← Human Trials & Peer-Reviewed Studies
Efficacy and Safety of Insulin Aspart in Subjects With Type 1 or Type 2 Diabetes
Plain-language guide to NCT00593255: phase 4 randomized trial of Insulin (regular human) and Insulin Aspart, 220 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00593255
- Phase
- phase 4
- Status
- completed
- Start
- 2004-07
- Completion (planned or actual)
- 2005-04
- Participants
- 220 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin (regular human) and Insulin Aspart.
This trial is conducted in Asia.
The registry classes the interventions as drug.
Who Took Part
The registry lists 220 actual participants took part.
It was open to people of any sex aged from 18 years up to 65 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 1 or 2 diabetes for at least 4 weeks. Treatment with oral antidiabetic drugs (OADs) and/or insulin for at least 4 weeks. Body Mass Index (BMI): 18-35 kg/m2.
The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: treatment with either soluble human insulin or insulin nph three times daily within 3 months before trial participation; history of drug abuse or alcohol dependence.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Insulin (regular human) group and the comparison group ran side by side rather than switching.
Nothing was hidden in this open-label Insulin (regular human) study: the participants and staff both knew the treatment.
It started in 2004-07 with completion listed for 2005-04.
It ran at 5 sites in China (5).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: 2-hours postprandial plasma glucose (PPPG) (time frame: after 12 weeks of treatment).
It also tracked 5 secondary outcomes, for example Percentage of subjects achieving 2-hours PPPG treatment target, Percentage of subjects achieving HbA1c treatment target, HbA1c, Fasting plasma glucose and Hypoglycaemic episodes.
What This Means in Plain Language
Put simply, this is a phase 4, randomized trial of Insulin (regular human) and Insulin Aspart in 220 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.