Table 4.
Ongoing randomized outcome trials with sodium-glucose cotransporter type 2 inhibitors in type 2 diabetes (updated on June 7, 2016)
| Agent and Trial Name (Clinicaltrials.gov) | N | Key Inclusion Criteria | Main CV End Points | Main Renal End Points | Study Start Date | Estimated Study Completion Date | Expected Follow-Up, yr |
|---|---|---|---|---|---|---|---|
| Canagliflozin | |||||||
| CANVAS (NCT01032629) | 4330 | Age >30 yr, HbA1c=7.0%–10.5%, high CV risk or history of CVD | Primary: MACE (CV death, nonfatal MI, nonfatal stroke) | Secondary: Albuminuria progression | 12/2009 | 02/2017 | Up to 8 |
| CANVAS-R (NCT01989754) | 5820 | Age >30 yr, HbA1c=7.0%–10.5%, high CV risk or history of CVD | Secondary: MACE (CV death, nonfatal MI, nonfatal stroke) | Primary: Albuminuria progression; secondary: albuminuria regression, change in eGFR, UACR at last on-treatment visit | 01/2014 | 01/2017 | 3 |
| CREDENCE (NCT02065791) | 4200 | Age >30 yr, HbA1c=6.5%–12.0%, eGFR=30–90 ml/min, UACR=300–5000 mg/g, ACE-i or ARB use | Secondary: CV death, nonfatal MI, nonfatal stroke, hospitalized HF, hospitalized unstable angina | Primary: Composite renal end point (ESRD, doubling of SCr, renal or CV death) | 02/2014 | 02/2019 | 5.5 |
| Dapagliflozin | |||||||
| DECLARE-TIMI 58 (NCT01730534) | 17,276 | Age ≥40 yr, HbA1c not specified, high CV risk | Primary: CV death, MI or ischemic stroke; secondary: CV death, MI, ischemic stroke, hospitalized HF, hospitalized unstable angina, hospitalized for any revascularization | Not specified | 04/2013 | 04/2019 | Up to 6 |
| Ertugliflozin | |||||||
| VERTIS (NCT01986881) | 3900 | Age ≥40 yr, HbA1c=7.0%–10.5%, evidence or history of atherosclerosis | Primary: CV death, nonfatal MI, nonfatal stroke; secondary: hospitalized unstable angina | Not specified | 11/2013 | 06/2020 | Up to 6.3 |
CV, cardiovascular; CANVAS, Canagliflozin Cardiovascular Assessment Study; HbA1c, hemoglobin A1c; CVD, cardiovascular disease; MACE, major adverse cardiovascular event; MI, myocardial infarction; CANVAS-R, Canagliflozin Cardiovascular Assessment Study–Renal; UACR, urinary albumin-to-creatinine ratio; CREDENCE, Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation; ACE-i, angiotensin-converting enzyme inhibitor; ARB, angiotensin receptor blocker; HF, heart failure; SCr, serum creatinine; DECLARE-TIMI 58, Dapagliflozin Effect on Cardiovascular Events; VERTIS, Cardiovascular Outcomes Following Ertugliflozin Treatment in Type 2 Diabetes Mellitus Participants with Vascular Disease, The VERTIS CV Study.