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Q
Q
BT
0.15 1 1 0 k
/GS0 gs
/T1_1 1 Tf
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[(ALL INFORMA)80(TION GIVEN IS INTENDED FOR MEDICAL MEDIA ONL)111.3(Y)111(. FOR JOURNALISTIC ASSESSMENT AND PREP)74.1(ARA)80.1(TION BEFORE PUBLICA)80(TION IN MEDICAL MEDIA.)]TJ
ET
q
700.158 207.54 m
694.489 207.54 694.489 201.871 v
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700.158 41.503 l
800.221 41.503 l
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h
W n
q
0 g
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BX /Sh0 sh EX Q
Q
q
700.158 217.117 m
694.488 217.117 694.488 211.447 v
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800.221 182.321 l
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h
W n
q
0 g
103.6905136 -50.5732422 -50.5732422 -103.6905136 698.3437195 225.0055389 cm
BX /Sh1 sh EX Q
Q
BT
0 0 0 0 k
/T1_1 1 Tf
11 0 0 11 733.4772 202.0939 Tm
(Safety )Tj
-1.222 -1.182 Td
(Evaluations)Tj
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<00740001>Tj
/T1_0 1 Tf
0.945 0 Td
[(Analysis of exposur)18.1(e )]TJ
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-0.945 -1.426 Td
<00740001>Tj
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0.945 0 Td
(Adverse events)Tj
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-0.945 -1.426 Td
<00740001>Tj
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0.945 0 Td
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(episodes)Tj
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0.945 0 Td
[(V)-6(ital signs)]TJ
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-0.945 -1.426 Td
<00740001>Tj
/T1_0 1 Tf
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(Physical \037ndings)Tj
ET
q 1 0 0 1 628.7507 388.028 cm
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S
Q
q
0 0 841.89 595.276 re
W n
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h
f
Q
Q
BT
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/T1_0 1 Tf
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(Liraglutide 1.8 mg + met)Tj
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(\206)Tj
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( )Tj
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(\261 pio)Tj
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(\207)Tj
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(\(n=313\))Tj
ET
q
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W n
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h
f
Q
Q
BT
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(Insulin degludec + met)Tj
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(\206)Tj
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( )Tj
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(\261 pio)Tj
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ET
q
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W n
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90.709 0 87.874 0 v
h
f
Q
Q
BT
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(IDegLira + met)Tj
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(\206)Tj
7 0 0 7 594.7145 390.6469 Tm
( \261 pio)Tj
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(\207)Tj
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(\(n=665\))Tj
ET
q
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W n
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78.671 0 75.836 0 v
h
f
Q
Q
BT
/T1_0 1 Tf
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(Liraglutide 1.8 mg + )Tj
0 -1 TD
(met)Tj
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(\206)Tj
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( \261 pio)Tj
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(\207)Tj
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(\(n=415\))Tj
ET
q
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W n
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78.671 0 75.836 0 v
h
f
Q
Q
BT
/T1_0 1 Tf
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[(Insulin degludec )0.5(+ met)]TJ
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(\206)Tj
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( )Tj
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(\261 pio)Tj
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(\207)Tj
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(\(n=414\))Tj
ET
q
0 0 841.89 595.276 re
W n
1 0.05 0.05 0 k
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78.671 0 75.836 0 v
h
f
Q
Q
BT
/T1_0 1 Tf
7 0 0 7 384.3628 389.2468 Tm
(IDegLira + met)Tj
4.081 0 0 4.081 428.2242 391.5778 Tm
(\206)Tj
7 0 0 7 430.4932 389.2468 Tm
( \261 pio)Tj
4.081 0 0 4.081 447.923 391.5778 Tm
(\207)Tj
7 0 0 7 384.3628 382.2468 Tm
(\(n=834\))Tj
ET
q
0 0 841.89 595.276 re
W n
/CS2 cs 0.29 scn
q 1 0 0 1 317.6094 401.8797 cm
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54.871 -116.279 54.871 -113.444 v
54.871 -2.835 l
54.871 0 52.037 0 v
h
f
Q
Q
BT
/T1_0 1 Tf
7 0 0 7 320.4441 380.1154 Tm
(Open label )Tj
0 -1.2 TD
(randomisation )Tj
T*
(\(2:1:1\) to )Tj
T*
[(r)18(eceive either )]TJ
T*
(IDegLira, )Tj
T*
(insulin )Tj
T*
(degludec or )Tj
T*
(liraglutide once )Tj
0 -1.371 TD
(daily)Tj
ET
q
0 0 841.89 595.276 re
W n
/CS2 cs 0.29 scn
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52.037 -116.279 l
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54.871 -2.835 l
54.871 0 52.037 0 v
h
f
Q
Q
BT
/T1_0 1 Tf
7 0 0 7 477.8059 362.1154 Tm
(Extension )Tj
0 -1.2 TD
(Phase )Tj
T*
(examined )Tj
T*
(sustainability )Tj
T*
(of endpoints )Tj
T*
(\(n=1311\))Tj
ET
q
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W n
/CS2 cs 0.29 scn
q 1 0 0 1 527.0081 257.849 cm
0 0 m
-2.835 0 -2.835 -2.835 v
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-2.835 -25.512 0 -25.512 v
65.109 -25.512 l
67.944 -25.512 67.944 -22.677 v
67.944 -2.835 l
67.944 0 65.109 0 v
h
f
Q
Q
BT
/T1_0 1 Tf
7 0 0 7 529.8427 246.6681 Tm
(Continued allotted )Tj
T*
[(tr)18(eatment)]TJ
ET
q
41.669 199.112 m
36 199.112 36 193.443 v
36 193.443 l
36 47.174 l
36 41.503 41.669 41.503 v
41.669 41.503 l
678.282 41.503 l
683.951 41.503 683.951 47.174 v
683.951 47.174 l
683.951 193.443 l
683.951 199.112 678.282 199.112 v
678.282 199.112 l
h
W n
q
0 g
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BX /Sh0 sh EX Q
Q
q
41.669 217.095 m
36 217.095 36 211.426 v
36 211.426 l
36 200.087 l
36 194.418 41.669 194.418 v
41.669 194.418 l
678.282 194.418 l
683.951 194.418 683.951 200.087 v
683.951 200.087 l
683.951 211.426 l
683.951 217.095 678.282 217.095 v
678.282 217.095 l
h
W n
q
0 g
532.3519287 -259.6453857 -259.6453857 -532.3519287 93.7999039 335.5791626 cm
BX /Sh1 sh EX Q
Q
BT
/T1_1 1 Tf
11 0 0 11 53.0079 201.6315 Tm
(Dosing)Tj
ET
q
0 0 841.89 595.276 re
W n
1 0.05 0.05 0 k
q 1 0 0 1 50.1732 169.3492 cm
0 0 m
-2.835 0 -2.835 -2.835 v
-2.835 -39.685 l
-2.835 -42.52 0 -42.52 v
266.019 -42.52 l
268.854 -42.52 268.854 -39.685 v
268.854 -2.835 l
268.854 0 266.019 0 v
h
f
Q
Q
BT
/T1_0 1 Tf
9 0 0 9 53.0079 155.5143 Tm
(Initiation dose for IDegLira was 10 dose steps \(10 units insulin )Tj
T*
(degludec /0.36 mg liraglutide\). Maximum dose of 50 dose steps \(50 )Tj
T*
(units insulin degludec + 1.8 mg liraglutide\).)Tj
ET
q
0 0 841.89 595.276 re
W n
0 0.14 0.19 0.6 k
q 1 0 0 1 50.1732 101.3209 cm
0 0 m
-2.835 0 -2.835 -2.835 v
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266.019 -53.858 l
268.854 -53.858 268.854 -51.024 v
268.854 -2.835 l
268.854 0 266.019 0 v
h
f
Q
Q
BT
/T1_0 1 Tf
9 0 0 9 53.0079 87.2168 Tm
[(Liraglutide tr)18.1(eatment was initiated at 0.6 mg/day for the \037rst week )]TJ
T*
[(of tr)18(eatment, followed by weekly dose escalation steps of 0.6 mg )]TJ
T*
[(for the following two weeks, r)18.1(eaching the maximum daily dose of )]TJ
T*
[(1.8 mg by the thir)18.1(d week.)]TJ
ET
q
0 0 841.89 595.276 re
W n
1 0.75 0 0.35 k
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0 0 m
-2.835 0 -2.835 -2.835 v
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266.019 -19.843 l
268.854 -19.843 268.854 -17.008 v
268.854 -2.835 l
268.854 0 266.019 0 v
h
f
Q
Q
BT
/T1_0 1 Tf
9 0 0 9 53.0079 110.7002 Tm
(Initiation dose of insulin degludec was 10 units; no maximum dose.)Tj
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(<4.0 \(<72\))Tj
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(4.0-5.0 \(72-90\))Tj
0.984 -2.01 Td
(>5.0 \(>90\))Tj
-4.293 -1.984 Td
[(T)-24(itration algorithm for dose adjustment of IDegLira or insulin )]TJ
T*
(degludec in the DUAL\231 phase 3a trials. Dose adjustments )Tj
T*
[(wer)18(e made based on SMBG values with a target FPG \(fasting )]TJ
T*
(plasma glucose\) of 4.0-5.0 mmol/L \(72-90 mg dL\).)Tj
19.877 9.604 Td
(-2)Tj
0.166 -2.01 Td
(0)Tj
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(+2)Tj
ET
q
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486.141 169.349 486.141 166.514 v
486.141 166.514 l
486.141 143.837 l
486.141 141.003 488.976 141.003 v
488.976 141.003 l
575.167 141.003 l
578.002 141.003 578.002 143.837 v
578.002 143.837 l
578.002 166.514 l
578.002 169.349 575.167 169.349 v
575.167 169.349 l
h
W n
q
0 g
87.8901443 -34.9757385 -34.9757385 -87.8901443 488.1191559 172.6482162 cm
BX /Sh1 sh EX Q
Q
BT
0 0 0 0 k
/T1_1 1 Tf
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(Mean fasting plasma )Tj
1.779 -1 Td
(glucose \(FPG\))Tj
/T1_0 1 Tf
-0.195 -1 Td
(mmol/L \(mg/dL\))Tj
ET
q
585.297 169.349 m
582.463 169.349 582.463 166.514 v
582.463 166.514 l
582.463 143.837 l
582.463 141.003 585.297 141.003 v
585.297 141.003 l
671.488 141.003 l
674.322 141.003 674.322 143.837 v
674.322 143.837 l
674.322 166.514 l
674.322 169.349 671.488 169.349 v
671.488 169.349 l
h
W n
q
0 g
87.8901443 -34.9757385 -34.9757385 -87.8901443 584.4401093 172.6482162 cm
BX /Sh1 sh EX Q
Q
BT
/T1_1 1 Tf
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(Dose change)Tj
/T1_0 1 Tf
-1.252 -1 Td
(\(dose steps or units\))Tj
ET
0.5 w
q 1 0 0 1 486.1417 122.9964 cm
0 0 m
188.181 0 l
S
Q
q 1 0 0 1 486.1417 108.898 cm
0 0 m
188.181 0 l
S
Q
BT
1 0.75 0 0.35 k
/T1_0 1 Tf
7 0 0 7 375.5636 141.1641 Tm
(1 U insulin degludec)Tj
4.035 -1.2 Td
(+)Tj
-4.034 -1.2 Td
(0.036 mg liraglutide)Tj
-0.279 -5.648 Td
(50 U insulin degludec)Tj
4.313 -1.2 Td
(+)Tj
-3.478 -1.2 Td
(1.8 mg liraglutide)Tj
ET
q
339.439 169.349 m
336.604 169.349 336.604 166.514 v
336.604 166.514 l
336.604 154.959 l
336.604 152.125 339.439 152.125 v
339.439 152.125 l
473.554 152.125 l
476.389 152.125 476.389 154.959 v
476.389 154.959 l
476.389 166.514 l
476.389 169.349 473.554 169.349 v
473.554 169.349 l
h
W n
q
0 g
127.3813553 -29.1742229 -29.1742229 -127.3813553 342.7603149 175.2361336 cm
BX /Sh1 sh EX Q
Q
BT
0 0 0 0 k
/T1_1 1 Tf
7 0 0 7 387.8278 158.1121 Tm
(1 dose step)Tj
ET
q
340.087 113.145 m
337.253 113.145 337.253 110.311 v
337.253 110.311 l
337.253 98.486 l
337.253 95.652 340.087 95.652 v
340.087 95.652 l
472.905 95.652 l
475.74 95.652 475.74 98.486 v
475.74 98.486 l
475.74 110.311 l
475.74 113.145 472.905 113.145 v
472.905 113.145 l
h
W n
q
0 g
126.2112503 -29.6025791 -29.6025791 -126.2112503 343.3516388 119.1247063 cm
BX /Sh1 sh EX Q
Q
BT
/T1_1 1 Tf
7 0 0 7 384.3278 101.7736 Tm
(50 dose steps)Tj
1 0.75 0 0.35 k
8 0 0 8 337.0308 179.0793 Tm
(De\037nition of an IDegLira dose step)Tj
20.815 0 Td
(Titration algorithm for dose adjustments)Tj
/T1_4 1 Tf
-0.01 Tc 9 0 0 9 47.3386 178.3293 Tm
(Participants on metformin and pioglitazone continued at pre-trial doses)Tj
0 0 0 1 k
/GS1 gs
/T1_0 1 Tf
0 Tc 7 0 0 7 673.3773 16.75 Tm
[(APROM 6253 Date of Appr)18.1(oval: May / 2014)]TJ
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