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Comparison of Insulin Detemir or Insulin Glargine as Add on to Oral Antidiabetic Drugs in Type 2 Diabetes
Plain-language guide to NCT00283751: phase 3 randomized trial of Insulin Glargine and Insulin Detemir, 583 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00283751
- Phase
- phase 3
- Status
- completed
- Start
- 2003-03
- Completion (planned or actual)
- 2004-11
- Participants
- 583 (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
This registered phase 3 trial tested Insulin Glargine and Insulin Detemir.
This trial is conducted in Europe and the United States of America (USA).
The registry classes the interventions as drug.
Who Took Part
583 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 more than 12 months, and no previous insulin treatment. Oral Antidiabetic Drug treatment for at least 4 months. Body Mass Index (BMI) less than 40 kg/m2.
The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: current or previous treatment with thiazolidinediones within the last 6 months; oral antidiabetic drug treatment with combination of three or more oral antidiabetic drugs within the last 6 months; proliferative retinopathy or maculopathy.
How the Study Was Run
Design: 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 2003-03 with completion listed for 2004-11.
It ran at 96 sites in Germany (31), United States (21), United Kingdom (17), France (13), Austria (7) and Belgium (5).
Its stated primary purpose is treatment.
What Was Measured
Primary outcome: HbA1c (time frame: after 52 weeks).
It also tracked 4 secondary outcomes, for example Insulin antibodies, Incident of hypoglycaemic episodes and adverse events, Plasma glucose profiles and Change in body weight.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Detemir in 583 people.
With 583 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 Glargine compound page and the Insulin Detemir 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 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.