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Trial · Interventional

CompletedPhase 4Registry data

Lanreotide Autogel Treatment of Patients With Congenital Hyperinsulinism of Infancy

NCTNCT01070758 (opens ClinicalTrials.gov in a new tab)Other idSHEBA-10-7165-DM-CTIL
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 4
Enrollment
3 participants (actual)
Sponsor
Sheba Medical Center · Other gov
Design
Allocation not applicable · Open label (no masking)
Countries
1 country

Israel

Start
Feb 2010
Primary completion
Feb 2015
Completion
Feb 2015
First posted
18 Feb 2010 (estimated)
Last update posted
18 Apr 2024
Conditions
Congenital Hyperinsulinism

Timeline

1 trial · 1 completed

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2010201120122013201420152016
  1. Ph 4

    Lanreotide Autogel Treatment of Patients With Congenital Hyperinsulinism of Infancy

    NCT01070758

    Feb 2010 to Feb 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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

Interventions

  • Lanreotide autogelDrug

Arms1

  • Experimental

    Intervention

    Single arm open label study

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Euglycemia as recorded by Continuous Glucose Monitoring System (CGMS)

    Time frame · 1 year

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Clinical trial · 2011

Treatment of congenital hyperinsulinism with lanreotide acetate (Somatuline Autogel).

Modan-Moses et al. 2011The Journal of clinical endocrinology and metabolismcited by 40

PMID 21697252DOI 10.1210/jc.2011-0605PUB-21697252

Rights unknown
Source link

Eligibility

Who could join, as posted.

Sex
All
Age
from 2 Years up to 8 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Age 2-8 years, * Diagnosed with congenital hyperinsulinism, * Treated by Octreotide continuous infusion (pump). Exclusion Criteria: * Family not interested in participating.

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