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Comparison of Insulin Detemir With NPH Insulin in Type 1 Diabetes
Plain-language guide to NCT00184665: phase 3 randomized trial of Insulin Aspart and Insulin Detemir, 501 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00184665
- Phase
- phase 3
- Status
- completed
- Start
- 2004-06
- Completion (planned or actual)
- 2006-09
- Participants
- 501 (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
The trial (phase 3) is built around Insulin Aspart and Insulin Detemir.
This trial is conducted in Africa, Asia, Europe, Oceania, and South America.
The registry classes the interventions as drug.
Who Took Part
The registry lists 501 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 1 diabetes. Currently on basal-bolus regimen. BMI = 35.0 kg/m2.
The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: proliferative retinopathy or maculopathy; recurrent major hypoglycaemia; cardial problems.
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.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Nothing was hidden in this open-label Insulin Aspart study: the participants and staff both knew the treatment.
It started in 2004-06 with completion listed for 2006-09.
It ran at 29 sites in Australia (7), Argentina (4), India (4), South Africa (4), Bulgaria (2) and Malaysia (2).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): HbA1c (time frame: after a two-year trial period).
It also tracked 6 secondary outcomes, for example Adverse events, Body weight, Antibodies, Body composition, 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 501 people.
With 501 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 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.