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Clinical trials for Hyperinsulinemia

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   43863   clinical trials with a EudraCT protocol, of which   7285   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: Hyperinsulinemia. Displaying page 1 of 1.
    EudraCT Number: 2012-004100-35 Sponsor Protocol Number: FSJD-PIOSPIMET-2012 Start Date*: 2012-12-20
    Sponsor Name:Fundació per la Recerca i la Docència Sant Joan de Déu
    Full Title: A prospective, open-label, randomized, two-armed clinical trial to evaluate the efficacy and safety of a combination of ethinyl-estradiol and levonorgestrel versus a low-dose combination of pioglit...
    Medical condition: Ovarian hyperandrogenism
    Disease:
    Population Age: Adolescents, Under 18, Adults Gender: Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-005092-24 Sponsor Protocol Number: FSJD-PIOSPIMET-2015 Start Date*: 2016-01-22
    Sponsor Name:FUNDACIÓ SANT JOAN DE DÉU
    Full Title: A prospective, open-label, randomized, two-armed clinical trial to evaluate the efficacy and safety of a combination of ethinyl-estradiol and levonorgestrel versus a low-dose combination of pioglit...
    Medical condition: ovarian hyperandrogenism with hyperinsulinaemia
    Disease:
    Population Age: Adolescents, Under 18 Gender: Female
    Trial protocol: ES (Completed)
    Trial results: (No results available)
    EudraCT Number: 2015-003317-22 Sponsor Protocol Number: 2015_01 Start Date*: 2017-09-28
    Sponsor Name:Centre Hospitalier Régional Universitaire Lille
    Full Title: 111In-DTPA-exendine 4 PET/CT in patients with AHH – a prospective comparative evaluation of preoperative imaging
    Medical condition:
    Disease: Version SOC Term Classification Code Term Level
    19.1 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    Population Age: Adults, Elderly Gender: Male, Female
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2016-001275-80 Sponsor Protocol Number: X358605 Start Date*: 2016-08-25
    Sponsor Name:XOMA (US) LLC
    Full Title: An Open-Label Study of XOMA 358, with Optional Dose Escalation, in Patients with Congenital Hyperinsulinism
    Medical condition: Hypoglycemia associated with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    19.0 10027433 - Metabolism and nutrition disorders 10077227 Hyperinsulinemic hypoglycemia LLT
    19.0 10027433 - Metabolism and nutrition disorders 10020644 Hyperinsulinism NOS LLT
    19.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    19.0 10027433 - Metabolism and nutrition disorders 10022484 Insulin hypoglycaemia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: DE (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: 2016-004186-83 Sponsor Protocol Number: RZ358-606 Start Date*: 2017-04-11
    Sponsor Name:Rezolute, Inc.
    Full Title: An Open-Label Multiple-Dose Study of RZ358 in Patients with Congenital Hyperinsulinism
    Medical condition: Hypoglycemia associated with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    20.1 10027433 - Metabolism and nutrition disorders 10077227 Hyperinsulinemic hypoglycemia LLT
    20.0 10027433 - Metabolism and nutrition disorders 10020644 Hyperinsulinism NOS LLT
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    20.1 10027433 - Metabolism and nutrition disorders 10022484 Insulin hypoglycaemia LLT
    Population Age: Children, Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Ongoing) DK (Completed) BG (Completed) ES (Ongoing)
    Trial results: View results
    EudraCT Number: 2017-004545-24 Sponsor Protocol Number: ZP4207-17103 Start Date*: 2018-12-29
    Sponsor Name:Zealand Pharma A/S
    Full Title: A Randomized Trial in 2 Parts: Double-Blind, Placebo-Controlled, Crossover Part 1 and Open-label Part 2, Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congen...
    Medical condition: Children with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    Population Age: Newborns, Infants and toddlers, Under 18 Gender: Male, Female
    Trial protocol: DE (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2008-003625-16 Sponsor Protocol Number: P071007 Start Date*: 2008-09-10
    Sponsor Name:ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS (AP-HP)
    Full Title: Traitement par Sandostatine LP remplaçant le traitement par Sandostatine SC chez les enfants présentant un hyperinsulinisme congénital résistant au diazoxide.
    Medical condition: Enfant présentant un hyperinsulinisme congénital et sensible à la sandostatine.
    Disease: Version SOC Term Classification Code Term Level
    8.1 10061211 Hyperinsulinisme congénital PT
    Population Age: Children, Under 18 Gender:
    Trial protocol: FR (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2014-005554-20 Sponsor Protocol Number: NL51854.091.14 Start Date*: 2015-08-06
    Sponsor Name:Radboud University Medical Center Nijmegen
    Full Title: Visualizing beta cells in patients with postprandial hyperinsulinemic hypoglycemia after bariatric surgery
    Medical condition: Hyperinsulinaemic hypoglycaemia after Roux-en-Y gastric bypass surgery
    Disease: Version SOC Term Classification Code Term Level
    18.0 10027433 - Metabolism and nutrition disorders 10059035 Postprandial hypoglycaemia LLT
    18.0 10014698 - Endocrine disorders 10018424 Glucose metabolism disorders (incl diabetes mellitus) HLGT
    18.0 10027433 - Metabolism and nutrition disorders 10060378 Hyperinsulinaemia PT
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2015-002692-18 Sponsor Protocol Number: 20150616 Start Date*: 2015-10-29
    Sponsor Name:European Commission
    Full Title: The physiology of glucagon-like peptide-1 receptor expression in patients with endogenous hyperinsulinism: correlation with histopathology
    Medical condition: Congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    18.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    Population Age: Newborns, Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: NL (Not Authorised)
    Trial results: (No results available)
    EudraCT Number: 2015-002847-32 Sponsor Protocol Number: X358602 Start Date*: 2015-11-02
    Sponsor Name:XOMA (US) LLC
    Full Title: A Single-Dose Open-Label Study of XOMA 358 in Subjects with Congenital Hyperinsulinism (HI)
    Medical condition: Hypoglycaemia associated with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    19.0 100000004861 10020644 Hyperinsulinism NOS LLT
    19.0 100000004861 10022484 Insulin hypoglycaemia LLT
    Population Age: Adolescents, Under 18, Adults Gender: Male, Female
    Trial protocol: GB (Completed)
    Trial results: View results
    EudraCT Number: 2021-000508-39 Sponsor Protocol Number: HM-GCG-201 Start Date*: 2021-10-22
    Sponsor Name:Hanmi Pharm. Co., Ltd.
    Full Title: A Phase 2, Multiple Ascending Dose, Open-label, Proof-of-concept Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Efficacy of HM15136 Treatment for 8 Weeks in Subjects Aged ≥2 Year...
    Medical condition: Congenital Hyperinsulinism (CHI)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    23.0 100000004850 10083499 Congenital hyperinsulinemic hypoglycemia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2005-004163-39 Sponsor Protocol Number: HSJD-LIT-05 Start Date*: 2005-11-14
    Sponsor Name:Hospital Sant Joan de Déu
    Full Title: Effects on Endocrine-Metabolic Parameters and Body Composition of the Addition of Low-Dose Pioglitazone to Flutamide-Metformin Therapy in Young Women with Hyperinsulinemic Ovarian Hyperandrogenism ...
    Medical condition: Polycystic Ovary Syndrome includes anovulatory hyperandrogenism, hyperinsulinemia and/or dyslipidemia. Adiponectin and interleukin-6 are adipocytokines that have been related to abdominal fat exces...
    Disease:
    Population Age: Adults Gender: Female
    Trial protocol: ES (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-004547-21 Sponsor Protocol Number: ZP4207-17109 Start Date*: 2018-08-24
    Sponsor Name:Zealand Pharma A/S
    Full Title: A Two-Period, Open-label Trial Evaluating the Efficacy and Safety of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism
    Medical condition: Children with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Completed)
    Trial results: View results
    EudraCT Number: 2017-004546-15 Sponsor Protocol Number: ZP4207-17106 Start Date*: 2018-08-24
    Sponsor Name:Zealand Pharma A/S
    Full Title: An Extension Trial Evaluating the Long-term Safety and Efficacy of Dasiglucagon for the Treatment of Children with Congenital Hyperinsulinism
    Medical condition: Children with congenital hyperinsulinism
    Disease: Version SOC Term Classification Code Term Level
    20.0 10027433 - Metabolism and nutrition disorders 10061211 Hyperinsulinism PT
    Population Age: Infants and toddlers, Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: GB (GB - no longer in EU/EEA) DE (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2020-006127-34 Sponsor Protocol Number: 1.3 Start Date*: 2021-09-17
    Sponsor Name:Verein zur Förderung der Wissenschaft und Forschung an der 1.Med. Abteilung der Krankenanstalt Rudolfstiftung
    Full Title: Empagliflozin as potential treatment option for postprandial hyperinsulinemic hypoglycaemia after bariatric surgery – a pilot study
    Medical condition: Postprandial hyperinsulinemic hypoglycaemia (PHH) typically occurs years after bariatric surgery and one to three hours after a carbohydrate-rich meal. It is caused by rapid gastric emptying of und...
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: AT (Ongoing)
    Trial results: (No results available)
    EudraCT Number: 2017-002704-27 Sponsor Protocol Number: VBP15-004-A4 Start Date*: 2019-07-06
    Sponsor Name:ReveraGen BioPharma, Inc.
    Full Title: A Phase IIb Randomized, Double-blind, Parallel Group, Placebo- and Active-controlled Study with Double-Blind Extension to Assess the Efficacy and Safety of Vamorolone in Ambulant Boys with Duchenne...
    Medical condition: Duchenne muscular dystrophy (DMD)
    Disease: Version SOC Term Classification Code Term Level
    20.0 10010331 - Congenital, familial and genetic disorders 10013801 Duchenne muscular dystrophy PT
    Population Age: Children, Under 18 Gender: Male
    Trial protocol: BE (Completed) SE (Completed) NL (Completed) CZ (Completed) GR (Completed) ES (Completed) GB (GB - no longer in EU/EEA)
    Trial results: View results
    EudraCT Number: 2012-004546-15 Sponsor Protocol Number: 12-PP-12 Start Date*: Information not available in EudraCT
    Sponsor Name:CHU de Nice
    Full Title: Assessment of incidence of adverse events in a naive pediatric population treated with an antipsychotic drug over 12 months follow-up
    Medical condition: severe behavioral disorders in mental retardation, autistic syndromes schizophrenia psychosis
    Disease: Version SOC Term Classification Code Term Level
    16.0 100000004873 10033877 Paranoid type schizophrenia LLT
    Population Age: Children, Adolescents, Under 18 Gender: Male, Female
    Trial protocol: FR (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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