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Human Insulin NPH and Insulin Aspart in Type 1 Diabetes
Plain-language guide to NCT00597233: phase 4 randomized trial of Insulin (regular human) and Insulin Aspart, 91 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00597233
- Phase
- phase 4
- Status
- completed
- Start
- 2002-10
- Completion (planned or actual)
- 2002-12
- Participants
- 91 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 1
- 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 Aspart.
This trial is conducted in South America.
This aim of this trial is to evaluate the comparative prandial blood glucose lowering profile in subjects with type 1 diabetes.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 91 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: Type 1 diabetes for at least 12 months. Treatment with insulin NPH. Body Mass Index (BMI) below 30 kg/m2.
The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: treatment with oral antidiabetic drugs (oads).
How the Study Was Run
It was run as a randomized, crossover and open-label study.
The participants were allocated by chance, so the Insulin (regular human) group and the comparison group should start out alike.
In the crossover set-up each of the participants took both Insulin (regular human) and the comparison in turn, acting as their own control.
Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.
It started in 2002-10 with completion listed for 2002-12.
It ran at 1 site in Argentina.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Prandial blood glucose lowering profile (time frame: between 1st and 2nd post prandial hours).
It also tracked 3 secondary outcomes, for example Hypoglycaemic events, Adverse events and Serious adverse events.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Aspart in 91 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 Aspart 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 Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
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
- Insulin (regular human) in the library
- Insulin Aspart in the library
- NPH Insulin (isophane) in the library
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.