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Comparison of Insulin Detemir Plus Insulin Aspart Against Insulin Glargine Plus Insulin Aspart in Type 2 Diabetes
Plain-language guide to NCT00097084: phase 3 randomized trial of Insulin Glargine and Insulin Aspart, 324 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00097084
- Phase
- phase 3
- Status
- completed
- Start
- 2004-09
- Completion (planned or actual)
- 2005-12
- Participants
- 324 (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
In this phase 3 trial, researchers set out to test 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
The registry lists 324 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. Treated with oral antidiabetic drugs or with any insulin regimen with or without oral antidiabetic drugs. BMI of maximum 40 kg/m2.
The full record lists 4 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.
Groups ran in parallel: each of the participants stayed in one arm throughout.
Everyone knew when Insulin Glargine was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
It started in 2004-09 with completion listed for 2005-12.
It ran at 60 sites in United States (28), Sweden (10), France (9), Finland (7) and Norway (6).
Its stated primary purpose is treatment.
What Was 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 324 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.