← Human Trials & Peer-Reviewed Studies
Examining the Long-term Safety of Insulin Aspart When Used as a Part of the Treatment for Type 1 Diabetes
Plain-language guide to NCT00832182: phase 3 non-randomized trial of Insulin Aspart and NPH Insulin (isophane), 75 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00832182
- Phase
- phase 3
- Status
- completed
- Start
- 1999-12-22
- Completion (planned or actual)
- 2002-11-25
- Participants
- 75 (actual)
- Design
- non-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 3 trial, researchers set out to test Insulin Aspart and NPH Insulin (isophane).
This trial is conducted in Europe and Asia.
The aim of this clinical trial is to investigate the long-term safety of insulin aspart in the management of type 1 diabetes.
An extension to the ANA/DCD/065 trial.
It had 1 arm (groups): Insulin aspart and neutral protamine Hagedorn insulin (experimental).
The registry classes the interventions as drug.
Who Took Part
75 actual participants took part.
It was open to people of any sex aged from 18 years up to 70 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Signed informed consent obtained before any trial-related activities. (Trial-related activities are any procedure that would not have been performed during normal management of the subject). The subject must have completed the ANA/DCD/065 trial.
The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: impaired hepatic function; impaired renal function; cardiac problems.
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 1999-12-22 with completion listed for 2002-11-25.
It ran at 10 sites in Russia (5), Czechia (2), Croatia (1), Israel (1) and Slovenia (1).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Number of hypoglycemic episodes and adverse events (time frame: at 3 and 6 months and at the end of the trial).
It also tracked 2 secondary outcomes, for example HbA1c and 9-point blood glucose profile.
What This Means in Plain Language
Put simply, this is a phase 3, non-randomized trial of Insulin Aspart and NPH Insulin (isophane) in 75 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 and the NPH Insulin (isophane) compound page, all human trials.
Our Notes on the Compounds
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
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.