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The ORIGIN Trial (Outcome Reduction With Initial Glargine Intervention)
Plain-language guide to NCT00069784: phase 3 randomized trial of Insulin Glargine, 12537 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00069784
- Phase
- phase 3
- Status
- completed
- Start
- 2003-08
- Completion (planned or actual)
- 2011-12
- Participants
- 12537 (actual)
- Design
- randomized, open label (everyone knows who gets what), treatment
- Conditions studied
- Diabetes Mellitus, Non-Insulin-Dependent
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
In this phase 3 trial, researchers set out to test Insulin Glargine.
It had four arms (groups): Insulin glargine + omega-3 polyunsaturated fatty acids (experimental), Insulin glargine + placebo (experimental), Standard care + omega-3 polyunsaturated fatty acids (experimental) and Standard care + placebo (placebo comparator).
• One capsule of omega-3 polyunsaturated fatty acids once daily.
The registry classes the interventions as device and drug.
Who Took Part
The registry lists 12537 actual participants took part.
It was open to people of any sex aged from 50 years with no upper age limit.
Healthy volunteers were not accepted; participants needed the condition being studied.
Examples of who could join: Previous myocardial infarction (MI) (≥ 5 days prior to randomization). Previous stroke (≥ 5 days prior to randomization). Previous coronary, carotid or peripheral arterial revascularization. Left ventricular hypertrophy by electrocardiogram or echocardiogram. Ankle-brachial index \< 0.9.
The full record lists 10 inclusion and 0 exclusion criteria.
How the Study Was Run
It was run as a randomized, factorial and open-label study.
Random assignment meant chance, not the researchers, decided who got Insulin Glargine and who got the comparison, which limits bias.
Being open-label, the Insulin Glargine study did not mask who received what.
It started in 2003-08 with completion listed for 2011-12.
It ran at 40 sites in United States (1), Argentina (1), Australia (1), Austria (1), Belarus (1) and Bermuda (1).
Its stated primary purpose is treatment.
What Was Measured
It also tracked 3 secondary outcomes, for example Total Mortality (All Causes), Composite Diabetic Microvascular Outcome (Kidney or Eye Disease) and Incidence of Development of Type 2 Diabetes Mellitus in Participants With IGT and/or IFG.
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine in 12537 people.
With 12537 participants it is a large trial for this field.
The trial is marked completed; results are posted on the registry, and this page does not restate them.
More context: the Insulin Glargine compound page, all human trials.
Our Notes on the Compound
Insulin Glargine: A long-acting insulin analog given once daily; brands include Lantus, Toujeo, Basaglar and Semglee.
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.