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Clinical trials for recombinant human 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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    • 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   44338   clinical trials with a EudraCT protocol, of which   7368   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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    82 result(s) found for: recombinant human insulin. Displaying page 1 of 5.
    1  2  3  4  5  Next»
    EudraCT Number: 2005-001621-29 Sponsor Protocol Number: 80804002 Start Date*: 2009-05-05
    Sponsor Name:Faculty of Medicine Carl Gustav Carus, University of Technology, Dresden
    Full Title: Pre-POINT (Primary Oral INsulin Trial) study A dose finding safety and immune efficacy study for primary mucosal insulin therapy in islet autoantibody negative children at high genetic risk for ty...
    Medical condition: pre-type 1 diabetes (islet autoimmunity in non-diabetic relatives of subjects with type 1 diabetes)
    Disease:
    Population Age: Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) AT (Completed) GB (Completed)
    Trial results: View results
    EudraCT Number: 2015-003028-30 Sponsor Protocol Number: 808040019 Start Date*: 2015-11-02
    Sponsor Name:Technische Universität München, Fakultät für Medizin
    Full Title: Fr1da Insulin Intervention - Mechanistic study using oral insulin for immune and treatment efficacy in secondary prevention of type 1 diabetes
    Medical condition: Risk for type 1 diabetes
    Disease:
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-004691-22 Sponsor Protocol Number: RCT-004 Start Date*: 2017-11-21
    Sponsor Name:Rechon Life Science AB
    Full Title: A Randomised, Open, Parallel-group Phase III Biosimilarity Study to Assess the Long-term Safety, Focusing on Immunogenicity, of Rechon Insulin Human Soluble in Type 1 Diabetic Patients.
    Medical condition: Type 1 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10012601 Diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-005287-15 Sponsor Protocol Number: 808040017 Start Date*: 2015-07-15
    Sponsor Name:Technische Universität München, Fakultät für Medizin
    Full Title: - PRE-POINT-EARLY STUDY - Pilot study using oral insulin at early age for immune efficacy in primary prevention of type 1 diabetes
    Medical condition: Risk for type 1 diabetes
    Disease:
    Population Age: Infants and toddlers, Children, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed)
    Trial results: View results
    EudraCT Number: 2004-002455-13 Sponsor Protocol Number: TCW-01-04 Start Date*: 2004-12-30
    Sponsor Name:Dept. of Internal Medicine
    Full Title: Vergleich der Effektivität von Insulin Aspart und Normalinsulin bei Typ 2 Diabetikern hinsichtlich des postprandialen Stoffwechsels während zwei aufeinanderfolgender Mahlzeiten. Die Huckepack Studie
    Medical condition: Type-2 Diabetes treated with insulin
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: AT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2008-006763-36 Sponsor Protocol Number: 411-MA-08-01-0000 Start Date*: 2009-06-30
    Sponsor Name:Marvel Life Sciences Limited
    Full Title: Randomized, double-blind study comparing the immunogenicity of two different brands of human insulin for the treatment of diabetes
    Medical condition: Patients suffering from diabetes mellitus type 1 or 2 with the indication for insulin treatment and dependent on insulin administration.
    Disease: Version SOC Term Classification Code Term Level
    9.1 10012608 Diabetes mellitus insulin-dependent PT
    9.1 10018209 Gestational diabetes PT
    9.1 10049746 Insulin-requiring type II diabetes mellitus PT
    9.1 10051599 Diabetes mellitus management PT
    9.1 10012601 Diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) BG (Completed)
    Trial results: (No results available)
    EudraCT Number: 2016-001923-30 Sponsor Protocol Number: TN-20 Start Date*: 2016-09-26
    Sponsor Name:TRIALNET COORDINATING CENTER AT THE UNIVERSITY OF SOUTH FLORIDA
    Full Title: Exploring Immune Effects of Oral Insulin in Relatives at Risk for Type 1 Diabetes Mellitus
    Medical condition: Type 1 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10066284 Diabetes prophylaxis PT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-017329-20 Sponsor Protocol Number: INIT/002 Start Date*: 2010-09-07
    Sponsor Name:Melbourne Health, Royal Melbourne Hospital
    Full Title: A randomised, double-blind, placebo-controlled trial of intranasal insulin (440IU) in children and young adults at risk of type 1 diabetes: INTRANASAL INSULIN TRIAL II
    Medical condition: Type-1-Diabetes
    Disease:
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-021373-37 Sponsor Protocol Number: HUBIN_L_05335 Start Date*: 2010-09-15
    Sponsor Name:Sanofi-Aventis Recherche et Développement
    Full Title: Evaluation of Insuman Implantable 400 IU/ml in patients with Type 1 diabetes treated with the Medtronic MiniMed Implantable Pump System using Insuplant 400 IU/mL
    Medical condition: Type 1 diabetes
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: FR (Completed) NL (Completed) SE (Completed) BE (Completed)
    Trial results: View results
    EudraCT Number: 2017-003088-36 Sponsor Protocol Number: GPPAD-03-POInT Start Date*: 2018-01-30
    Sponsor Name:Technische Universität München, Represented by the school of medicine
    Full Title: GPPAD-POInT (Global Platform of Autoimmune Diabetes – Primary Oral Insulin Trial) Oral Insulin Therapy for Prevention of Autoimmune Diabetes
    Medical condition: risk for type 1 diabetes
    Disease: Version SOC Term Classification Code Term Level
    21.1 10042613 - Surgical and medical procedures 10066284 Diabetes prophylaxis PT
    Population Age: Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: SE (Completed) GB (GB - no longer in EU/EEA) PL (Completed) DE (Completed) BE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2009-016783-37 Sponsor Protocol Number: WS475202 Start Date*: 2010-01-07
    Sponsor Name:Sahlgrenska University Hospital
    Full Title: The Effects of 18-Month Replacement with a Very Low Fixed Dose vs. Standard Dose of Growth Hormone (GH) on Insulin Sensitivity, Body Composition, Bone Mass, Lipids, Muscle Strength and Quality of L...
    Medical condition: Growth hormone deficiency in adults
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SE (Completed)
    Trial results: (No results available)
    EudraCT Number: 2006-006550-96 Sponsor Protocol Number: TN-07 Start Date*: 2007-03-23
    Sponsor Name:NIDDK TYPE 1 DIABETES TRIALNET
    Full Title: Oral insulin for prevention of diabetes in relatives at risk for type 1 diabetes mellitus
    Medical condition: prevention of type 1 diabetes mellitus in subjects at risk for T1DM
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045228 Type I diabetes mellitus LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: IT (Completed) FI (Completed) DE (Completed) GB (Completed) SE (Completed)
    Trial results: View results
    EudraCT Number: 2019-002977-69 Sponsor Protocol Number: BEYOND Start Date*: 2019-11-14
    Sponsor Name:A.O.U. Università degli Studi della Campania "Luigi Vanvitelli"
    Full Title: Durability of combination of insulin and GLP-1 receptor agonist or SGLT-2 inhibitors versus basal bolus insulin regimen in type 2 diabetes: a randomized controlled trial
    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
    21.1 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed)
    Trial results: (No results available)
    EudraCT Number: 2005-004747-64 Sponsor Protocol Number: H7U-MC-IDAU Start Date*: 2006-01-09
    Sponsor Name:Eli Lilly and Company Ltd
    Full Title: A Phase 3, Open-Label, Parallel Group Study to Evaluate the Efficacy and Safety of Human Insulin Inhalation Powder (HIIP) Compared to Preprandial Injectable Insulin in Insulin-Naïve Patients with T...
    Medical condition: Male or female adults (>18 yrs), diagnosed type 2 diabetes mellitus for at least 6 months duration at study entry, taking at least one oral anti-hyperglycemic medication and are insulin-naïve. They...
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Prematurely Ended) HU (Prematurely Ended) PT (Prematurely Ended) IT (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2022-002356-39 Sponsor Protocol Number: D/P2/22/8 Start Date*: 2022-12-14
    Sponsor Name:Diamyd Medical AB
    Full Title: DiaPrecise, A Phase II Open Label Study to evaluate the safety and feasibility of intralymphatic administration of Diamyd® in individuals at risk for Type 1 diabetes carrying the HLA DR3-DQ2 haplotype
    Medical condition: Stage 1 or stage 2 pre-type1 diabetes (seropositive for two or more T1D–associated autoantibodies)
    Disease: Version SOC Term Classification Code Term Level
    21.1 10027433 - Metabolism and nutrition disorders 10067584 Type 1 diabetes mellitus PT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: SE (Trial now transitioned)
    Trial results: (No results available)
    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: 2010-020166-20 Sponsor Protocol Number: CACZ885I2208 Start Date*: 2011-01-06
    Sponsor Name:Novartis Pharma Services AG
    Full Title: A randomized, double-blind, multiple-dose, placebo-controlled, parallel group study to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics of ACZ885 in patient...
    Medical condition: Type-1 diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    12.1 10067584 Type 1 diabetes mellitus LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Prematurely Ended) DE (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2010-019660-36 Sponsor Protocol Number: Anakinra1 Start Date*: 2010-12-07
    Sponsor Name:UMC St Radboud
    Full Title: The effect of interleukin-1 receptor antagonist on insulin secretion
    Medical condition: Beta-cell dysfunction
    Disease: Version SOC Term Classification Code Term Level
    12.1 10052341 Impaired insulin secretion LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2011-001538-41 Sponsor Protocol Number: Start Date*: 2011-06-29
    Sponsor Name:University of Birmingham
    Full Title: The impact of the combination of the GLP-1 analogue liraglutide (Victoza) and laparoscopic adjustable gastric banding (LAGB) on diabetes control
    Medical condition: This trial will investigate the effects of the study treatment arms (gastric band + placebo; gastric band + liraglutide) on diabetes resolution in obese patients.
    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: GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2009-016022-14 Sponsor Protocol Number: PREVORAL 2 Start Date*: 2009-09-29
    Sponsor Name:UNIVERSITA` CAMPUS BIOMEDICO
    Full Title: Studio aperto per la valutazione dell efficacia dell insulina spray buccale sul controllo glicometabolico in soggetti con ridotta tolleranza ai carboidrati (studio PREVORAL 2).
    Medical condition: impaired glucose tolerance (IGT)
    Disease: Version SOC Term Classification Code Term Level
    12.0 10020638 Hyperglycaemic conditions NEC HLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Ongoing)
    Trial results: (No results available)
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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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