Clinical trials: Hyperinsulinemic Hypoglycemia
Acquired Hyperinsulinemic Hypoglycemia
Avexitide Safety and Efficacy to Treat Acquired Hyperinsulinemic Hypoglycemia
The primary goal of this study is to evaluate the safety and efficacy of two different dosing regimens of an investigational drug called Avexitide in treating low blood sugar in patients with Acquired Hyperinsulinemic…
- Trial name
- NCT04652479
- Testing
- Avexitide
- Where
- United States
- Volunteers
- 25 people
- Sponsor
- Dr. Tracey McLaughlin, MD
Roux-en-y Gastric Bypass, Post Prandial Hypoglycemia
Evaluation of the Neuro-endocrine Response to Post-prandial Hyperinsulinaemic Hypoglycaemia.
The primary objective of this study is to assess the neuro-endocrine response to hypoglycaemia in PHH vs. non-PHH post-gastric bypass individuals.
- Trial name
- DEEP1B (NCT04334161)
- Testing
- Administration of glucose and controlled induction of hypoglycaemia.
- Where
- Switzerland
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Lia Bally
Hyperinsulinism, Hypoglycemia Neonatal
Continuous Glucose Monitoring in Neonatal Hyperinsulinism
The investigators are studying the accuracy of Dexcom G6 continuous glucose monitors placed on babies with hyperinsulinism in the Miller Children's Hospital Neonatal Intensive Care Unit.
- Trial name
- NCT06363929
- Testing
- Dexcom G6 continuous glucose monitor
- Where
- United States
- Volunteers
- 1 people, healthy volunteers welcome
- Sponsor
- MemorialCare Health System
Congenital Hyperinsulinism
GLP-1 Receptor Expression in CHI
The primary objective is the in vivo and ex vivo investigation of the expression and distribution of the GLP-1R in the pancreas of CHI patients.
- Trial name
- GLP-1-CHI (NCT03768518)
- Testing
- 68Ga-exendin-4 PET/CT
- Where
- Netherlands
- Volunteers
- 40 people
- Sponsor
- Radboud University Medical Center
Congenital Hyperinsulinism
Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
The objective of the trial is to evaluate the efficacy of dasiglucagon in reducing glucose requirements in children with persistent congenital hyperinsulinism (CHI) requiring continuous intravenous (IV) glucose administration to…
- Trial name
- NCT04172441
- Testing
- dasiglucagon
- Where
- 6 sites in United States, Germany and 2 more
- Volunteers
- 12 people
- Sponsor
- Zealand Pharma
Congenital Hyperinsulinism
An Open-Label Multiple Dose Study of RZ358 in Patients With Congenital Hyperinsulinism
The objective of this trial is to evaluate the safety, tolerability and glucose-raising effects of RZ358 in patients with Congenital Hyperinsulinism (HI).
- Trial name
- NCT04538989
- Testing
- RZ358 Sequential Group Cohort 1, RZ358 Sequential Group Cohort 2, RZ358 Sequential Group Cohort 3
- Where
- 17 sites in United States, Bulgaria and 9 more
- Volunteers
- 23 people
- Sponsor
- Rezolute
Congenital Hyperinsulinism
RZ358 Treatment for Congenital Hyperinsulinism
The Phase 3 pivotal study is designed to evaluate the efficacy and safety of RZ358 for the treatment of congenital hyperinsulinism (HI) as add-on to standard-of-care (SOC) therapy compared to SOC alone over 24 weeks and to…
- Trial name
- sunRIZE (NCT06208215)
- Testing
- RZ358 (5-10 mg/kg) + SOC
- Where
- 18 sites in United States, Bulgaria and 11 more
- Volunteers
- 56 people
- Sponsor
- Rezolute
Postprandial Hypoglycemia
Empagliflozin for the Treatment of Postprandial Hypoglycemia
This randomized trial is to test whether a treatment with empagliflozin is superior to placebo in patients with postprandial hypoglycemia after bariatric surgery, that is if it improves health related quality of life (mentally or…
- Trial name
- EmpHy (NCT05036317)
- Testing
- Empagliflozin (Jardiance®;
- Where
- 3 sites in Switzerland
- Volunteers
- 40 people
- Sponsor
- University Hospital, Basel, Switzerland
Congenital Hyperinsulinism
HM15136 (Efpegerglucagon) Treatment for 8 Weeks in Subjects Aged ≥2 Years With Congenital Hyperinsulinism (CHI)
This study is designed to evaluate the safety, tolerability, pharmacokinetics (PK), and efficacy of HM15136 when used as add-on therapy in subjects with CHI with persistent hypoglycemia while on standard of care treatment (SoC).
- Trial name
- NCT04732416
- Testing
- HM15136
- Where
- 7 sites in United States, Germany and 3 more
- Volunteers
- 17 people
- Sponsor
- Hanmi Pharmaceutical Company Limited
Hyperinsulinemic Hypoglycemia
Evaluating Exenatide for the Treatment of Postprandial Hyperinsulinemic Hypoglycemia
The purpose of the study is to evaluate the effectiveness of exenatide in adults experiencing episodes of hyperinsulinemic hypoglycemia following Roux-en-Y bariatric surgery.
- Trial name
- NCT02685852
- Testing
- Exenatide, Acarbose
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Minnesota
Hyperinsulinemic Hypoglycemia, Postprandial Hypoglycemia
Treatment of Post-bariatric Hypoglycaemia
This is an investigator-initiated, proof-of-concept, randomised, double-blind, placebo-controlled, single-centre phase II study aiming to evaluate the efficacy, safety and tolerability of self-administered subcutaneous 120 µg…
- Trial name
- SHERRY (NCT04836273)
- Testing
- Dasiglucagon, HyoPen
- Where
- Denmark
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Filip Krag Knop
Glycogen Storage Disease, Congenital Hyperinsulinism (CHI)
Continuous Glucose Monitoring Alerts, Accuracy, and Patient Outcomes in Adults With Inherited Metabolic Disorders
The goal of this clinical trial is to learn if a continuous glucose monitor (CGM) with predictive alerts works better than a CGM with standard alerts to prevent low blood sugar (hypoglycemia) in adults with inherited metabolic…
- Conditions
- Glycogen Storage Disease, Congenital Hyperinsulinism (CHI), Hypoglycemia
- Trial name
- NCT07614139
- Testing
- Continuous glucose monitor with threshold and predictive alerts (Dexcom G7), Continuous glucose monitor with threshold-only alerts (Dexcom ONE+)
- Where
- Italy
- Volunteers
- 11 people
- Sponsor
- University Hospital Padova
Congenital Hyperinsulinaemic Hypoglycaemia, Octreotide Adverse Reaction
Efficacy and Safety Evaluation of Octreotide in the Treatment of Congenital Hyperinsulinemia
To analyze and evaluate the efficacy and safety of octreotide subcutaneous injection in the treatment of diazazine-ineffective congenital hyperinsulinemia (CHI) in children.
- Trial name
- BCH (NCT05171751)
- Testing
- Octreotide Injection
- Where
- China
- Volunteers
- 50 people
- Sponsor
- Beijing Children's Hospital
Congenital Hyperinsulinism, Neuroblastoma
18F-DOPA PET Imaging: an Evaluation of Biodistribution and Safety
Single centre prospective cohort phase III study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients with congenital hyperinsulinism 2. Pediatric patients with neuroblastoma 3.
- Conditions
- Congenital Hyperinsulinism, Neuroblastoma, Neuroendocrine Tumors, Parkinson Disease
- Trial name
- NCT03042416
- Testing
- 18F-DOPA
- Where
- Canada
- Volunteers
- 400 people
- Sponsor
- University of Alberta
Glucose, High Blood, Exercise-Induced Hyperinsulinism
Exercise Type That Faster Reduces Postprandial Glycemia.
It is well established that a bout of 50 min of continuous moderate intensity exercise, improves insulin sensitivity up to 48 hours after the bout.
- Trial name
- GLYEXER (NCT04846751)
- Testing
- TYPE OF EXERCISE (OR REST)
- Where
- Spain
- Volunteers
- 11 people, healthy volunteers welcome
- Sponsor
- University of Castilla-La Mancha
Congenital Hyperinsulinism, Neuroblastoma
18F-DOPA II - PET Imaging Optimization
A single centre non-randomized, non-blinded phase III prospective cohort study of 18F-DOPA PET/CT imaging in specific patient populations: 1. Pediatric patients (less than 18 years old) with congenital hyperinsulinism. 2.
- Conditions
- Congenital Hyperinsulinism, Neuroblastoma, Parkinson Disease, Lewy Body Disease
- Trial name
- NCT04706910
- Testing
- 18F-DOPA, Furosemide Injection
- Where
- Canada
- Volunteers
- 800 people
- Sponsor
- University of Alberta
Hyperinsulinism-Hyperammonemia Syndrome
Vitamin E Efficacy in HI/HA
Congenital hyperinsulinism (HI) is a rare disorder of pancreatic beta cell insulin secretion that causes persistent and severe hypoglycemia starting at birth.
- Trial name
- NCT04984798
- Testing
- Vitamin E
- Where
- United States
- Sponsor
- Children's Hospital of Philadelphia
Seizures, Hypoglycemia
Blood Sugars in Children With Idiopathic Seizures.
The purpose of this study is to determine if there is a significant percentage of children with the diagnosis of idiopathic seizures who have undiagnosed or unrecognized hypoglycemia (low blood sugar).
- Conditions
- Seizures, Hypoglycemia, Hyperammonemia
- Trial name
- NCT00279851
- Where
- United States
- Sponsor
- Children's Mercy Hospital Kansas City
Hyperinsulinemic Hypoglycemia
Glucagon Ready to Use (RTU) in Subjects With Hyperinsulinemic Hypoglycemia After Bariatric Surgery
This is a double-blind, placebo-controlled Phase 2 study to assess the efficacy, safety and tolerability of Glucagon RTU when administered to subjects with a history of bariatric surgery during episodes of post-postprandial…
- Trial name
- NCT03770637
- Testing
- Glucagon RTU
- Where
- 5 sites in United States
- Volunteers
- 14 people
- Sponsor
- Xeris Pharmaceuticals
Congenital Hyperinsulinism (CHI)
Umbilical Cord Glucose
Congenital hyperinsulinism (HI) causes persistent neonatal hypoglycemia that, if untreated, can lead to neurodevelopmental impairments (NDI) such as cognitive delays, cerebral palsy, epilepsy, and blindness.
- Trial name
- Save The Brain (NCT07795047)
- Testing
- For the screening, the interventions will be glucose measurements (and possibly G-BOBH), while follow-up assessments will include Bayley testing, EEG, and MRI.
- Volunteers
- 50 people
- Sponsor
- Odense University Hospital