XML Template (2009) [7.9.2009–9:27am] [1–14]
{TANDF_FPP}CMO/CMO_A_370737(NEW).3d (CMO) [First Proof]
Current Medical Research and Opinion
C213
Volume 25, Number 3 2008
þ
z
y z
y
are
4.7)
b.i.d.
x
b.i.d. 0.2)
1.5)
5.1)
3.1)
0.1) 0.8)
2.4)
C0
C0
2.9)
C0
data
mg
41.7 38.3
C0
40.4 37.7
C0
97.7 82.8
mg
10.9 12.2
8.1) 35.5 32.1
50 166
C6 C6 4.4,
8.3,
C6 C6 1.9,
C6 C6
5.4,
12.5,
(
C0
166
(3.4,
(
C0
165
(
C0
(
C0
166
C6 C6
7.0,
11.5, 166
C6 C6
15.6,
16.3,
1000
(
C0
(
C0
(
C0
(
C0
placebo
(
C0
or
192.8 185.7
2.1
44.2 46.0
5.8
148.6 139.7
MF C0
4.9
1.6
113.1 107.7 1.1
3.9
158.0 142.5
C0
C0
6.2
C0
C0
6.9 10.1
9.7
C0 C0
C0
Sitagliptin
baseline
from
þ
change
b.i.d.
b.i.d.
1.2) 2.9) 1.8) 1.9)
3.2)
%
mg
44.5 38.5
3.0)
9.2
10.4
6.0)
37.1 32.4
5.6)
2.6)
44.1 39.4
3.3)
91.2
mg
7.3,
103.7
9.2,
50 172
C6 C6
1.6,
5.5,
C6
4.0,
C6 C6
2.8,
10.0,
(1.3, (
C0 169 171
C6 C6
2.8,
C6
C0
10.8,
500
(
C0
(
C0 171
C6
(
C0 (
C0
(
C0
(
C0 172
C6
(
(
C0
median;
195.2 192.0
44.3
3.6 0.5 114.7 111.0 152.0 147.5
MF
0.7
2.1
43.1
C0 C0
1.4
3.7
C0
0.3
2.7 148.0 3.7
C0
157.0
C0
3.8
for
C0
SD
Sitagliptin
C6
*
median
b.i.d.
or
mg
2.4) 2.9)
42.0 42.7
4.1) 5.2)
12.4
8.3)
34.4 33.8
6.1)
3.0)
42.5 42.1
4.4)
16.4)
(SD)
6.3,
110.7 126.5
15.3)
159
C6 C6
0.6,
4.5,
10.5
C6
C6 C6
2.7,
9.8,
(
C0
(
C0 160
C6
(3.5,
1.8,
157 159
C6 C6
1.9,
0.6,
(
C0
(
C0
(
C0
(
C0
(
C0 159
C6 C6
1.8,
(
C0
(
C0
190.1 190.7
1.8
1.1
42.7 45.0
5.9 147.5 145.7
deviation
C0
1.7
108.2 104.6
1.7
3.4
C0
1.3
1.7
C0
154.0 182.0
6.7 7.8
Metformin1000
standard
C6
b.i.d.
mean
cholesterol.
as
mg
3.4)
1.6) 3.0)
1.8)
A).
43.4 37.1 9.4
10.4
6.1)
34.2 31.5
4.9)
43.4 36.4
4.7)
3.1)
8.7)
113.5 107.0
12.3)
500
162
C6 C6
1.3,
5.2,
C6
4.0,
C6 C6
3.9,
10.9,
160
C6 C6
1.6,
6.0,
163
C6 C6 6.5,
3.3, lipoprotein
(
C0
(
C0 160
C6
(1.3, (
C0 159
(
C0 (
C0
(
C0
(
C0
(
C0
(
C0
expressed
components.
.
(
phase
190.0 188.5
1.1
1.8
43.2
44.6
3.7 0.5 106.8 103.6 146.7 143.9
C0 C0
0.5
4.6
C0
1.5
1.4
C0
172.0 179.0
1.1
4.3
q.d.
15
are
.
al
mg
et
study
Metformin
data
respective
100
low-density
this
24
its
of
of
q.d. week
CI).
Goldstein LDL-C,
4.3)
phase
mg
48.4 51.3
5.5)
3.8)
9.5
4.3)
1.2) 5.8)
10.1
35.1 35.3
8.9)
47.2 51.2
7.4)
5.9)
97.7
7.6)
both
and
sitagliptin
in
(95%
113.5
and
100
and
151
C6 C6
3.2,
(0.7,
C6 0.7,
6.0,
C6
0.1,
7.1,
150
C6 C6
3.5, 7.2,
(
C0
150
C6
(
C0
(
C0 149
C6
(
C0
(
C0
(0.9,
(
C0
151
C6
C6
7.5,
(
C0
(
C0
baseline
change
published
cholesterol;
192.5 195.2 3.1
42.7
0.3
43.2
1.8
2.4 111.4 113.0 149.5 151.9 4.2
is
C0
4.4
0.7
C0
1.2
149.0
155.0
1.6
C0
0.1
Sitagliptin
data
analysis;
percent
lipoprotein
placebo-controlled the
placebo.
co-administration co-administration these
the
in
median
to
34.7 40.4
5.3)
9.5 9.4
6.7)
31.5 37.0
9.7)
33.9 39.8
6.3)
83.7 82.8
7.3)
or
C6 C6
during
143
C6 C6
143
C6 C6
0.4,
—
143
C6 C6
5.1,
—
CI)
evaluate
Placebo
(0.3,
—
143
C6
(1.6,
—
143
C6
(0.5,
—
(
C0
(
C0 included
relative comparing comparing
high-density
to
24 182.3 188.5 2.8
42.9 44.2
4.2 105.5 110.3 5.1 139.4 144.4
3.0
150.0 150.0
1.1 data
(95%
used
HDL-C,
week
difference difference
at
change
difference
evaluable
methods
profiles
n
n with
cholesterol;
percent
from from total
lipid
baseline placebo n baseline placebo n baseline placebo baseline placebo mean
between-group between-group between-group
statistical
patients
TC,
n
from from from from from from
(mg/dL),
(mg/dL),
LS the the
the
the
from from change change
of
as
Fasting
*
*
for for
of
% %
for
24
(mg/dL),
24
(mg/dL),
24 24 24
6.
baseline placebo
(mg/dL),
change change change change change change change change
number
0.05 0.05 0.05
¼
C20 C20
metformin;
Parameter TC Baseline Week % % HDL-C Baseline Week % % LDL-C Baseline Week % % Non-HDL-C Baseline Week % % Triglycerides Baseline Week Median Median n expressed y
p
C20
z
p
x
p
Description MF,
Table
12
54-week efficacy and safety of sitagliptin/metformin Williams-Herman et al.
www.cmrojournal.com
!
2009 Informa UK Ltd
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34