Table 1.
Characteristics of randomized controlled trials comparing effect of CETP inhibitor (CETPi) to placebo
| Trial | Enrollment | Size | Arm (n) | Inclusion | Diabetes at baseline (%) | New-onset diabetes (n) | New-onset diabetes criteria | |||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Study | Year | Drug | Type | sites | Duration | (n) | Treatment | Criteria | ||||||||
| CETPi | Placebo | CETPi | Placebo | CETPi | Placebo | CETPi | Placebo | |||||||||
| ILLUMINATE9 | 2007 | Torcetrapib | R, DB, PC, P | 221 sites in NA, Eu, Aus | 4.5y† | 15067 | 7533 | 7534 | 60 mg CETPi with Atorvastatin | Placebo with Atorvastatin | 45–75 yo with history CVD 1–5 mo prior or T2DM who met ADA criteria or on hypoglycemic therapy | 43.5 | 45.2 | 76 | 96 | Not reported. |
| Dal-OUTCOMES12 | 2012 | Dalcetrapib | R, DB, PC, P | 27 countries in NA, Eu, Asia, Aus | 31 mos* | 15871 | 7938 | 7933 | 600 mg CETPi with Standard of Care‡ | Placebo with Standard of Care | >45 yo with recent ACS, has completed planned coronary revascularization procedures | 24 | 25 | 403 | 516 | Post-randomization diabetes-related adverse event, new use of antihyperglycaemic medication, haemoglobin A1c ≥6.5%, or a combination of at least two measurements of serum glucose ≥7.0 mmol/L (fasting) or ≥11.1 mmol/L (random) for a person without evidence of diabetes mellitus at baseline. |
| ACCELERATE10 | 2017 | Evacetrapib | R, DB, PC, P | 36 countries in NA, SA, Eu, Asia, Aus | 26 mos* | 12092 | 6038 | 6054 | 130 mg CETPi with Standard of Care‡ | Placebo with Standard of Care | >18 yo with high risk vascular disease, treated with statin 1 month pre-screening | 68.4 | 67.9 | 175 | 200 | Fasting plasma glucose ≥7 mmol/L or 2-hour plasma glucose ≥11.1 mmol/L during an oral glucose tolerance test or HbA1c levels ≥6.5% (≥48 mmol/mol). Confirm by repeat testing on a second day. |
| REVEAL8 | 2017 | Anacetrapib | R, DB, PC, P | 41 sites in NA, Eu, China | 4.1 y | 30449 | 15225 | 15224 | 100 mg CETPi with Atorvastatin | Placebo with Atorvastatin | >50 yo with high CV risk | 37.1 | 37.2 | 510 | 571 | Post-randomization diabetes-related adverse event or the use of antihyperglycaemic medication (insulin or oral treatment) recorded on at least one follow-up visit form for a person without evidence of diabetes mellitus at baseline. |
| DEFINE11 | 2010 | Anacetrapib | R, DB, PC, P | 20 countries in NA, Eu, Asia, Aus | 18 mos | 1623 | 811 | 812 | 100 mg CETPi with Atorvastatin | Placebo with Atorvastatin | 18–80 yo with CHD or high risk of CHD | 53 | 53.2 | NA | NA | NA |
R, randomised; DB, double-blind; PC, placebo-controlled; P, parallel; CO, crossover; NA, North America; Eu, Europe; Aus, Australia; SOC, Standard of Care; ADA, American Diabetes Association; ACS, acute coronary syndrome; CV, cardiovascular; CHD, coronary heart disease; CVD, cardiovascular disease; T2DM, Type 2 Diabetes Mellitus.
*Median.
†Study was terminated at 1 year.
‡Standard of Care is statin therapy.