Lanreotide Autogel Treatment of Patients With Congenital Hyperinsulinism of Infancy

NCT01070758 | Completed Phase 4

• 1 other identifier: SHEBA-10-7165-DM-CTIL
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of our study is to evaluate the efficacy and safety of Lanreotide Autogel in children with congenital hyperinsulinism already treated with Octreotide by pump. Congenital hyperinsulinism is a genetic disorder characterized by inappropriate insulin secretion resulting in persistent hypoglycemia (low blood sugars. Patients exposed to recurrent hypoglycemic episodes are at increased risk of developmental disorders, so identification and prompt management of patients are essential. Many patients are treated with the somatostatin analog Octreotide which is administered by continuous infusion using a pump (we use an insulin pump). This treatment may pose a huge burden and be stressful for patients and families as it demands intensive daily care. In an effort to simplify the daily care of our patients and improve their quality of life we will study the efficacy and safety of Lanreotide Autogel - a long-acting somatostatin analog that can be administered by injection once a month

Conditions

Congenital Hyperinsulinism

Keywords

Congenital hyperinsulinism; Somatostatin analog; Lanreotide autogel; Hypoglycemia

Outcome Measures

Primary Outcomes (1)

• Euglycemia as recorded by Continuous Glucose Monitoring System (CGMS)

  1 year

Study Arms (1)

Intervention

EXPERIMENTAL

Single arm open label study

Drug: Lanreotide autogel

Interventions

Lanreotide autogel DRUG

The dose of Lan-ATG will be calculated according to the surface area of the patient. The dose used in adults is usually 60 mg injection once a month, and we will adapt the patient's dose according to the body surface area and also according to the daily dose of Octreotide used with the pump. The starting dose will be 40 mg/m².

Also known as: Somatuline autogel

Intervention

Eligibility Criteria

• Age: 2 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age 2-8 years,
• Diagnosed with congenital hyperinsulinism,
• Treated by Octreotide continuous infusion (pump).

You may not qualify if:

• Family not interested in participating.

Sponsors & Collaborators

• Sheba Medical Center: lead

Study Sites (1)

Pediatric Endocrinology Unit, Sheba Medical Center

Ramat Gan, 52653, Israel

Location

Related Publications (1)

• Modan-Moses D, Koren I, Mazor-Aronovitch K, Pinhas-Hamiel O, Landau H. Treatment of congenital hyperinsulinism with lanreotide acetate (Somatuline Autogel). J Clin Endocrinol Metab. 2011 Aug;96(8):2312-7. doi: 10.1210/jc.2011-0605. Epub 2011 Jun 22.

  PMID: 21697252 DERIVED

MeSH Terms

Conditions

Congenital Hyperinsulinism; Hypoglycemia

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Infant, Newborn, Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Dalit Modan, M.D.

  Sheba Medical Ceter, Tel-Hashomer, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Endocrinologist

Study Record Dates

• First Submitted: February 17, 2010
• First Posted: February 18, 2010
• Study Start: February 1, 2010
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

IL (1)