Table 1

Characteristics at randomization of participants in posttrial follow-up

Glargine (n = 2,351)Standard care (n = 2,367)P valueOmega-3 (n = 2,368)Placebo (n = 2,403)P value
Demographic and clinical characteristics
 Age (years)63.1 (7.6)63.3 (7.5)0.2763.0 (7.4)63.3 (7.6)0.18
 Female sex747 (32)825 (35)0.025786 (34)820 (34)0.49
 Prior cardiovascular event1,389 (59)1,372 (58)0.441,387 (59)1,405 (59)0.93
 Prior myocardial infarction866 (37)853 (36)0.57860 (36)881 (37)0.81
 Prior stroke223 (9.5)213 (9.0)0.56227 (9.6)231 (9.6)0.98
 Hypertension1,799 (77)1,792 (76)0.511,781 (75)1,843 (77)0.24
 Current smoker267 (11)271 (11)0.92267 (11)288 (12)0.45
 Any albuminuria368 (16)355 (15)0.53361 (15)353 (15)0.59
 Ankle-brachial index ≤0.9127 (5.6)153 (6.7)0.12152 (6.6)153 (6.6)0.99
Glycemic characteristics
 Diabetes with use of oral diabetes drugs1,247 (53)1,224 (52)0.351,269 (54)1,299 (54)0.73
 Diabetes with no use of diabetes drugs565 (24)591 (25)0.46553 (23)544 (22)0.56
 New diabetes181 (7.7)194 (8.2)0.53185 (7.8)199 (8.3)0.55
 IGT or IFG357 (15)358 (15)0.95361 (15)360 (15)0.80
 Duration of diabetes (years)5.22 (5.95)4.99 (5.60)0.225.05 (5.58)5.25 (6.01)0.27
 Fasting glucose (mmol/L)7.00 (6.10–8.17)6.90 (6.10–8.16)0.226.90 (6.10–8.10)6.94 (6.10–8.20)0.62
 HbA1c (%)6.38 (5.80–7.06)6.28 (5.73–7.01)0.106.30 (5.78–7.06)6.34 (5.80–7.08)0.55
 HbA1c (mmol/mol)46.2 (39.9–53.7)45.1 (39.1–53.1)0.1045.4 (39.7–53.7)45.8 (39.9–53.9)0.55
Glycemic drugs
 Metformin594 (25)585 (25)0.66576 (24)627 (26)0.16
 Sulfonylurea615 (26)606 (26)0.66642 (27)651 (27)0.99
 Other41 (1.7)48 (2.0)0.4756 (2.4)35 (1.5)0.022
Nonglycemic cardiovascular risk factors
 Systolic blood pressure (mmHg)145 (20)145 (21)0.74145 (21)145.78 (21)0.17
 Diastolic blood pressure (mmHg)84 (11)84 (11)0.9684 (11)84 (12)0.28
 Weight (kg)84.1 (16.4)85.0 (17.3)0.06883.8 (17.1)83.6 (16.6)0.71
 BMI (kg/m2)29.7 (5.0)30.2 (5.3)0.00229.7 (5.2)29.9 (5.2)0.44
 Waist-to-hip ratio
  Men0.99 (0.10)0.99 (0.09)0.890.99 (0.08)0.99 (0.10)0.25
  Women0.91 (0.09)0.91 (0.09)0.390.90 (0.09)0.91 (0.09)0.21
 Total cholesterol (mmol/L)4.85 (1.18)4.81 (1.17)0.184.80 (1.16)4.84 (1.20)0.23
 LDL cholesterol (mmol/L)2.83 (1.02)2.79 (1.00)0.192.79 (0.99)2.83 (1.02)0.20
 HDL cholesterol (mmol/L)1.21 (0.32)1.21 (0.31)0.591.21 (0.33)1.21 (0.31)0.50
 Triglycerides (mmol/L)1.60 (1.17–2.29)1.60 (1.13–2.20)0.471.60 (1.11–2.20)1.60 (1.12–2.22)0.47
 Creatinine (μmol/L)88 (21)88 (21)0.8688 (21)87 (20)0.63
 Urine ACR (mg/mmol)0.56 (0.28–1.88)0.54 (0.27–1.57)0.130.56 (0.27–1.79)0.56 (0.28–1.73)0.55
Other drugs
 Statin1,362 (58)1,378 (58)0.841,348 (57)1,412 (59)0.21
 Thiazide diuretic413 (18)423 (18)0.79411 (17)415 (17)0.93
 ACE inhibitor or ARB1,555 (66)1,594 (67)0.381,577 (67)1,591 (66)0.76
 β-Blocker1,290 (55)1,338 (57)0.251,301 (55)1,333 (55)0.72
 Other antihypertensive drug1,686 (72)1,701 (72)0.911,684 (71)1,741 (72)0.32
 Antiplatelet drug1,662 (71)1,675 (71)0.961,688 (71)1,692 (70)0.49
  • Data are n (%), mean (SD), or median (interquartile range) for skewed variables unless otherwise indicated. ACR, albumin-to-creatinine ratio; ARB, angiotensin receptor blocker; IFG, impaired fasting glucose; IGT, impaired glucose tolerance.