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Clinical trials for Hyperinsulinemic hypoglycemia

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   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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    8 result(s) found for: Hyperinsulinemic hypoglycemia. Displaying page 1 of 1.
    EudraCT Number: 2018-001569-17 Sponsor Protocol Number: T1DM_IAH_dapa Start Date*: 2018-08-17
    Sponsor Name:Radboud university medical center
    Full Title: Effect of the SGLT-2 inhibitor dapagliflozin on impaired awareness of hypoglycemia in type 1 diabetes
    Medical condition: Type 1 diabetes
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed)
    Trial results: View results
    EudraCT Number: 2014-003167-38 Sponsor Protocol Number: NL50643.09r.r4 Start Date*: 2015-04-28
    Sponsor Name:Radboudumc
    Full Title: 68Ga-NODAGA-exendin-4 PET/CT in patients with AHH - a prospective comparative evaluation of preoperative imaging Under the FP7 project Betacure (602812); Personalized diagnosis and treatment of hy...
    Medical condition: Adult endogenous hyperinsulinemic hypoglycemia
    Disease:
    Population Age: Adults Gender: Male, Female
    Trial protocol: NL (Completed) FI (Completed)
    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 (Completed)
    Trial results: (No results available)
    EudraCT Number: 2020-005241-16 Sponsor Protocol Number: CKN-DASI120-RYGB Start Date*: 2021-03-19
    Sponsor Name:Center for Clinical Metabolic Research at Herlev-Gentofte Hospital
    Full Title: Ready-to-use dasiglucagon for the treatment of postprandial hypoglycaemia in Roux-en-Y gastric bypass operated patients
    Medical condition: Postprandial hyperinsulinemic hypoglycaemia
    Disease: Version SOC Term Classification Code Term Level
    20.1 100000004861 10079748 Reactive hypoglycaemia LLT
    Population Age: Adults Gender: Male, Female
    Trial protocol: DK (Completed)
    Trial results: View results
    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 (Completed) DK (Completed) BG (Completed) ES (Ongoing)
    Trial results: View results
    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: 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: 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 (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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