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Table 2 Change in diabetes end points following IPE treatment in diabetes subgroups by median baseline A 1c

From: Effects of icosapent ethyl on lipid and inflammatory parameters in patients with diabetes mellitus-2, residual elevated triglycerides (200–500 mg/dL), and on statin therapy at LDL-C goal: the ANCHOR study

Parameter

All patients with diabetes mellitus

A1c<6.8%

A1c≥6.8%

All patients with diabetes mellitus

A1c<6.8%

A1c≥6.8%

IPE dose (n=all patients, A1c<6.8%, A1c ≥6.8%)

Baseline

End of treatment

Baseline

End of treatment

Baseline

End of treatment

Placebo-adjusted change from baseline, %, p

FPG, mg/dL

         

4 g/day

143

154

122

133

161

172

3.7

2.7

4.0

(n=160, 75, 85)

(38)

(53)

(23)

(37)

(39)

(59)

0.16

0.38

0.35

2 g/day

146

150

123

127

167

171

0.1

-2.8

2.6

(n=165, 79, 86)

(44)

(47)

(25)

(26)

(47)

(51)

0.99

0.36

0.54

Placebo

140

145

124

130

158

163

   

(n=158, 86, 72)

(35)

(39)

(25)

(30)

(37)

(41)

   

A 1c , %

         

4 g/day

6.9

7.2

6.2

6.5

7.6

7.9

1.4

1.3

1.7

(n=161, 76, 85)

(0.9)

(1.1)

(0.3)

(0.6)

(0.7)

(1.1)

0.14

0.27

0.29

2 g/day

7.0

7.2

6.2

6.3

7.8

8.0

0.1

-0.4

0.8

(n=167, 79, 88)

(1.1)

(1.2)

(0.4)

(0.5)

(0.9)

(1.1)

0.88

0.71

0.59

Placebo

6.8

7.0

6.2

6.4

7.5

7.7

   

(n=158, 86, 72)

(0.9)

(1.1)

(0.4)

(0.7)

(0.7)

(0.9)

   

Insulin, μIU/mL

         

4 g/day

20.6

18.5

20.0

19.3

21.2

17.7

-5.9

0.6

-13.4

(n=159, 76, 83)

(16.0)

(10.6)

(12.1)

(9.8)

(19.0)

(11.3)

0.43

0.95

0.26

2 g/day

18.9

19.1

16.8

17.4

21.1

20.7

-4.1

9.2

-17.8

(n=157, 79, 78)

(11.6)

(10.9)

(9.3)

(9.0)

(13.2)

(12.5)

0.59

0.32

0.14

Placebo

25.4

21.5

27.5

19.6

22.8

23.8

   

(n=156, 85, 71)

(38.2)

(18.9)

(48.2)

(13.9)

(20.6)

(23.5)

   

HOMA-IR

         

4 g/day

7.5

7.3

6.1

6.4

8.8

8.1

-1.4

3.0

-7.1

(n=158, 75, 83)

(7.5)

(6.2)

(3.8)

(3.7)

(9.5)

(7.7)

0.88

0.79

0.64

2 g/day

7.0

7.1

5.2

5.5

8.8

8.7

-8.8

6.0

-23.9

(n=157, 79, 78)

(5.0)

(4.8)

(3.4)

(3.1)

(5.6)

(5.6)

0.36

0.60

0.13

Placebo

9.6

7.9

9.7

6.4

9.4

9.6

   

(n=156, 85, 71)

(19.0)

(7.6)

(24.1)

(5.0)

(9.9)

(9.6)

   
  1. Mean and standard deviation (SD) are reported for baseline and end-of-treatment values. Least-squares means are reported for the placebo-adjusted changes from baseline.
  2. A1c = glycosylated hemoglobin A1c; FPG = fasting plasma glucose; HOMA-IR = homeostasis model assessment-estimated insulin resistance; IPE = icosapent ethyl.