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Table 1 Summary of controlled studies included in CV analysis

From: Cardiovascular safety of exenatide BID: an integrated analysis from controlled clinical trials in participants with type 2 diabetes

    

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

  1. D + E = diet and exercise therapy; ITT = Intent-to-Treat Population; Meg = meglitinide; Met = metformin; OAD = oral antidiabetic medications; SFU = sulfonylurea; TZD = thiazolidinedione
  2. *Duration of treatment with randomized study medication
  3. †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
  4. ‡NCT00099619 had a crossover design, with 16 weeks per period (exenatide or insulin glargine)
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Cardiovascular Diabetology

ISSN: 1475-2840