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The Management of Glucocorticoid-Induced Hyperglycemia in Hospitalized Patients
Plain-language guide to NCT01810952: phase 4 randomized trial of Insulin Glargine and Insulin Lispro, 37 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01810952
- Phase
- phase 4
- Status
- completed
- Start
- 2010-09
- Completion (planned or actual)
- 2013-09
- Participants
- 37 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Hyperglycemia; Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Insulin Glargine and Insulin Lispro.
It had two arms (groups): Glargine/Lispro Insulin Arm (experimental) and Glargine/Lispro/NPH Insulin Arm (experimental).
The registry classes the interventions as drug.
More on the Plan
The patient was still randomly assigned to either one of the two protocols as described previously.
The patient was randomly assigned to either one of the two protocols based upon even and odd hospital numbers.
Who Took Part
37 actual participants took part.
It was open to people of any sex aged from 18 years up to 80 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Admission for Chronic Obstructive Pulmonary Disease (COPD) exacerbation.
The full record lists 4 inclusion and 0 exclusion criteria.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Insulin Glargine study did not mask who received what.
It started in 2010-09 with completion listed for 2013-09.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: Average Daily Glucose Levels on Days 1-5 After the Initiation of the Treatment Protocol (time frame: 1-5 days).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin Glargine and Insulin Lispro in 37 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Insulin Glargine compound page and the Insulin Lispro 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.
Insulin Lispro: A rapid-acting mealtime insulin analog; brands include Humalog, Admelog and Lyumjev.
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.