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A Study of the Treatment of Type 2 Diabetes With an Insulin Infusion Pump
Plain-language guide to NCT00115973: phase 1 randomized trial of Insulin Aspart, 71 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00115973
- Phase
- phase 1
- Status
- completed
- Start
- 2005-06
- Completion (planned or actual)
- 2006-01
- Participants
- 71 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2; Delivery Systems
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 1 trial, researchers set out to test Insulin Aspart.
This trial is conducted in the United States of America (USA).
A telephone contact visit is scheduled as a follow-up for the final clinic visit.
The registry classes the interventions as device and drug.
Who Took Part
Enrollment: 71 actual participants took part.
It was open to people of any sex aged from 30 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 diabetes diagnosis at least 2 years ago. Body Mass Index (BMI): 26-40 kg/m\^2 (both inclusive).
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: current addiction to alcohol or substances of abuse or positive results on urine screen for drug and alcohol use; known or suspected allergy to trial products or related products.
How the Study Was Run
Design: randomized, crossover and open-label.
The participants were allocated by chance, so the Insulin Aspart group and the comparison group should start out alike.
Each person switched between Insulin Aspart and the comparison at some point, usually with a gap in between.
Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.
It started in 2005-06 with completion listed for 2006-01.
It ran at 6 sites in United States (6).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: HbA1c (time frame: after 3 months).
It also tracked 3 secondary outcomes, for example Fasting plasma glucose, Plasma glucose profiles and Frequency of hypoglycemic events.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Insulin Aspart in 71 people.
The trial is marked completed; 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.