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Apidra Children & Adolescents Study
Plain-language guide to NCT01202474: phase 4 non-randomized trial of Insulin Glargine, 100 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01202474
- Phase
- phase 4
- Status
- completed
- Start
- 2011-05
- Completion (planned or actual)
- 2012-10
- Participants
- 100 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Type 1
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Insulin Glargine.
It had 1 arm (groups): insulin glulisine and insulin glargine (experimental).
Insulin glulisine and insulin glargine basal/bolus regimen in accordance with the summary of product characteristics and titrated to Plasma glucose target as defined by American Diabetes Association (ADA) recommendations age-specific goals (12).
The registry classes the interventions as drug.
Who Took Part
The registry lists 100 actual participants took part.
It was open to people of any sex aged from 6 years up to 17 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: ChildrenAdolescents with Type 1 diabetes Mellitus l(T1DM) onger than 1 year duration. Age 6 -17 y.o. Treated with insulin glargine and any rapid insulin. Ability to perform a self blood-glucose monitoring (SBGM). Signed Informed consent.
The full record lists 6 inclusion and 7 exclusion criteria; among the exclusions: diabetes mellitus type 2; childrenadolescents with type 1 diabetes mellitus previously treated with apidra; hypersensitivity to insulin glulisine.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
Being open-label, the Insulin Glargine study did not mask who received what.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2011-05 with completion listed for 2012-10.
It ran at 1 site in Russia.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 3 secondary outcomes, for example Change in HbA1c plasma level and Monthly rate of hypoglycaemia.
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of Insulin Glargine in 100 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Glargine compound page, all human trials.
Our Notes on the Compound
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
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.