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Safety and Efficacy of Insulin Detemir in Combination With OAD in Type 2 Diabetes
Plain-language guide to NCT00604396: phase 3 randomized trial of Insulin Detemir and NPH Insulin (isophane), 477 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00604396
- Phase
- phase 3
- Status
- completed
- Start
- 2003-03
- Completion (planned or actual)
- 2004-01
- Participants
- 477 (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
This registered phase 3 trial tested Insulin Detemir and NPH Insulin (isophane).
This trial is conducted in Europe.
The registry classes the interventions as drug.
Who Took Part
The registry lists 477 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 for at least 12 months since diagnosis. Insulin naive subjects. OAD treatment for at least 4 months alone or combined with no more than two OADs. Body mass index (BMI) below 35.0 kg/m2. Able and willing to use twice a day injections for the entire trial period.
The full record lists 6 inclusion and 6 exclusion criteria; among the exclusions: current or previous treatment with thiazolidiones within the last 6 months; OAD treatment with three or more OADs within the last 6 months; acute insulin treatment for longer than 7 days in a row within the last 6 months.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Because people in this Insulin Detemir study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
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 2003-03 with completion listed for 2004-01.
It ran at 62 sites in Poland (12), France (11), Norway (9), Denmark (8), Sweden (8) and Russia (6).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: HbA1c (time frame: after 26 weeks of treatment).
It also tracked 6 secondary outcomes, for example Fasting plasma glucose, Within-subject variation, Incidence of total hypoglycaemic episodes, Body weight, Incidence of 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 477 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.