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Evaluation of the Glycaemic Control With Insulin Detemir as an add-on to Current Oral Anti-diabetic Drug Treatment in Subjects With Type 2 Diabetes in Korea
Plain-language guide to NCT00455858: phase 4 non-randomized trial of Insulin Detemir, 87 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00455858
- Phase
- phase 4
- Status
- completed
- Start
- 2007-11
- Completion (planned or actual)
- 2008-10
- Participants
- 87 (actual)
- Design
- non-randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 2
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 4) is built around Insulin Detemir.
This trial is conducted in Asia.
This trial aims for evaluating the glycaemic control, measured as glycosylated haemoglobin (Hb1Ac), of once daily insulin detemir as an add-on to oral antidiabetic drug (OAD) in subjects with type 2 diabetes mellitus in Korea.
It had 1 arm (groups): insulin detemir (active comparator).
The registry classes the interventions as drug.
Who Took Part
87 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 2 diabetes (diagnosed more than 12 months ago). Currently on any OAD in more than 3 months ago. BMI (Body Mass Index) less than 35kg/m2.
The full record lists 4 inclusion and 2 exclusion criteria; among the exclusions: previous treatment with insulin in more than 7 days within the last 3 months; uncontrolled treated/untreated hypertension (systolic blood pressure greater than 180mmhg and/or diastolic blood pressure less than 110mmhg).
How the Study Was Run
It was run as a non-randomized, single-group and open-label study.
Everyone knew when Insulin Detemir 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 2007-11 with completion listed for 2008-10.
It ran at 1 site in South Korea.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 20 (time frame: week 0, week 20).
It also tracked 4 secondary outcomes, for example Change in Glycosylated Haemoglobin A1c (HbA1c) at Week 12 and Change in Fasting Plasma Glucose (FPG).
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of Insulin Detemir in 87 people.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Insulin Detemir compound page, all human trials.
Our Notes on the Compound
Insulin Detemir: A long-acting basal insulin analog sold as Levemir.
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.