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Safety and Efficacy of Insulin Aspart in Subjects With Type 1 Diabetes
Plain-language guide to NCT01707134: phase 3 randomized trial of Insulin (regular human) and Insulin Aspart, 753 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01707134
- Phase
- phase 3
- Status
- completed
- Start
- 1997-09
- Completion (planned or actual)
- 2000-05
- Participants
- 753 (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
This registered phase 3 trial tested Insulin (regular human) and Insulin Aspart.
This trial is conducted in Europe.
The aim of this trial is to evaluate the safety profile of insulin aspart in subjects with type 1 diabetes having participated in trial ANA/DCD/035.
It had two arms (groups): insulin aspart (experimental) and human insulin (active comparator).
The registry classes the interventions as drug.
Who Took Part
The registry lists 753 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: The subject must have completed the six month controlled treatment period in trial ANA/DCD/035.
The full record lists 1 inclusion and 0 exclusion criteria.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Being open-label, the Insulin (regular human) study did not mask who received what.
It started in 1997-09 with completion listed for 2000-05.
It ran at 80 sites in United Kingdom (32), Germany (28), Denmark (5), Norway (5), Finland (4) and Austria (3).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Number of hypoglycaemic events.
It also tracked 4 secondary outcomes, for example Occurrence of adverse events, Incidence of hypoglycaemic episodes, Standard safety parameters: Haematology and biochemistry and HbA1c (glycosylated haemoglobin).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin (regular human) and Insulin Aspart in 753 people.
With 753 participants it is a large trial for this field.
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.