| | | |
Exenatide†
|
Placebo or Comparator
|
---|
Study/Registry Number
|
Diabetes Management
|
Duration* (Weeks)
|
ITT (N)
|
Exposure (SY)
|
ITT (N)
|
Exposure (SY)
|
---|
DeFronzo et al, 2005
18
|
NCT00039013
|
Met
|
30
|
223
|
113.8
|
113
|
57.8
|
Buse et al, 2004
20
|
NCT00039026
|
SFU
|
30
|
254
|
123.2
|
123
|
55.1
|
Kendall et al, 2005
19
|
NCT00035984
|
Met + SFU
|
30
|
486
|
254.9
|
247
|
122.2
|
Zinman et al, 2007
24
|
NCT00099320
|
TZD ± Met
|
16
|
121
|
31.7
|
112
|
32.3
|
Kadowaki et al, 2008
27
|
NCT00382239
|
SFU ± Met
|
12
|
111
|
23.9
|
40
|
9.2
|
Gao, et al, 2009
26
|
NCT00324363
|
Met ± SFU
|
16
|
234
|
65.5
|
233
|
67.3
|
Moretto et al, 2008
28
|
NCT00381342
|
D + E
|
24
|
155
|
65.2
|
77
|
33.1
|
Gill et al, 2010
29
|
NCT00516074
|
Met and/or TZD
|
12
|
28
|
5.8
|
26
|
5.7
|
Heine et al, 2005
22
|
NCT00082381
|
Met + SFU
|
26
|
282
|
122.5
|
267
|
124.6
|
Nauck et al, 2007
23
|
NCT00082407
|
Met + SFU
|
52
|
253
|
220.1
|
248
|
228.6
|
Davis et al, 2007
25
|
NCT00099333
|
SFU or Meg and/or Met
|
16
|
33
|
7.7
|
16
|
5.2
|
Barnett et al, 2007
21
|
NCT00099619
|
Met or SFU
|
16‡
|
136
|
37.3
|
127
|
38.9
|
Totals
| |
--
|
--
|
2,316
|
1,071.6
|
1,629
|
779.9
|
- D + E = diet and exercise therapy; ITT = Intent-to-Treat Population; Meg = meglitinide; Met = metformin; OAD = oral antidiabetic medications; SFU = sulfonylurea; TZD = thiazolidinedione
- *Duration of treatment with randomized study medication
- †Includes treatment with exenatide 2.5 mcg or 5 mcg BID for duration of study, or 4 weeks of exenatide 5 mcg BID followed by exenatide 10 mcg BID for remainder of study
- ‡NCT00099619 had a crossover design, with 16 weeks per period (exenatide or insulin glargine)