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Glargine Insulin vs.Continuous Regular Insulin in Diabetic Surgical Patients Receiving Parenteral Nutrition (GLUCOSE-in-PN)
Plain-language guide to NCT02216799: phase 4 randomized trial of Insulin (regular human) and Insulin Glargine, 61 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT02216799
- Phase
- phase 4
- Status
- completed
- Start
- 2013-03
- Completion (planned or actual)
- 2015-08
- Participants
- 61 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetic Patients With Gastrointestinal Cancer Undergoing Surgery and Receiving Parenteral Nutrition
- 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 (regular human) and Insulin Glargine.
Focus on poor glycemic control as a contributor to adverse outcomes in settings outside the intensive care unit (ICU) is often dismissed.
It had two arms (groups): Regular Insulin incorporated in parenteral nutrition (active comparator) and Insulin glargine (active comparator).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 61 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: All adult diabetic patients undergoing abdominal surgery operated by the surgical oncology team at KFSH \& RC and required TPN therapy are possible subjects of the study.
The full record lists 1 inclusion and 3 exclusion criteria; among the exclusions: patients receiving octreotide or immunosuppressive agents including corticosteroids.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.
The Insulin (regular human) group and the comparison group ran side by side rather than switching.
Everyone knew when Insulin (regular human) was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2013-03 with completion listed for 2015-08.
It ran at 1 site in Saudi Arabia.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Achievement of target blood glucose ([amount hidden]/dL to [amount hidden]/dL).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Glargine in 61 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
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.