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Comparison of Insulin Detemir Morning, Insulin Detemir Evening and NPH Insulin Evening in Patients With Type 2 Diabetes
Plain-language guide to NCT00104182: phase 3 randomized trial of Insulin Detemir and NPH Insulin (isophane), 503 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00104182
- Phase
- phase 3
- Status
- completed
- Start
- 2005-02
- Completion (planned or actual)
- 2006-02
- Participants
- 503 (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
The trial (phase 3) is built around Insulin Detemir and NPH Insulin (isophane).
This trial is conducted in Europe and the United States of America (USA).
The aim of this trial is to compare the use of Insulin Detemir once a day (morning or evening) to NPH Insulin once a day (evening) when added to treatment with oral antidiabetic drugs in patients with Type 2 diabetes.
The registry classes the interventions as drug.
Who Took Part
503 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. Currently treated with Oral Antidiabetic Drugs. BMI lesser than or equal to 40 kg/m2.
The full record lists 4 inclusion and 3 exclusion criteria; among the exclusions: proliferative retinopathy or maculopathy; recurrent major hypoglycaemia.
How the Study Was Run
Design: 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 2005-02 with completion listed for 2006-02.
It ran at 96 sites in United States (29), Spain (17), Denmark (12), Italy (12), France (10) and Norway (9).
Its stated primary purpose is treatment.
What Was Measured
Researchers chose this as the main measure: HbA1C (time frame: after 20 weeks).
It also tracked 4 secondary outcomes, for example Adverse events, body weight, Hypoglycemia and Blood glucose.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Detemir and NPH Insulin (isophane) in 503 people.
With 503 participants it is a large trial for this field.
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.