Glycemia Trial: Intensive Control vs Glycemia Trial: Standard Control: First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
Measures 6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note | Source |
|---|---|---|---|---|---|---|
| Risk in group 1 | 0.0981 | 0.0902 | 0.107 | wilson | ClinicalTrials.gov | |
| Risk in group 2 | 0.106 | 0.0979 | 0.115 | wilson | ClinicalTrials.gov | |
| Risk difference, group 1 minus group 2 | -0.0079 | -0.0196 | 0.00382 | newcombe hybrid score | ClinicalTrials.gov | |
| Risk ratio, group 1 over group 2 | 0.925 | 0.825 | 1.04 | log | ClinicalTrials.gov | |
| Odds ratio, group 1 over group 2 | 0.917 | 0.807 | 1.04 | log | ClinicalTrials.gov | |
| Number needed to treat, for one fewer participant with the outcome on Glycemia Trial: Intensive Control than on Glycemia Trial: Standard Control | 127 | from the risk difference interval | the interval includes no difference | ClinicalTrials.gov |
Groups 2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code | Source |
|---|---|---|---|---|---|---|
| Group 1 | Glycemia Trial: Intensive Control | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels \<6.0%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. | 503 | 5,128 | OG000 | ClinicalTrials.gov |
| Group 2 | Glycemia Trial: Standard Control | Open label administration of oral anti-hyperglycemic agents and/or insulin in combination with dietary/lifestyle advice as needed to achieve glycated hemoglobin (HbA1c) levels of 7.0 to 7.9%. Anti-hyperglycemic agents include multiple drugs including insulins and oral anti-hyperglycemic agents as needed to reach Glycemia Trial arm-specific goals. | 543 | 5,123 | OG001 | ClinicalTrials.gov |
Outcome 5
| Field | Value | Source |
|---|---|---|
| Type | PRIMARY | ClinicalTrials.gov |
| Title | First Occurrence of a Major Cardiovascular Event (MCE); Specifically Nonfatal Heart Attack, Nonfatal Stroke, or Cardiovascular Death (Measured Throughout the Study) in the Glycemia Trial. | ClinicalTrials.gov |
| Description | Time to first occurrence of nonfatal myocardial infarction, nonfatal stroke, or cardiovascular death. This was the primary outcome measure in all three trials: Glycemia (all participants), Blood Pressure (subgroup of participants not in Lipid Trial), and Lipid (subgroup of participants not in Blood Pressure Trial).~In the Glycemia Trial, a finding of higher mortality in the intensive arm group led to an early discontinuation of therapy after a mean of 3.5 years of follow-up. Intensive arm participants were transitioned to standard arm strategy over a period of 0.2 year and followed for an additional 1.2 years to the planned end of the Glycemia Trial while participating in one of the other sub-trials (BP or Lipid) to their planned completion. | ClinicalTrials.gov |
| Time frame | 4.9 years | ClinicalTrials.gov |
| Population | The population analyzed included all participants randomized and was performed by intention to treat with right-censoring of participants who did not complete follow-up prior to occurrence of MCE. | ClinicalTrials.gov |
Trial 8
| Field | Value | Source |
|---|---|---|
| Title | Action to Control Cardiovascular Risk in Diabetes (ACCORD) | ClinicalTrials.gov |
| NCT number | NCT00000620 | ClinicalTrials.gov |
| Phases | PHASE3 | ClinicalTrials.gov |
| Conditions | Atherosclerosis, Cardiovascular Diseases, Hypercholesterolemia, Hypertension, Diabetes Mellitus, Type 2, Diabetes Mellitus, Coronary Disease | ClinicalTrials.gov |
| Interventions | Anti-hyperglycemic Agents, Anti-hypertensive Agents, Blinded fenofibrate or placebo plus simvastatin | ClinicalTrials.gov |
| Lead sponsor | National Heart, Lung, and Blood Institute (NHLBI) | ClinicalTrials.gov |
| Results first posted | 2014-09-15 | ClinicalTrials.gov |
| Results on ClinicalTrials.gov | https://clinicaltrials.gov/study/NCT00000620?tab=results | ClinicalTrials.gov |
Source 4
| Field | Value | Source |
|---|---|---|
| Release | trial-comparisons-2026-03-23-0.1.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57 | ClinicalTrials.gov |
| AACT copy | 2026-03-23 | ClinicalTrials.gov |
| Tables read | outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet | ClinicalTrials.gov |
Release trial-comparisons-2026-03-23-0.1.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.