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Efficacy and the Safety of Insulin Detemir in Subjects With Insulin Requiring Diabetes
Plain-language guide to NCT00604344: phase 3 randomized trial of Insulin Detemir and NPH Insulin (isophane), 401 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00604344
- Phase
- phase 3
- Status
- completed
- Start
- 2003-04
- Completion (planned or actual)
- 2005-03
- Participants
- 401 (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 3 trial tested Insulin Detemir and NPH Insulin (isophane).
This trial is conducted in Japan.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 401 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: Duration of diabetes mellitus for at least 2 years. Current treatment of basal-bolus regimen for at least 12 weeks using an intermediate/long-acting human insulin and insulin aspart.
The full record lists 3 inclusion and 8 exclusion criteria; among the exclusions: impaired renal function; impaired hepatic function; serious heart diseases.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
The participants were allocated by chance, so the Insulin Detemir group and the comparison group should start out alike.
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 2003-04 with completion listed for 2005-03.
It ran at 1 site in Japan.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: HbA1c (time frame: after 48 weeks of treatment).
It also tracked 5 secondary outcomes, for example Blood glucose profiles, Hypoglycaemic episodes, Adverse events, Body weight and Insulin antibodies.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 401 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.