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Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management
Plain-language guide to NCT04567225: phase 4 non-randomized trial of Insulin (regular human) and Insulin Glargine, 39 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT04567225
- Phase
- phase 4
- Status
- terminated early
- Start
- 2020-10-01
- Completion (planned or actual)
- 2021-08-27
- Participants
- 39 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetic Ketoacidosis; Type 1 Diabetes; Type 2 Diabetes
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Insulin (regular human) and Insulin Glargine.
Early Basal Insulin Administration in Adult Diabetic Ketoacidosis Management.
It had two arms (groups): Early Glargine (experimental) and Standard practice (Late Glargine) (active comparator).
Retrospective, prespecified and matched sample of consecutive adults who admitted to the same Medical ICU with a diagnosis of DKA in the period between January 1st 2019 till the Institutional Review Board (IRB) approval date and didn't receive basal insulin before Anion Gap closure.
The registry classes the interventions as drug and other.
Who Took Part
The registry lists 39 actual participants took part.
It was open to people of any sex aged from 18 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Age ≥ 18 years old. Having the capacity to sign Informed consent.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
Being open-label, the Insulin (regular human) 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 2020-10-01 with completion listed for 2021-08-27.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Time to Anion Gap Closure (time frame: Participants monitored from hospital admission to discharge, an average of 5 days).
It also tracked 6 secondary outcomes, for example Hospital Length of Stay, ICU Length of Stay, Incidence of Transitional Failure, Incidence of Hyperglycemia and Incidence of Hypoglycemia.
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of Insulin (regular human) and Insulin Glargine in 39 people.
Its size is small, so on its own it can only give an early look.
It ended early (terminated); results are posted on the registry, and this page does not restate them.
More context: the Insulin (regular human) compound page and the Insulin Glargine compound page, all human trials.
Our Notes on the Compounds
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
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.