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Action to Control Cardiovascular Risk in Diabetes (ACCORD)
Plain-language guide to NCT00000620: phase 3 randomized trial of Insulin Glargine and Insulin Aspart, atherosclerosis, cardiovascular disease & high blood pressure, 10251 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT00000620
- Phase
- phase 3
- Status
- completed
- Start
- 1999-09
- Completion (planned or actual)
- 2009-06
- Participants
- 10251 (actual)
- Design
- randomized, open label (everyone knows who gets what), prevention
- Conditions studied
- Atherosclerosis; Cardiovascular Diseases; Hypercholesterolemia; Hypertension; Diabetes Mellitus, Type 2; Diabetes Mellitus
- Results posted
- yes
What This Study Did, in Plain Language
What Was Tested
The trial (phase 3) is built around Insulin Glargine and Insulin Aspart for atherosclerosis, cardiovascular disease & high blood pressure.
It had six arms (groups): one (experimental), one (active comparator), one (experimental), one (active comparator) and Lipid Trial: fenofibrate (experimental).
The registry classes the interventions as drug.
More on the Plan
The study estimated effects on CVD of that level compared with a level that is usually targeted.
Study participants received all medication and treatments related to the study free of charge.
Individuals who selected for and consented to participate in the ACCORD study continued to see their personal physician for all other health care.
Who Took Part
The registry lists 10251 actual participants took part.
It was open to people of any sex aged from 40 years up to 79 years.
Healthy volunteers were not accepted; participants needed the condition being studied.
The full record lists 4 inclusion and 0 exclusion criteria.
How the Study Was Run
Design: randomized, factorial 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.
Being open-label, the Insulin Glargine study did not mask who received what.
It started in 1999-09 with completion listed for 2009-06.
It ran at 7 sites in United States (6) and Canada (1).
Its stated primary purpose is prevention.
What Was Measured
The main thing measured (primary outcome): First Occurrence of Major Cardiovascular Event (MCE) in the Lipid Trial (time frame: 4.7 years).
What This Means in Plain Language
Put simply, this is a phase 3, randomized trial of Insulin Glargine and Insulin Aspart in 10251 people with atherosclerosis, cardiovascular disease & high blood pressure.
With 10251 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 and the Insulin Aspart compound page, Atherosclerosis, cardiovascular disease & high blood pressure research.
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
- Atherosclerosis, cardiovascular disease & high blood pressure research
- Insulin Glargine in the library
- Insulin Aspart in the library
- Insulin Detemir in the library
- NPH Insulin (isophane) in the library
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.