Clinical trials: Hyperinsulinemic Hypoglycemia
Hyperinsulinism, Diabetes
Bionic Pancreas in Children With Hyperinsulinism and Post-Pancreatectomy Diabetes
This is a pilot study designed to determine if the bihormonal bionic pancreas provides improved blood glucose control, compared to the current standard of care, in individuals with hyperinsulinism who developed diabetes after…
- Conditions
- Hyperinsulinism, Diabetes, Pancreatic Diseases, Pancreatectomy; Hyperglycemia
- Trial name
- NCT03303196
- Testing
- Bihormonal Bionic Pancreas
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Children's Hospital of Philadelphia
Diabetes
Use of a Hyperinsulinemic-hypyglycemic Clamp to Study Hypoglycemia: a Method Development Study
A hyperinsulinemic-hypoglycemic clamp is an experimental procedure, which allows for hypoglycemia to be studied in a safe and controlled manner.
- Trial name
- NCT03839511
- Testing
- Hyperinsulinemic-hypoglycemic clamp
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Pennington Biomedical Research Center
Congenital Hyperinsulinism
A Two-Period Open-label Trial Evaluating Efficacy and Safety of Dasiglucagon in Children With Congenital Hyperinsulinism
The objective of the trial is to evaluate the efficacy and safety of dasiglucagon administered as a subcutaneous (SC) infusion in reducing hypoglycemia in children with CHI.
- Trial name
- NCT03777176
- Testing
- Dasiglucagon, Standard of Care
- Where
- 10 sites in United States, Germany and 2 more
- Volunteers
- 32 people
- Sponsor
- Zealand Pharma
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
Post Bariatric Hypoglycemia
Efficacy, Tolerability and Pharmacokinetics of Subcutaneous Exendin (9-39) in Patients With Post Bariatric Hypoglycemia
This study is designed to evaluate the efficacy, safety and pharmacokinetics of subcutaneous exendin (9-39) in subjects with post-bariatric hypoglycemia.
- Trial name
- NCT02771574
- Testing
- Lyo avexitide, Liq avexitide
- Where
- United States
- Volunteers
- 19 people
- Sponsor
- Tracey McLaughlin
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
Congenital Hyperinsulinism
Effect of Exendin-(9-39) on Glycemic Control in Subjects With Congenital Hyperinsulinism
The purpose of this study is to determine if Exendin-(9-39), an antagonist of the glucagon-like peptide-1 (GLP-1) receptor with effects on the pancreatic beta cell, increases fasting blood glucose levels in subjects with…
- Trial name
- NCT00571324
- Testing
- Exendin-(9-39), Vehicle
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Diva De Leon
Hyperinsulinism-Hyperammonemia Syndrome
Vitamin E Supplementation in Hyperinsulinism/Hyperammonemia Syndrome
Investigators will assess the tolerability of oral Vitamin E supplementation in subjects with congenital hyperinsulinism (HI) and hyperammonemia (HA) syndrome.
- Trial name
- NCT03797222
- Testing
- Vitamin E
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Elizabeth A Rosenfeld
Congenital Hyperinsulinism
CSI-Glucagon for Prevention of Hypoglycemia in Children With Congenital Hyperinsulinism
This is a Phase 2, multi-center, randomized, placebo-controlled, double-blind trial with open-label follow-up designed to assess the efficacy of Xeris Glucagon delivered as a continuous subcutaneous infusion to prevent…
- Trial name
- NCT02937558
- Testing
- Glucagon
- Where
- 5 sites in United States
- Volunteers
- 5 people
- Sponsor
- Xeris Pharmaceuticals
Congenital Hyperinsulinism (CHI), Persistent Hyperinsulinemic Hypoglycemia of Infancy (PHHI)
Phase II Safety and Efficacy Study of 18FDOPA PET-CT in Children With Hyperinsulinemic Hypoglycemia
Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery to remove part or all of their pancreas.
- Trial name
- 18FDOPA (NCT01468454)
- Testing
- 18 F-DOPA
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- Children's Hospital of Philadelphia
Congenital Hyperinsulinism
Effect of Exendin (9-39) on Glucose Requirements to Maintain Euglycemia
The primary aim of this study is to evaluate the effect of Exendin (9-39) on glucose requirements to maintain euglycemia in pediatric patients with congenital hyperinsulinism (CHI) who have failed medical therapy.
- Trial name
- NCT00835328
- Testing
- Exendin (9-39), Vehicle
- Where
- United States
- Volunteers
- 14 people
- Sponsor
- Diva De Leon
Congenital Hyperinsulinism
Effect of Exendin-(9-39) on Fasting Adaptation and Protein Sensitivity
The purpose of this study is to examine the effects of exendin-(9-39) on fasting blood glucose and protein induced hypoglycemia on subjects with Congenital Hyperinsulinism.
- Trial name
- NCT00897676
- Testing
- Exendin-(9-39)
- Where
- United States
- Volunteers
- 17 people
- Sponsor
- Diva De Leon
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, Hyperinsulinism
Utility of [F-18] fluoroDOPA for Neonatal Hyperinsulinism
Children with congenital hyperinsulinism (CHI) have low blood sugar, and some of these children may require surgery. In this study, researchers affiliated with the University of Pennsylvania will test how well a radioactive drug…
- Conditions
- Congenital Hyperinsulinism, Hyperinsulinism, Persistent Hyperinsulinemic Hypoglycemia of Infancy, CHI
- Trial name
- NCT00674440
- Testing
- F-DOPA, PET scan
- Where
- United States
- Volunteers
- 106 people
- Sponsor
- Children's Hospital of Philadelphia