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Self-control Trial to Evaluate the Remission Rate in Newly Diagnosed Type 2 Diabetes Patients After Treatment With Insulin Aspart
Plain-language guide to NCT00494988: phase 4 non-randomized trial of Insulin Aspart and NPH Insulin (isophane), 33 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00494988
- Phase
- phase 4
- Status
- completed
- Start
- 2004-12
- Completion (planned or actual)
- 2006-04
- Participants
- 33 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 4 trial tested Insulin Aspart and NPH Insulin (isophane).
This trial is conducted in Asia.
The aim of this trial is evaluate the remission rate in newly diagnosed subjects with type 2 diabetes after short-term intensive treatment with insulin aspart and insulin NPH.
The registry classes the interventions as drug.
Who Took Part
33 actual participants took part.
It was open to people of any sex aged from 18 years up to 50 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 2 diabetes newly diagnosed within 6-12 months. Body mass index (BMI) larger than 25.0 kg/m2.
The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: known or suspected allergy to trial product(s) or related products; recurrent major hypoglycaemia as judged by the investigator.
How the Study Was Run
The set-up was non-randomized, single-group and open-label.
Everyone knew when Insulin Aspart was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2004-12 with completion listed for 2006-04.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: Remission rate (time frame: after 24 weeks).
It also tracked 2 secondary outcomes, for example blood glucose profiles and HbA1c.
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of Insulin Aspart and NPH Insulin (isophane) in 33 people.
Its size is small, so on its own it can only give an early look.
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.