← Human Trials & Peer-Reviewed Studies
Effect of Glycemic Variability on Autonomic Tone in Hospitalized Patients With Type 2 Diabetes
Plain-language guide to NCT01409239: phase 4 randomized trial of Insulin (regular human), 42 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01409239
- Phase
- phase 4
- Status
- completed
- Start
- 2011-07
- Completion (planned or actual)
- 2012-06
- Participants
- 42 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Type 2 Diabetes; Inpatient
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 4 trial, researchers set out to test Insulin (regular human).
However, it is unknown how modulation of glycemic variability would impact outcomes.
One possibility is that glycemic variability could impact autonomic tone.
It had two arms (groups): Subcutaneous Insulin (active comparator) and Intravenous insulin (experimental).
The registry classes the interventions as drug.
Who Took Part
42 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 and above. Admitted to a general medicine or medicine subspecialty service.
The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: type 1 diabetes; hospital stay expected less than 48 hours; inability to consent.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Insulin (regular human) group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.
It started in 2011-07 with completion listed for 2012-06.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Difference Between Heart Rate Variability Between Intravenous and Subcutaneous Group (time frame: 6 hour).
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 42 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Insulin (regular human) compound page, all human trials.
Our Notes on the Compound
Insulin (regular human): The 51-amino-acid pancreatic hormone that lowers blood glucose; this page covers regular (short-acting) insulin studied in human trials.
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.