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Effect of Insulin Detemir on Blood Glucose Control in Subjects With Type 2 Diabetes
Plain-language guide to NCT00383877: phase 3 randomized trial of Insulin Detemir and NPH Insulin (isophane), 263 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00383877
- Phase
- phase 3
- Status
- completed
- Start
- 2006-09
- Completion (planned or actual)
- 2007-08
- Participants
- 263 (actual)
- Design
- 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
In this phase 3 trial, researchers set out to test Insulin Detemir and NPH Insulin (isophane).
This trial is conducted in China.
This trial aims for a comparison of the effect on glycemic control in subjects with type 2 diabetes of insulin detemir or NPH-insulin given once daily at bedtime as add-on to oral anti-diabetic drug(s).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 263 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. Currently on any oral antidiabetic drug (OAD) more than or equal to 3 months.
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: previous acute treatment with insulin for more than 7 days; treatment with oad(s) which does not adhere to the approval labeling; proliferate retinopathy or maculopathy that has required acute treatment within the last year.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
Random assignment meant chance, not the researchers, decided who got Insulin Detemir and who got the comparison, which limits bias.
The Insulin Detemir group and the comparison group ran side by side rather than switching.
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.
It started in 2006-09 with completion listed for 2007-08.
It ran at 1 site in China.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: HbA1c (time frame: after 20 weeks of treatment).
It also tracked 4 secondary outcomes, for example FBG, Safety profile and Within-subject variation of self measured blood glucose (SMBG) before breakfast during the trial at the end of the trial.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 263 people.
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 and the NPH Insulin (isophane) compound page, all human trials.
Our Notes on the Compounds
Insulin Detemir: A long-acting basal insulin analog sold as Levemir.
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.