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Intermediate and Long Acting Insulin Young Children Type 1 Diabetes.
Plain-language guide to NCT04664764: phase 4 randomized trial of Insulin Glargine and NPH Insulin (isophane), 60 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04664764
- Phase
- phase 4
- Status
- status unknown
- Start
- 2019-02-21
- Completion (planned or actual)
- 2021-02-28
- Participants
- 60 (estimated)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 1 Diabetes Mellitus With Hypoglycemia; type1diabetes
- 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 and NPH Insulin (isophane).
Background: Achieving glycemic control without risking hypoglycemia imposes a major challenge in the management of toddlers and preschool children with Type 1 diabetes(T1D).
Despite the advantages of the basal-bolus insulin regimens, hypoglycemia still presents a major barrier in achieving desirable glycemic control.
It had three arms (groups): degludec arm (active comparator), glargine arm (active comparator) and NPH group (active comparator).
Group A received insulin degludec,.
Group B received insulin glargine.
Group C received NPH insulin.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 60 planned participants were the target.
It was open to people of any sex aged from 2 years up to 5 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Toddlers and preschool children with T1D on insulin therapy.
The full record lists 1 inclusion and 1 exclusion criteria.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.
The Insulin Glargine group and the comparison group ran side by side rather than switching.
Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2019-02-21 with completion listed for 2021-02-28.
It ran at 1 site in Egypt.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine and NPH Insulin (isophane) in 60 people.
Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Glargine compound page and the NPH Insulin (isophane) compound page, all human trials.
Our Notes on the Compounds
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
NPH Insulin (isophane): An intermediate-acting insulin made by combining insulin with protamine; also called isophane or NPH insulin (Humulin N, Novolin N).
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.