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Pharmacokinetics of Insulin Detemir in Subjects With Type 1 Diabetes
Plain-language guide to NCT01542450: phase 1 randomized trial of Insulin Detemir and NPH Insulin (isophane), 23 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT01542450
- Phase
- phase 1
- Status
- completed
- Start
- 2002-08
- Completion (planned or actual)
- 2003-02
- Participants
- 23 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes; Diabetes Mellitus, Type 1
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
This registered phase 1 trial tested Insulin Detemir and NPH Insulin (isophane).
This trial is conducted in Japan.
It had two arms (groups): Treatment period 1 (experimental) and Treatment period 2 (active comparator).
The registry classes the interventions as drug.
Who Took Part
23 actual participants took part.
It was open to people of any sex aged from 20 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 1 diabetes mellitus. Duration of diabetes at least 1 year. Body Mass Index (BMI) maximum 25.0 kg/m\^2.
The full record lists 4 inclusion and 16 exclusion criteria; among the exclusions: recurrent severe hypoglycaemia; proliferative retinopathy or maculopathy requiring acute treatment as judged by the investigator; impaired hepatic function.
How the Study Was Run
Design: randomized, crossover and open-label.
Random assignment meant chance, not the researchers, decided who got Insulin Detemir and who got the comparison, which limits bias.
In the crossover set-up each of the participants took both Insulin Detemir and the comparison in turn, acting as their own control.
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 2002-08 with completion listed for 2003-02.
It ran at 1 site in Japan.
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: The ratio of area under the glucose infusion rate curve (AUCGIR) 0-5 hours to AUCGIR 0-24 hours.
It also tracked 9 secondary outcomes, for example AUCGIR, area under the glucose infusion rate value curve, GIRmax, the maximum GIR value, tmax GIR, time to maximum GIR value, Cmax, maximum concentration, Area under the curve and tmax, time to maximum concentration.
What This Means in Plain Language
Put simply, this is a phase 1, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 23 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 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.