAL Start Date*: 2020-12-17
    Sponsor Name:Institute for Clinical and Experimental Medicine
    Full Title: INSULIN THERAPY DE-INTENSIFICATION WITH iGlarLixi
    Medical condition: Type 2 diabetes mellitus
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: CZ (Completed) HU (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2005-000319-87 Sponsor Protocol Number: NN304-1657 Start Date*: 2005-08-03
    Sponsor Name:Novo Nordisk Pharma GmbH
    Full Title: A 52 week, Open Labelled, Randomised multi-centre 2 Arm Parallel Group Trial comparing Efficacy and Safety of Insulin Aspart, given in a Fixed Dose Regimen or in a Flexible Regimen, with or without...
    Medical condition: Type II diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    8.0 10045242 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2008-001210-25 Sponsor Protocol Number: CIT-01 Start Date*: 2008-05-27
    Sponsor Name:National Institute of Allergy and Infectious Diseases (NIAID), NIH
    Full Title: Open Randomized Multi-Center Study to Evaluate Safety and Efficacy of Low Molecular Weight Sulfated Dextran in Islet Transplantation.
    Medical condition: Type 1 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045228 Type I diabetes mellitus LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: View results
    EudraCT Number: 2008-002205-40 Sponsor Protocol Number: OTX115495 (DEFEND-1 EU) Start Date*: 2008-08-29
    Sponsor Name:Tolerx, Inc. [...]
    1. Tolerx, Inc.
    2. GlaxoSmithKline
    Full Title: DEFEND-1: Durable-Response Therapy Evaluation For Early- or New-Onset Type 1 Diabetes
    Medical condition: Otelixizumab is being developed for the treatment of patients with autoimmune T1DM with residual beta cell function (RBCF), with the goal of preserving RBCF in this patient population. There are cu...
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10012608 Diabetes mellitus insulin-dependent LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: SE (Completed) FI (Completed) GB (Completed) DE (Completed) DK (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2020-001317-20 Sponsor Protocol Number: IMCY-T1D-003 Start Date*: 2020-09-11
    Sponsor Name:Imcyse SA
    Full Title: A Phase Ib/IIa, randomized, double-blind placebo-controlled, multicenter adaptive design clinical trial to evaluate the immune signature of the treatment with the Imotope™ IMCY-0098 and its effect ...
    Medical condition: Type 1 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) BE (Completed) SI (Completed) LT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: (No results available)
    EudraCT Number: 2020-000435-45 Sponsor Protocol Number: Ver-A-T1D Start Date*: 2021-03-24
    Sponsor Name:Medical University of Graz
    Full Title: A randomised, double-blind, placebo controlled, parallel group, multi-centre trial in adult subjects with newly diagnosed type 1 diabetes mellitus investigating the effect of Verapamil SR on preser...
    Medical condition: Type 1 diabetes mellitus(T1DM)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DE (Ongoing) AT (Ongoing) BE (Trial now transitioned) FR (Trial now transitioned) IT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2017-000043-40 Sponsor Protocol Number: GLOBE2017 Start Date*: 2017-04-24
    Sponsor Name:Academic Medical Center
    Full Title: GLP-1 for bridging of hyperglycaemia during cardiac surgery: a randomized controlled trial
    Medical condition: Hyperglyceamia during Cardiac Surgery
    Disease: Version SOC Term Classification Code Term Level
    20.0 100000004861 10060439 Stress induced hyperglycaemia LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (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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