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Lanreotide Autogel Treatment of Patients With Congenital Hyperinsulinism of Infancy
Plain-language guide to NCT01070758: phase 4 interventional trial of Lanreotide, 3 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01070758
- Phase
- phase 4
- Status
- completed
- Start
- 2010-02
- Completion (planned or actual)
- 2015-02
- Participants
- 3 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Congenital Hyperinsulinism
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Lanreotide.
Congenital hyperinsulinism is a genetic disorder characterized by inappropriate insulin secretion resulting in persistent hypoglycemia (low blood sugars.
It had 1 arm (groups): Intervention (experimental).
Single arm open label study.
The registry classes the interventions as drug.
More on the Plan
Congenital hyperinsulinism (CH) is a genetic disorder characterized by dysregulated insulin secretion resulting in persistent hypoglycemia.
Many patients are treated with the somatostatin analog Octreotide which is administered by continuous infusion using a pump.
This trial will include children with CH, who are treated with Octreotide by pump.
At this age, some of the parents encounter technical problems with the pump, as the children are prone to play with the pump and take out the needles.
Who Took Part
The registry lists 3 actual participants took part.
It was open to people of any sex aged from 2 years up to 8 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age 2-8 years,. Diagnosed with congenital hyperinsulinism,. Treated by Octreotide continuous infusion (pump).
The full record lists 3 inclusion and 1 exclusion criteria; among the exclusions: family not interested in participating.
How the Study Was Run
The set-up was single-group and open-label.
Nothing was hidden in this open-label Lanreotide study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2010-02 with completion listed for 2015-02.
It ran at 1 site in Israel.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Euglycemia as recorded by Continuous Glucose Monitoring System (CGMS) (time frame: 1 year).
What This Means in Plain Language
Put simply, this is a phase 4 trial of Lanreotide in 3 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Lanreotide compound page, all human trials.
Our Notes on the Compound
Lanreotide: A long-acting 8-amino-acid somatostatin analog (Somatuline Depot) in the same class as octreotide.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.