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Effects of Pulsed Intravenous (IV) Insulin on Brittle and Uncontrolled Diabetes
Plain-language guide to NCT01029444: phase 3 interventional trial of Insulin Aspart, 300 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01029444
- Phase
- phase 3
- Status
- terminated early
- Start
- 2007-03
- Completion (planned or actual)
- 2011-03
- Participants
- 300 (actual)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Insulin Aspart.
Patients are treated once a week with pulsatile intravenous insulin therapy mimicking normal insulin secretion.
Blood sugar diaries and laboratory tests including quarterly Hemoglobin A1c levels are monitored to measure progress and outcomes.
It had 1 arm (groups): Insulin (experimental).
Brittle diabetic patients or patients with uncontrolled blood sugars will complete blood sugar diaries weekly and have hemoglobin A1c lab tests performed quarterly to evaluate progress in stabilizing blood sugars.
The registry classes the interventions as procedure.
More on the Plan
The RQ is determined by the use of a metabolic cart.
Individuals breathe into a mask for 3-5 minutes after a rest period of 30 or more minutes.
The ratio of exhaled volume of CO2 to the inhaled volume of O2 is determined as the RQ.
The physiologic range is 0.7 to1.3.
Who Took Part
300 actual participants took part.
It was open to people of any sex aged from 18 years up to 85 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Taking oral agents and/or insulin for diabetic control. Endocrinologist must assess and approve patient for participation in this study. Ability to swallow without difficulty.
The full record lists 7 inclusion and 6 exclusion criteria; among the exclusions: lack of intravenous access; alcohol abuse, drug addiction or the use of illegal drugs; positive hiv.
How the Study Was Run
It was run as a single-group and open-label study.
Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2007-03 with completion listed for 2011-03.
It ran at 1 site in United States.
Its stated primary purpose is treatment.
What This Means in Plain Language
Put simply, this is a phase 3 trial of Insulin Aspart in 300 people.
It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Aspart compound page, all human trials.
Our Notes on the Compound
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
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.