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Clinical trials for Isophane 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   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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    18 result(s) found for: Isophane insulin. Displaying page 1 of 1.
    EudraCT Number: 2012-000225-51 Sponsor Protocol Number: ITP-NODAT Start Date*: 2012-11-21
    Sponsor Name:Fundació Institut Mar d'investigacions Mediques
    Full Title: Insulin Therapy for the Prevention of New Onset Diabetes after Transplantation (ITP-NODAT) Prospective Study in Non-Diabetic De Novo Kidney Transplant Recipients
    Medical condition: Previously non-diabetic end stage renal disease patients undergoing kidney transplantation.
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) AT (Completed)
    Trial results: View results
    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: 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: 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: 2011-004622-96 Sponsor Protocol Number: 0431-260 Start Date*: 2011-12-23
    Sponsor Name:Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (hereafter referred to as
    Full Title: A Phase III, Multicenter, Randomized, Double-Blind, Placebo- Controlled Clinical Trial to Study the Safety and Insulin-Sparing Efficacy of the Addition of Sitagliptin in Patients With Type 2 Diabet...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.0 10027433 - Metabolism and nutrition disorders 10067585 Type 2 diabetes mellitus PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) IE (Completed) LT (Completed) DK (Completed) HU (Completed) BE (Completed) GB (Completed) IT (Completed) PT (Completed)
    Trial results: View results
    EudraCT Number: 2017-002101-35 Sponsor Protocol Number: HyperCarD2 Start Date*: 2017-08-24
    Sponsor Name:Sten Madsbad
    Full Title: THE ROLE OF HYPERGLYCEMIA, HYPERINSULINEMIA AND ELEVATED FREE FATTY ACIDS FOR CARDIAC FUNCTION IN PATIENTS WITH TYPE 2 DIABETES – THE HYPERCARD2 STUDY
    Medical condition: typé 2 diabetes
    Disease:
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: (No results available)
    EudraCT Number: 2010-018354-12 Sponsor Protocol Number: INSUGCT300509 Start Date*: 2010-07-19
    Sponsor Name:Biocon S.A.
    Full Title: A Randomized, Active Controlled, Parallel Group, Multicentre, Two-Phase, Open-Label Study Comparing the Safety and Immunogenicity of Insugen R and Insugen N with Actrapid and Insulatard in Patients...
    Medical condition: Type 1 Diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10045228 Type I diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: DE (Completed) HU (Completed) IT (Completed)
    Trial results: View results
    EudraCT Number: 2005-000976-42 Sponsor Protocol Number: NN304-1659 Start Date*: 2005-07-21
    Sponsor Name:Novo Nordisk Pharma S.A.
    Full Title: A multi-centre, open-labelled, randomised, two-group parallel, treat-to-target trial comparing the weight change in overweight and obese subjects with type 2 diabetes after 26 weeks of treatment wi...
    Medical condition: Type 2 diabetes
    Disease: Version SOC Term Classification Code Term Level
    7.0 10049746 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (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: 2006-006589-41 Sponsor Protocol Number: NN304-1808 Start Date*: 2007-05-04
    Sponsor Name:Novo Nordisk Pharmaceutique S.A.S
    Full Title: Levemir® in ageing patients with type 2 diabetes A seven-month open-labelled randomised multi-centre two-group parallel trial comparing administration of insulin detemir once daily in the morning...
    Medical condition: Type 2 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    9.1 10045242 Type II diabetes mellitus LLT
    Population Age: Elderly Gender: Male, Female
    Trial protocol: FR (Completed) GB (Prematurely Ended)
    Trial results: View results
    EudraCT Number: 2004-001461-18 Sponsor Protocol Number: NN304-1632 Start Date*: 2004-12-06
    Sponsor Name:NOVO NORDISK
    Full Title: A 20 week multi-national, open-labelled, randomised, three-group parallel trial comparing administration of insulin detemir morning, insulin detemir evening and NPH insulin evening as add-on to ora...
    Medical condition: Combined therapy in diabetes mellitus
    Disease: Version SOC Term Classification Code Term Level
    6.1 10012601 PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: IT (Completed) ES (Completed)
    Trial results: View results
    EudraCT Number: 2012-005583-10 Sponsor Protocol Number: NN1218-4049 Start Date*: 2013-05-15
    Sponsor Name:Novo Nordisk A/S
    Full Title: Efficacy and safety of FIAsp in a basal-bolus regimen versus basal insulin therapy, both in combination with metformin in adult Subjects with type 2 diabetes
    Medical condition: Diabetes Mellitus, Type 2
    Disease: Version SOC Term Classification Code Term Level
    14.1 100000004861 10045242 Type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: SI (Completed)
    Trial results: View results
    EudraCT Number: 2021-003711-25 Sponsor Protocol Number: LPS17008 Start Date*: 2021-12-15
    Sponsor Name:Sanofi-Aventis Recherche & Développement
    Full Title: A 24-Week, Single-Arm, Phase 4 Clinical Study to Evaluate the Efficacy and Safety of Switching to iGlarLixi in People with Type 2 Diabetes Mellitus Uncontrolled on Once or Twice Daily Premixed Insu...
    Medical condition: Uncontrolled 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: CZ (Completed) PL (Completed)
    Trial results: View results
    EudraCT Number: 2014-000904-88 Sponsor Protocol Number: 1218.149 Start Date*: 2014-08-05
    Sponsor Name:Boehringer Ingelheim Ellas SA
    Full Title: A 24 week randomized, double-blind, placebo-controlled, parallel group, efficacy and safety trial of once daily linagliptin, 5 milligrams orally, as add on to basal insulin in elderly Type 2 Diabet...
    Medical condition: Type 2 Diabetes Mellitus
    Disease:
    Population Age: Elderly Gender: Male, Female
    Trial protocol: GR (Completed) ES (Completed) DK (Completed) GB (Completed) FI (Completed) DE (Completed) BE (Completed) IE (Completed)
    Trial results: View results
    EudraCT Number: 2005-003980-21 Sponsor Protocol Number: NN304-1724 Start Date*: 2006-01-19
    Sponsor Name:Novo Nordisk Ltd
    Full Title: A Multinational, Open Label, Randomised, Three Period, Cross Over Trial Investigating The Impact Of Exercise And Type Of Basal Insulin Used On Blood Glucose Levels In Subjects With Type 1 Diabetes ...
    Medical condition: Type 1 Diabetes
    Disease: Version SOC Term Classification Code Term Level
    8.1 10045228 LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: GB (Completed) DE (Completed)
    Trial results: View results
    EudraCT Number: 2011-005866-39 Sponsor Protocol Number: I2R-MC-BIDJ Start Date*: 2012-04-18
    Sponsor Name:Lilly S.A.
    Full Title: A Comparison of LY2605541 versus Insulin Glargine Alone or in Combination with Pre study Oral Antihyperglycemic Medications in Patients with Type 2 Diabetes Mellitus Previously Treated with Basal I...
    Medical condition: Type 2 Diabetes Mellitus
    Disease: Version SOC Term Classification Code Term Level
    14.1 10027433 - Metabolism and nutrition disorders 10049746 Insulin-requiring type II diabetes mellitus LLT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: ES (Completed) DE (Completed) GR (Completed) CZ (Completed)
    Trial results: View results
    EudraCT Number: 2022-004195-42 Sponsor Protocol Number: FIT-05 Start Date*: 2023-04-13
    Sponsor Name:Elgan Pharma Ltd
    Full Title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Basket Study to Assess the Safety of ELGN-2112 in Populations of Interest
    Medical condition: Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10025479 Malabsorption syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) SE (Ongoing) ES (Ongoing) NL (Trial now transitioned) AT (Trial now transitioned)
    Trial results: (No results available)
    EudraCT Number: 2021-004890-29 Sponsor Protocol Number: FIT-PIV Start Date*: 2023-03-09
    Sponsor Name:Elgan Pharma Ltd
    Full Title: A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants
    Medical condition: Gastro-intestinal malabsorption due to gastro-intestinal immaturity in preterm infants.
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004856 10025479 Malabsorption syndrome LLT
    Population Age: Preterm newborn infants, Under 18 Gender: Male, Female
    Trial protocol: FR (Trial now transitioned) ES (Ongoing) SE (Trial now transitioned) NL (Trial now transitioned) AT (Trial now transitioned)
    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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