Cardiovascular Outcome Trials in Diabetes Care
Table 1. Selected trials of GLP-1 agonists.
| Clinical Trial | Drug | Outcomes |
| LEADER | Liraglutide | The trial demonstrated a significant 13% reduction in the primary composite endpoint of MACE (HR 0.87, 95% CI 0.78-0.97, p=0.01), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke. |
| SUSTAIN-6 | Semaglutide | The study showed a significant 26% reduction in the primary composite endpoint of MACE (HR 0.74, 95% CI 0.58-0.95, p=0.02), with a lower rate of cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke compared to the placebo group. |
| ELIXA | Lixisenatide | The trial showed that lixisenatide did not significantly reduce the primary composite endpoint of MACE (HR 1.02, 95% CI 0.89-1.17, p=0.81), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo. |
| PIONEER | Oral semaglutide | The study demonstrated a significant 21% reduction in the primary composite endpoint of MACE (HR 0.79, 95% CI 0.57-1.11, p=0.17), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo. |
| HARMONY | Albiglutide | The trial showed a significant 22% reduction in the primary composite endpoint of MACE (HR 0.78, 95% CI 0.68-0.90, p=0.0006), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo. |
| REWIND | Dulaglutide | The study demonstrated a significant 12% reduction in the primary composite endpoint of MACE (HR 0.88, 95% CI 0.79-0.99, p=0.026), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo. |
| FREEDOM-CVO | Canagliflozin | The trial showed a significant 14% reduction in the primary composite endpoint of MACE (HR 0.86, 95% CI 0.75-0.97, p=0.02), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo. |
Table 2. Selected trials of SGLT-2 inhibitors.
| Clinical Trial | Drug | Outcomes |
| EMPA-REG OUTCOME | Empagliflozin | The trial demonstrated a significant 14% reduction in the primary composite endpoint of MACE (HR 0.86, 95% CI 0.74-0.99, p=0.04), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo. |
| CANVAS | Canagliflozin | The study showed a significant 14% reduction in the primary composite endpoint of MACE (HR 0.86, 95% CI 0.75-0.97, p=0.02), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo. |
| DAPA-HF | Dapagliflozin | The trial demonstrated a significant 26% reduction in the primary composite endpoint of worsening heart failure or cardiovascular death (HR 0.74, 95% CI 0.65-0.85, p<0.001) in patients with heart failure with reduced ejection fraction, when compared to placebo. |
| VERTIS CV | Ertugliflozin | The study showed no significant reduction in the primary composite endpoint of MACE (HR 0.97, 95% CI 0.85-1.11, p=0.70), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo. |
| DECLARE-TIMI 58 | Dapagliflozin | The trial demonstrated a significant 17% reduction in the primary composite endpoint of hospitalization for heart failure or cardiovascular death (HR 0.83, 95% CI 0.73-0.95, p=0.005), but no significant reduction in MACE (HR 0.93, 95% CI 0.84-1.03, p=0.17), when compared to placebo. |
| CREDENCE | Canagliflozin | The study showed a significant 30% reduction in the primary composite endpoint of end-stage kidney disease, doubling of serum creatinine, or renal or cardiovascular death (HR 0.70, 95% CI 0.59-0.82, p<0.001), when compared to placebo. |
| EMPEROR-Preserved | Empagliflozin | The trial demonstrated a significant 21% reduction in the primary composite endpoint of cardiovascular death or hospitalization for heart failure (HR 0.79, 95% CI 0.69-0.90, p<0.001) in patients with heart failure with preserved ejection fraction, when compared to placebo. |
| EMPEROR Reduced | Empagliflozin | The study showed a significant 25% reduction in the primary composite endpoint of cardiovascular death or hospitalization for heart failure (HR 0.75, 95% CI 0.65-0.86, p<0.001) in patients with heart failure with reduced ejection fraction, when compared to placebo. |
Table 3. Selected trials of DPP-4 inhibitors.
| Clinical Trial | Drug | Outcomes |
| EXAMINE | Alogliptin | The trial showed no significant reduction in the primary composite endpoint of MACE (HR 0.96, 95% CI 0.81-1.14, p=0.65), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo. |
| SAVOR-TIMI 53 | Saxagliptin | The study demonstrated no significant reduction in the primary composite endpoint of MACE (HR 1.00, 95% CI 0.89-1.12, p=0.99), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo. |
| TECOS | Sitagliptin | The trial showed no significant reduction in the primary composite endpoint of MACE (HR 0.98, 95% CI 0.88-1.09, p=0.65), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo. |
| CARMELINA | Linagliptin | The study demonstrated no significant reduction in the primary composite endpoint of MACE (HR 1.02, 95% CI 0.89-1.17, p=0.73), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo. |
| CAROLINA | Linagliptin vs Glimepiride | The trial showed no significant difference in the primary composite endpoint of MACE (HR 0.98, 95% CI 0.84-1.14, p=0.76), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, between linagliptin and glimepiride. |
Table 4. Other selected clinical trials.
Trending
| Clinical Trial | Drug | Outcomes |
| DEVOTE | Insulin Degludec vs. Insulin Glargine | The trial demonstrated no significant difference in the primary composite endpoint of MACE (HR 0.91, 95% CI 0.78-1.06, p=0.21), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, between insulin degludec and insulin glargine. |
| IRIS | Pioglitazone | The study showed a significant 24% reduction in the primary composite endpoint of fatal or nonfatal stroke or myocardial infarction (HR 0.76, 95% CI 0.62-0.93, p=0.007) in patients with insulin resistance and a recent history of ischemic stroke or transient ischemic attack, when compared to placebo. |
| ACE | Acarbose | The trial demonstrated no significant reduction in the primary composite endpoint of MACE (HR 0.91, 95% CI 0.79-1.06, p=0.21), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, when compared to placebo. |
Table 5. Landmark Diabetes Trials
| Clinical Trial | Drug | Outcomes |
| DCCT | Intensive vs. Conventional Insulin Therapy | The trial demonstrated a significant 42% reduction in the risk of developing retinopathy, nephropathy, and neuropathy (p<0.001) in patients with type 1 diabetes receiving intensive insulin therapy compared to conventional therapy. |
| EDIC | Early intensive insulin therapy | The follow-up study of DCCT showed that the benefits of early intensive insulin therapy persisted, with a significant 57% reduction in the risk of nonfatal myocardial infarction, stroke, or death from cardiovascular disease (HR 0.43, 95% CI 0.25-0.74, p=0.002). |
| UKPDS | Intensive Blood-Glucose Control | The trial demonstrated a significant 12% reduction in the risk of diabetes-related endpoints (HR 0.88, 95% CI 0.79-0.99, p=0.03) and a 25% reduction in the risk of microvascular complications (p=0.0099) in patients with type 2 diabetes receiving intensive blood-glucose control compared to conventional therapy. |
| ACCORD | Intensive vs. Standard Glycemic Control | The study showed no significant reduction in the primary composite endpoint of MACE (HR 0.90, 95% CI 0.78-1.04, p=0.16), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, with intensive glycemic control compared to standard therapy. |
| ADVANCE | Intensive Blood Glucose Control | The trial demonstrated a significant 10% reduction in the primary composite endpoint of major macrovascular and microvascular events (HR 0.90, 95% CI 0.82-0.98, p=0.01) in patients with type 2 diabetes receiving intensive blood glucose control compared to standard therapy. |
| VADT | Intensive vs. Standard Glycemic Control | The study showed no significant reduction in the primary composite endpoint of MACE (HR 0.88, 95% CI 0.74-1.05, p=0.14), including cardiovascular death, nonfatal myocardial infarction, and nonfatal stroke, with intensive glycemic control compared to standard therapy. |
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