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The Effect of Insulin Detemir on Blood Glucose Control in Taiwanese Patients With Type 2 Diabetes Failing on OAD
Plain-language guide to NCT00521690: phase 4 non-randomized trial of Insulin Detemir, 25 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00521690
- Phase
- phase 4
- Status
- completed
- Start
- 2006-12
- Completion (planned or actual)
- 2007-08
- Participants
- 25 (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 Detemir.
The trial is conducted in Asia.
The aim of the trial is to evaluate the effect of insulin detemir on blood glucose control in Taiwanese patients with type 2 diabetes failing on OAD with/without once-daily NPH Insulin treatment.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 25 actual participants took part.
It was open to people of any sex aged from 30 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. Previous diabetes treatment for at least 6 months. BMI max. 35 kg/m2. Treatment with an oral anti-diabetic drug (OAD).
The full record lists 5 inclusion and 2 exclusion criteria; among the exclusions: type 1 diabetes; receipt of any investigational drug within the last three months prior to this trial.
How the Study Was Run
The set-up was non-randomized, single-group and open-label.
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 2006-12 with completion listed for 2007-08.
It ran at 1 site in Taiwan.
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): Incidence of serious adverse events, including major hypoglycaemic events (time frame: during 16 weeks of insulin detemir therapy).
It also tracked 4 secondary outcomes, for example Change in HbA1C, Change in weight, Change in fasting plasma glucose (FPG) and Incidence of hypoglycaemic episodes.
What This Means in Plain Language
Put simply, this is a phase 4, non-randomized trial of Insulin Detemir in 25 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 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.