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Efficacy and Safety of Insulin Detemir in Type 2 Diabetes Inadequately Controlled on OHA Therapy Alone
Plain-language guide to NCT00604253: phase 3 randomized trial of Insulin Detemir and NPH Insulin (isophane), 362 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00604253
- Phase
- phase 3
- Status
- completed
- Start
- 2003-12
- Completion (planned or actual)
- 2005-05
- Participants
- 362 (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 Japan.
The registry classes the interventions as drug.
Who Took Part
The registry lists 362 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 type 2 diabetes mellitus for at least one year. Insulin naive patients. OHA treatment for at least 12 weeks. Body Mass Index (BMI) below 30.0 kg/m2.
The full record lists 5 inclusion and 3 exclusion criteria; among the exclusions: impaired renal function; impaired hepatic function; pregnant, breast-feeding (within a year after delivery), intention of becoming pregnant or not using adequate contraceptive methods.
How the Study Was Run
It was run as a randomized, parallel-group and open-label study.
The participants were allocated by chance, so the Insulin Detemir group and the comparison group should start out alike.
Groups ran in parallel: each of the participants stayed in one arm throughout.
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 2003-12 with completion listed for 2005-05.
It ran at 1 site in Japan.
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: HbA1c (time frame: after 36 weeks of treatment).
It also tracked 4 secondary outcomes, for example Plasma glucose profiles, Incidence of hypoglycaemic episodes, Adverse events 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 362 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.