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Safety and Efficacy of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart as Mealtime Insulin in Type 1 Diabetes
Plain-language guide to NCT00095082: phase 3 randomized trial of Insulin Glargine and Insulin Aspart, 447 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00095082
- Phase
- phase 3
- Status
- completed
- Start
- 2004-09
- Completion (planned or actual)
- 2005-12
- Participants
- 447 (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 Glargine and Insulin Aspart.
This trial is conducted in Europe and the United States of America (USA).
The registry classes the interventions as drug.
Who Took Part
Enrollment: 447 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 for at least 12 months. Current treatment with basal-bolus insulin regimen for more than or equal to 3 months.
The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: proliferative retinopathy or maculopathy; recurrent major hypoglycaemia; impaired hepatic or renal function.
How the Study Was Run
The set-up was randomized, parallel-group and open-label.
Because people in this Insulin Glargine study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.
The Insulin Glargine group and the comparison group ran side by side rather than switching.
Being open-label, the Insulin Glargine study did not mask who received what.
It started in 2004-09 with completion listed for 2005-12.
It ran at 81 sites in United States (28), Germany (17), United Kingdom (12), France (7), Netherlands (6) and Sweden (6).
Its stated primary purpose is treatment.
What Was Measured
The main thing measured (primary outcome): HbA1c (time frame: after 1 year trial period).
It also tracked 5 secondary outcomes, for example Adverse events, Body weight, Hypoglycemia, Blood glucose and Insulin Treatment Satisfaction.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 447 people.
The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.
More context: the Insulin Glargine compound page and the Insulin Aspart compound page, all human trials.
Our Notes on the Compounds
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
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.
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.