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Comparison of Efficacy and Safety of Insulin Detemir and NPH Insulin in Children and Adolescents With Type 1 Diabetes
Plain-language guide to NCT00312156: phase 3 randomized trial of Insulin Aspart and Insulin Detemir, 347 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00312156
- Phase
- phase 3
- Status
- completed
- Start
- 2002-08
- Completion (planned or actual)
- 2003-08
- Participants
- 347 (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 Aspart and Insulin Detemir.
The trial is conducted in Europe and Middle East.
The aim of the trial is to compare the use of Insulin Detemir once or twice daily combined with mealtime Insulin Aspart against that of NPH Insulin once or twice daily combined with mealtime Insulin Aspart.
The trial involves children and adolescents with Type 1 Diabetes.
The registry classes the interventions as drug.
Who Took Part
Enrollment: 347 actual participants took part.
It was open to people of any sex aged from 6 years up to 17 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Type 1 diabetes for at least 12 months. Informed consent obtained.
The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: proliferate retinopathy or maculopathy; any condition or disease that rule out trial participation according to the judgement of the investigator; mental incapacity, unwillingness or language barriers precluding understanding or cooperation.
How the Study Was Run
Design: randomized, parallel-group and open-label.
Because people in this Insulin Aspart study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Insulin Aspart group and the comparison group ran side by side rather than switching.
Being open-label, the Insulin Aspart study did not mask who received what.
It started in 2002-08 with completion listed for 2003-08.
It ran at 42 sites in Sweden (6), United Kingdom (5), Denmark (4), France (4), Germany (4) and Norway (4).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: HbA1c (time frame: after 26 weeks).
It also tracked 5 secondary outcomes, for example Adverse events, body weight, Antibodies, Blood glucose and Hypoglycaemia.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Aspart and Insulin Detemir in 347 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Aspart compound page and the Insulin Detemir compound page, all human trials.
Our Notes on the Compounds
Insulin Aspart: A rapid-acting mealtime insulin analog; brands include NovoLog, NovoRapid and Fiasp.
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.